Global Journal of Medical Research

Volume 12 Issue 11 Version 1.0 Year 2012

Type: Double Blind Peer Reviewed International Research Journal
Publisher: Global Journals Inc. (USA)
Online ISSN: 2249-4618 Print ISSN:0975-5888

To Evaluate the Clinical Efficacy of Tila E Hadaf in the

Management of Erectile Dysfunction
By Izharul Hasan, Danish Kamal Chishti, Fakhra Talat & Yusuf Jamal
AU Tibbia College and Hospital
Abstract - The effect of erectile dysfunction potentially interferes with men’s self esteem,
confidence, relationship, and overall sense of well being. The problem is increasing in all
segments of the sexually active male population and affects both men and his partner. In
younger man increase is attributed to substance abuse, such as recreation drugs and alcohol.
Middle aged men are affected by medical conditions such as diabetes, hypertension, sexual
diseases, organ transplant, coronary artery bypass surgeries and cancer, or the therapy of these
problems. The older population is living longer, fuller lives and expects to remain sexually active,
regardless of any existing medical conditions. Stress factors associated with modern life styles
are affecting men of all ages and contribute greatly to the overall causes of erectile failure. Early
identification, behavior modification and increased therapeutic options may improve patient’s
outcome. By improving the knowledge and therapeutic options, it may be possible to identify
patients at risk of erectile dysfunction and thus to lead a normal healthy life.
Keywords : erectile dysfunction, Tila e Hadaf.
GJMR-L Classification : NLMC Code : WM 611

To Evaluate the Clinical Efficacy of Tila E Hadaf in the Management of Erectile Dysfunction

Strictly as per the compliance and regulations of :

© 2012 Izharul Hasan, Danish Kamal Chishti, Fakhra Talat & Yusuf Jamal. This is a research/review paper, distributed under the
terms of the Creative Commons Attribution-Noncommercial 3.0 Unported License http://creativecommons.org/licenses/by-
nc/3.0/), permitting all non commercial use, distribution, and reproduction in any medium, provided the original work is properly
cited.
 To Evaluate the Clinical Efficacy of Tila E Hadaf
in the Management of Erectile Dysfunction
Izharul Hasan α, Danish Kamal Chishti σ, Fakhra Talat ρ & Yusuf Jamal Ѡ

Abstract - The effect of erectile dysfunction potentially experienced them before age 40, and four percent had
interferes with men’s self esteem, confidence, relationship, experienced problems between age 40 and 49. From
and overall sense of well being. The problem is increasing in age 50 upwards, the percentage of men reporting ED

Year 2012
all segments of the sexually active male population and affects increased dramatically with 26 percent between the
both men and his partner. In younger man increase is ages of 50 to 59, 40 percent aged 60 to 69 years and 61
attributed to substance abuse, such as recreation drugs and percent for men older than 70 having experienced ED.
alcohol. Middle aged men are affected by medical conditions
The study demonstrated that erectile dysfunction is
such as diabetes, hypertension, sexual diseases, organ
transplant, coronary artery bypass surgeries and cancer, or increasingly prevalent with age. At age 40, there is an 53
the therapy of these problems. The older population is living approximately 40% prevalence rate, increasing to almost
longer, fuller lives and expects to remain sexually active, 70% in men at age 70. The prevalence of moderate

Global Journal of Medical Research Volume XII Issue XI Version I

regardless of any existing medical conditions. Stress factors erectile dysfunction increases from 17% to
associated with modern life styles are affecting men of all ages approximately 34%; the prevalence of complete erectile
and contribute greatly to the overall causes of erectile failure. dysfunction increases from 5% to 15% as age increases
Early identification, behavior modification and increased from 40 to 70 years (Feldman HA, Goldstein I,
therapeutic options may improve patient’s outcome. By Hatzichristou DG 1994).
improving the knowledge and therapeutic options, it may be
The Massachusetts Male Aging Study reported
possible to identify patients at risk of erectile dysfunction and
thus to lead a normal healthy life. The present study reveals a prevalence of 52% in men aged 40 to 70 (Feldman HA
that overall effect of Tila e Hadaf was found quite encouraging et al 1994). It is estimated that in 1995 there were over
in the treatment of erectile dysfunction and significant 152 million men worldwide who experienced erectile
improvement was observed in subjective parameters. dysfunction. With the ageing worldwide population, it
Keywords : erectile dysfunction, tila e hadaf. has been projected that by the year 2025, 322 million
men will have some degree of erectile dysfunction (Ayta
I. Introduction IA, McKinlay JB, Krane RJ 1999). Data on the

