Egyptian Herbal Monograph

Volume 1

Traditional wild medicinal plants

Egyptian Drug Authority (EDA)

2024
 Egyptian Herbal
Egyptian Herbal Monograph
Monograph

Egyptian Herbal Monograph

Traditional wild medicinal plants
Withania somnifera (L.) Dunal ‫سم فراخ‬
1. Names & Synonyms (1-4)
Withania somnifera (L.) Dunal

Syns.: Alicabon somniferum (L.) Raf., Physalis somnifera L., Physaloides somnifera (L.) Moench.

Family: Solanaceae

Arabic: Sem Ferakh ‫سم فراخ‬

English name: Ashwagandha, Winter-cherry.

2. Geographical distribution (4)

- The Nile region, Mediterranean coastal strip as well as all the deserts of the country
including that of Sinai.

3. Parts used for medicinal purpose

- Dried roots (5-8).

4. Major chemical constituents (9)

- Steroidal lactones: Withanolides (as withaferin A, B, D) (10, 11).

- Alkaloids (12): Withanine, somniferine, somnine, withanmine, pseudowithamine, and
withanaminine (13), tropine, choline, pseudotropine, dl-isopelletierine, cuscohygrine,
anahygrine,and anaferine (14).
- Others: terpenoids, saponins, phenolics, flavonoids, phytophenols, and glycosides.

5. Traditional Medicinal Uses (5-8)

A. As a sleep aid

B. Memory enhancement

C. An adaptogen to help increase energy and resistance to stress (e.g., in case of mental
and physical fatigue related to stress.
W. somnifera is a traditional medicinal plant for use in the specified indications based exclusively
upon long-standing use.
 Egyptian Herbal Monograph

6. Herbal preparations correlated to medicinal use (5,6)

1. Comminuted herbal substances are added to water as herbal tea in the form of decoction or
infusion.

2. Powdered drug

3. Ethanolic extracts (dry extract, fluid extract, tincture)

Herbal preparations (2-3) are in pharmaceutical dosage forms. The pharmaceutical form
should be described by the pharmacopoeia full standard term.

7. Posology and method of administration correlated to medicinal use

(5-7)
Preparations 1 - 3
Indications A and B
Adults and elderly: 2 - 6 g daily of the dried root or equivalent preparations.

Preparation 2
Indication C
Adults and elderly: 2.5-6.5 g daily of the dried root or equivalent preparations (5,8,15,16).
Powdered crude drug: 3–6 g of the dried powdered root (8).

Preparation 3
Adults and elderly:
- 250 mg, twice daily (8).
- 300 - 500 mg of an extract standardized to contain 1.5 % withanolides (15).
- 6 - 12 ml of a 1:2 fluid extract, daily (15).

Duration of use
- If the symptoms persist longer than 4 weeks (for indication A (5)) and 3 months (for
indications B and C (6)) during the use of the medicinal product, a doctor or a pharmacist
should be consulted.

Method of administration: Oral use (5).

8. Contraindications
- Hypersensitivity to the active substances and to other plants of the same family.
- Due to its immunomodulatory effects, it has been suggested that Ashwagandha should be
avoided in autoimmune diseases such as lupus and multiple sclerosis (7).
 Egyptian Herbal Monograph

9. Special warnings and precautions for use

- If the symptoms worsen during the use of the medicinal product, a doctor or a pharmacist
should be consulted.
- Use with caution in peptic ulcer; Ashwagandha may cause gastrointestinal irritation (6).
- The use is not recommended in patients below 18 years of age due to insufficient data on
safety (5, 7).

10. Interactions with other medicinal products and other forms of

interaction
- Avoid taking with alcohol or products that cause drowsiness (5).

- The crude drug may potentiate the effects of barbiturates and reduce the effects of
diazepam and clonazepam (8,16).

- There is limited evidence to suggest that it may increase thyroid hormone levels and may
therefore interfere in control of hypo- and hyperthyroidism (7).

11. Fertility, pregnancy and lactation

- Use during pregnancy is contraindicated (8,16) due to a reputed abortifacient activity (6).

- Use during breastfeeding is contraindicated (8).

- No fertility data available (8).

12. Effects on ability to drive and use machines (5)

- May impair ability to drive and use machines. Affected patients should not drive, operate
machinery or be involved in activities requiring mental alertness.

13. Undesirable effects

- If adverse reactions occur, a doctor or a pharmacist should be consulted.

- Some people may experience drowsiness (5).

- May cause nausea, vomiting and diarrhoea (8).

14. Overdose
- Irritation to mucous and serous membranes resulting gastrointestinal upset, diarrhoea
and vomiting (6,16).

15. Relevant biological activities

Treatment of sleep disorders

- Administration of Ashwagandha root extract to patients for 10 weeks (300 mg of the

extract was administered twice daily) significantly improved the quality of sleep and also
made it easier and faster to fall asleep (17).
 Egyptian Herbal Monograph

- Studies have been conducted in older people aged 65–80 years to assess the safety, efficacy
and tolerability of Ashwagandha root extract. The tested treatment was found to be safe
and effective, and the participants showed good tolerance (18).

- A group of healthy individuals exhibiting symptoms of non-restorative sleep