E
rectile dysfunction (ED) is defined as the inability prevalence of ED in Asia are limited. A recent study
to achieve or maintain an erection sufficient for conducted in Thailand reported an overall prevalence
satisfactory sexual performance (Impotence NIH rate of 37.5% amongst men 40 to 70 years of age
Consensus Statement 1992). The researchers assessed (Kongkanand A 2000). No observational studies on
the sexual function of 31,742 men between the ages of erectile dysfunction have been done in Delhi previously.
53 and 90, who were enrolled in the Health With an ageing population, erectile dysfunction may
Professionals Follow-up Study and had responded to a become a significant health problem.
questionnaire mailed in 2000 that, among other Keeping this fact in mind and a high prevalence
questions related to health, asked about sexual function, of erectile dysfunction, this Pilot study was conducted in
physical activity, body weight, smoking and marital Ayurvedic and Unani Tibbia College Hospital by
status. Men who had been diagnosed with prostate Department of Physiology to find out the clinical efficacy
cancer were excluded from the findings. Thirty-three of Tila e Hadaf in the management of erectile
percent of the participants reported experiencing erectile dysfunction. The objective of this study was to test the
dysfunction in the previous three months. ED was clinical efficacy of Tila e Hadaf a branded Unani
defined as the inability, without treatment, to have and medicine manufactured by Sangam Pharmacy, 2922,
maintain an erection adequate for intercourse (Feldman Kithore, Didtrict Meerut, (UP)-250104, India on erectile
HA, Goldstein I, Hatzichristou DG). dysfunction. This was an 8 week, randomized, single
Fewer than two percent of the men in the study blind, observational study.. A total of 100 subjects were
who reported that they had erection problems randomly selected. Medicine was supplied by the
hospital store.

Author α : Dept of juris & toxicology, AU Tibbia College and Hospital,

II. Methodology
Karolbagh New Delhi. E-mail : [email protected] The “Clinical efficacy of Tila e Hadaf in the
Author σ, ρ, Ѡ : Dept of Physiology, AU Tibbia College & Hospital,
New Delhi. management of erectile dysfunction” was conducted at

© 2012 Global Journals Inc. (US)

 To Evaluate the Clinical Efficacy of Tila E Hadaf in the Management of Erectile Dysfunction

the hospital of Ayurvedic and Unani Tibbia College i. Family type

Delhi. This study was conducted from June 2012 to The families were classified as follows:
December 2012. Nuclear family : Married couple and their children, where
the children are still regarded as dependant.
a) Criteria for Selection of patients
i. Inclusion Criteria Joint family : Consists of number of married couples and
their children who live in the same household.
Patients of
• Male between the ages of 20 to 50 years. ii. Occupation of subjects
• At least a 3-month history of erectile dysfunction The occupation of the parents was recorded as
(ED). the determinant of the SES.
• Are able to read, understand and provide signed
informed consent. iii. Literacy of the subjects
Year 2012

The data related to the literacy of the subjects

• Agree not to use any other erectile dysfunction
was assessed to know the educational status and the
(ED) treatment, including herbal therapy during
socioeconomic status.
the 8-week non-drug, run-in.
2
54 ii. Exclusion Criteria iv. Socioeconomic status (SES)
• Patients below the age of 20 and above 50 The SES was assesses by using the
years. Kuppuswami’s SES Scale for Urban population, 1976.
Global Journal of Medical Research Volume XII Issue XI Version I

Due to changes in the economy to year, the

• Patients having anxiety associated with organic
classification or scale was modified accordingly. The
illnesses like hypertension, ischemic heart
latest SES scale is of 2012.
disease, diabetes mellitus, renal diseases,
Tuberculosis etc. g) Duration of protocol
The treatment period of test formulation was
b) Informed consent
determined as 60 days.
Patients enrolled into study were given the
information sheet having details about the nature of the h) Trial formulation
study, the drug to be used, method of treatment and Tila e Hadaf as local application on penis;
they were allowed to go through the contents of composition of as follows.
informed consent form accordingly to ask any question Kharateen (Earth worm)200 mg (Guerrero RD III. 2009).
related to study, they were asked to sign the informed
Beerbahuti(Coccus cacti) 200 mg (Nobel, Park S.
consent form.
2002).
c) Investigations Jund Bedustar (Castoreum)100 mg (Müller-Schwarze,
Investigations were carried out aiming: D and Houlihan 1991).
• To exclude the patients with pathological Laung (Cloves)100 mg (Tajuddin , Ahmad S. 2004).
conditions mentioned under exclusion criteria. Aqarqarha (Anacyclus pyrethrum)100 mg.
• To establish safety and validation of test drugs.
Roghan Zaitun (Olive oil) qs.
d) Study design
This study was designed as a Randomized i) Method of preparation and mode of administration
single blind observational study. of test drug
The Tila e Hadaf for trial formulation was
e) Sample size provided by Sangam Pharmacy Meerut. Tila Hadaf was
The sample size was fixed as 100 patients who dispensed to the patients allocating in test group in the
fulfill the inclusive criteria for the study. transparent glass bottle in sufficient quantity to last for 7
days.
f) Study and data collection i. Dosage
The study is the test run study, conducted in To be rubbed on the penis. Just 4-5 drops are
different population with similar characteristic. The data to be massaged on the male organ 1- 2 times a day.
for the study was collected from 100 married males
based on objectives of the study; a structured j) Follow up during treatment
questionnaire has been developed to assess the Two month study was divided into eight visits of
knowledge of regarding erectile dysfunction at A & U follow up, which were made at an interval of 7 days. At
Tibbia college Hospital, Karol Bagh, New Delhi, from every visit, patients were asked about the progression or
June 2012 to Dec 2012. A formal written permission was regression in their symptoms, and subjected to assess
taken from Head of the Dept of physiology, A & U Tibbia the clinical findings. Concomitant treatment was not
College and Hospital to conduct the study. allowed during study.

© 2012 Global Journals Inc. (US)

 To Evaluate the Clinical Efficacy of Tila E Hadaf in the Management of Erectile Dysfunction

k) Efficacy assessment to a harder and long-lasting erection when aroused.

The efficacy of the treatment in test group was Gives enhanced sexual pleasure and more intense
assessed on the basis of subjective and objective orgasm. It has been proven to be safe and without any
parameters. known side-effects. It is an effective remedy to normalize
the hypersensitization of male organ due to
l) Withdrawal criteria spermatorrhea, premature ejaculation or excess of
a. Failure to follow the protocol coitus.
b. Any adverse event The sensitivity of the sexual organs increases
c. Drug defaulters abnormally as a result of masturbation, hyper
m) Adverse drug reaction documentation sensitiveness, premature ejaculation, nocturnal emission
Any adverse event or reaction that appears (wet dream), spermatorrhoea and excessive sexual
during the study. intercourse. It becomes essential to bring the sensitivity
of the sexual organs to normal level in order to cure the
n) Data analysis

Year 2012
said diseases. Excessive nocturnal emission (wet
Data were tabulated in a systematic way for
dream) and spermatorrhoea cause pricking on the
presentation and analysis on the basis of recorded
gland which produces Mazi (a fine liquid that flows
parameters.
before the discharge of semen), such a pricking causes
o) Documentation frequent erection and pain in testicles. Such conditions 55
The case record form and consent forms adversely affect the growth of the penis.
properly documented throughout the study. Tila Hadaf is the compound of such

Global Journal of Medical Research Volume XII Issue XI Version I

In view of the nature of the problem selected for components which give potency to the male sexual
the study and the objectives to be accomplished, this organs and bring their sensitiveness to a normal level.
study designed as a Randomized single blind They also regulate the circulation of blood and give
observational study was found appropriate. energy to the nerves and muscles of penis. Its use
i. Mechanism of action of Tila e Hadaf in Erectile makes away with the harmful effects of masturbation.
dysfunction Tila Hadaf also potentiates nerves and muscles of the
Tila e Hadaf manufactured by Sangam male organ.
Pharmacy, is special oil with all unique natural
III. Observation and Result
ingradients known for ages as per unani ssystem of
medicines to treat the erectile dysfunction. Tila e Hadaf The sample of 100 married male from A & U
helps supply the penis with all the essential nutrients it Tibbia College Hospital, Karol Bagh Delhi was taken
needs. Besides offering natural gains in the length and from the population, by using convenient sampling. The
girth of the penis they improve many aspects of penis personal data obtained include age, educational status,
health. It is natural penis enhancement oil that increases occupation, family income, religion, type of family,
blood flow to the penile erectile chambers which leads duration of married life, and place of residence.

30
30 29
30 22 29
22
19
20 19
Number of
subjects
10
Percentage
0
21-25 26-30
31-35 >36

Figure 1 : Distribution of patients according to age.

Figure 1 reveals the percentage distribution of group of more than 36 year. Thus it is seen most of the
the married males according to the age group. Majority married males participated in the study were below 50
of the married males (30.00%) were between the age years of age. Most of the males were between 25-35
group of 26-30 years, 23.00% were in age group years of age which could be attributed to performance
between 21-25 years, 29.00% were between the age anxiety and other psychogenic factors.
group of 31-35 years and only 19.00% were in the age

© 2012 Global Journals Inc. (US)

 To Evaluate the Clinical Efficacy of Tila E Hadaf in the Management of Erectile Dysfunction

Distribution of married males according to

educational status

40 28 31
24
30 17
20
10
0 Percentage
Year 2012

Figure 2 : Distribution of the married males according to educational status.

56
2 Figure 2 shows that in educational status secondary education and 17% had graduate and above
majority of married males (31.00%) had studied upto educational qualification. This shows that majority of
secondary, 28% had primary education, 24% had higher participants were having secondary education.
Global Journal of Medical Research Volume XII Issue XI Version I

40

20
32
0 25
0 19 24

Figure 3 : Distribution of married males according to occupation.

Figure 3 shows that majority of married males Thus it is seen that most of the married males had an
32% were unemployed, 25% were skilled, 19% were occupation.
semiskilled, and 24% were unskilled worker respectively.

50
45 45
40
35
30 30
25 25 Number of subjects
20
Percentage
15
10
5
25.00% 45.00% 30.00%
0
0 1 2 3 4

Figure 4 : Distribution of married males according to socio-economic status.

© 2012 Global Journals Inc. (US)
 To Evaluate the Clinical Efficacy of Tila E Hadaf in the Management of Erectile Dysfunction

Figure 4 shows that out of total 100 married (45.00%) were from lower middle (3) SES. This can be
males in the study 25% were from upper middle (2) SES, attributed to lower educational and occupational status
45% were from lower middle (3) SES, and 30% were of subjects (Figure 4).
from upper lower (4) SES. Maximum numbers, 45

70
60
60
50
40 36
Subjects
30
Percentage

Year 2012
20
4
10
0 60.00% 36.00% 4.00%
57
-10 0 1 2 3 4

Global Journal of Medical Research Volume XII Issue XI Version I

Figure 5 : Distribution of subjects according to religion.

Figure 5 shows that 60% of the subjects were that majority of the subjects were from Hindu
from Hindu community, 36% subjects were from Muslim community.
community and 4% from other communities. This shows

120

100 45

80

60 Joint
55
40 Nuclear

20
45.00%
0 55.00%
Subjects Percentage

Figure 6 : Distribution of subjects according to family type. .

Figure 6 depicts that 55% of the subjects were Hence it is clear majority of the subjects who
from nuclear family and 45% were from joint family. participated in the study were from nuclear family.

© 2012 Global Journals Inc. (US)

 To Evaluate the Clinical Efficacy of Tila E Hadaf in the Management of Erectile Dysfunction

40
35 34
30 31

25 24
20 Subjects
15 Percentage
10 11

5
Year 2012

0 34.00% 24.00% 31.00% 11.00%

0 1 2 3 4 5

58
2
Figure 7 : Distribution of subjects according to duration of married life.
Figure 7 shows that 34% of the subjects had 0-5 years duration of married life, and 11% subjects had
Global Journal of Medical Research Volume XII Issue XI Version I

years duration of married life, 24% subjects had 6-10 more than 15 years duration of married life.
years duration of married life, 31% subjects had 11-15

100 33
Series2
67
Urban
0
33.00%
67.00%
Subjects

Percentage

Figure 8 : Distribution of subjects according to area of residence.

Figure 8 depicts that 67% of the subjects were rural area. This shows that majority of the cases were
from urban area whereas 33% of the subjects were from from urban area.

Table 1 : Distribution of subjects according to situation in terms of a full erection.

Situation in terms of full Number of subjects Percentage
erection
Never get a full rigid 51 51.00%
erection
Full rigid erection in 49 49.00%
some situations
Total 100 100.00%

© 2012 Global Journals Inc. (US)

 To Evaluate the Clinical Efficacy of Tila E Hadaf in the Management of Erectile Dysfunction

49 49.00%
60 51

40
Never get Full rigid
20 erection

51.00% Get full rigid erection

0 in some situation

Year 2012
No. of
Subjects Percentage

59

Figure : 9

Global Journal of Medical Research Volume XII Issue XI Version I

Table 1 and figure 9 depicts that 51% of the majority of the subjects 51.00% participate in the study
subjects had never got a full rigid erection and 49% had never got a full rigid erection.
got full rigid erection in some situations. Hence it is clear

Table 2 : Effect of Tila e Hadaf on Erectile dysfunctions at end of study.

Grade Number of subjects Percentage
Grade 0 8 8.00%
Grade I 25 25.00%
Grade II 50 50.00%
Grade III 17 17.00%

50
50
45
40
35
30 25
25 Subjects

20 17 Percentage
15
8
10
5 8.00% 25.00% 50.00% 17.00%
0
Grade 0 Grade I Grade II Grade III

Figure : 10

© 2012 Global Journals Inc. (US)

 To Evaluate the Clinical Efficacy of Tila E Hadaf in the Management of Erectile Dysfunction

Table 2 and figure 10 depicts that at the end of The present study shows that 34% of the
treatment, 8% of the subjects had got grade 0 subjects had 0-5 years duration of married life, 24%
meanwhile no improvement, whereas 25% of the subjects had 6-10 years duration of married life, 31%
subjects had got grade I, 50% of the subjects had got subjects had 11-15 years duration of married life, and
grade II, and 17% of the subjects got grade III 11% subjects had more than 15 years duration of
improvement respectively. This shows majority of the married life.
cases had got grade II and were having satisfactory The present study depicts that 67% of the
improvement. subjects were from urban area whereas 33% of the
subjects were from rural area. This shows that majority
IV. Conclusion of the cases were from urban area.
Satisfactory sex life is an important influencing The present study depicts that 51% of the
factor for a harmonious marriage and relationship. subjects had never got a full rigid erection and 49% had
Year 2012

Sexual problems like erectile dysfunction deeply effects got full rigid erection in some situations. Hence it is clear
personal life causing isolation, frustration and decreased majority of the subjects 51.00% participating in the study
self-esteem, which may extend into their job never got a full rigid erection.
performance and interaction with others. The present study depicts that at the end of
2
60 study, 8% of the subjects had got grade 0 meaning no
Keeping this fact of high prevalence of ED in
mind, A clinical study was carried out under Prof. Dr improvement, whereas 25% of the subjects had got
Yusuf Jamal, Department of Physiology in Ayurvedic and grade I, 50% of the subjects had got grade II, and 17%
Global Journal of Medical Research Volume XII Issue XI Version I

Unani Tibbia College & Hospital to evaluate the efficacy of the subjects got grade III improvement respectively.
of a Unani formulation named Tila e Hadaf in the This shows majority of the cases had got grade II and
management of erectile dysfunction. The results of the were having satisfactory improvement.
study revealed that: The present study reveals that overall effect of
Majority of the married males (30.00%) were Tila e Hadaf was found quite encouraging in the
between the age group of 26-30 years, 23.00% were in treatment of erectile dysfunction and significant
age group between 21-25 years, 29.00% were between improvement was observed in subjective parameters.
the age group of 31-35 years and only 19.00% were in No clinically significant side effects were observed in
the age group of more than 36 year. Thus it is seen test group and overall compliance to the treatment was
most of the married males participated in the study were found excellent. These results conclude that the test
below 50 years of age. drug Tila e Hadaf is a cheap, safe, and effective
The present study shows that in educational treatment for erectile dysfunctions.
status majority of married males (31.00%) had studied
up to secondary, 28% had primary education, 24% had
References Références Referencias
higher secondary education and 17% had graduate and 1. Impotence. NIH Consensus Statement. 1992 Dec 7-
above educational qualification. This shows that majority 9; 10(4):1-33.
of participants were having secondary education. 2. Feldman HA, et al. Impotence and its medical and
The present study reveals that majority of psychosocial correlates: results of the
married males 32% were unemployed, 25% were skilled, Massachusetts Male Aging Study. J Urol 1994;
19% were semiskilled, and 24% were unskilled worker 151(1):54-61.
respectively. Thus it is seen that most of the married 3. Ayta IA, McKinlay JB, Krane RJ. The likely worldwide
males had an occupation. increase inerectile dysfunction between 1995 and
The present study shows that out of total 100 2025 and some possible policy consequences. BJU
married males in the study 25% were from upper middle Int. 1999 Jul; 84(1):50-6.
(2) SES, 45% were from lower middle (3) SES, and 30% 4. Kongkanand A. Prevalence of erectile dysfunction in
were from upper lower (4) SES. Maximum numbers, 45 Thailand. Int. J Androl 2000; 23 Suppl 2:77-80.
(45.00%) were from lower middle (3) SES. This can be 5. Spector IP, Carey MP. Incidence and prevalence of
attributed to lower educational and occupational status the sexual dysfunctions: A critical review of the
of subjects. empirical literature. Arch. Sex. Behav. 1990;
The present study reveals that 60% of the 19(4):389–408.
subjects were from Hindu community, 36% subjects 6. www.hsph.harvard.edu/hpfs access online on dated
were from Muslim community and 4% from other 25th Nov 2012.
communities.. This shows that majority of the subjects 7. Johannes CB, Araujo AB, Feldman HA, et al:
were from Hindu community. Incidence of erectile dysfunction in men 40 to 69
The present study depicts that 55% of the years old: Longitudinal results from the
subjects were fromo nuclear family and 45% were from Massachusetts Male Aging Study. J Urol
joint family. Hence it is clear majority of the subjects 2000;163:460-463.
participating in the study were from nuclear family. 8. Laumann EO, Paik A, Rosen RC: Sexual dysfunction
© 2012 Global Journals Inc. (US)
 To Evaluate the Clinical Efficacy of Tila E Hadaf in the Management of Erectile Dysfunction

in the United States: Prevalence and predictors.

JAMA 1999; 281:537-544.
9. Nobel, Park S. (2002). Cacti: biology and uses.
Berkeley: University of California Press.
10. Tajuddin , Ahmad S, Latif A, Qasmi IA. Effect of 50%
ethanolic extract of Syzygium aromaticum (L.) Merr.
& Perry. (clove) on sexual behaviour of normal male
rats. BMC Complement Altern Med. 2004.
11. Guerrero RD III. 2009. Vermicompost and
Vermimeal Production. MARID Agribusiness
Technology Guide. P-22 .
12. Müller-Schwarze, D and Houlihan, P.W.,
"Pheromonal activity of single castoreum

Year 2012
constituents in beaver,Castor canadensis", Journal
of Chemical Ecology, Volume 17, Number 4: 1991,
Springer Netherlands.
61

Global Journal of Medical Research Volume XII Issue XI Version I

© 2012 Global Journals Inc. (US)

Global Journals Inc. (US) Guidelines Handbook 2013

www.GlobalJournals.org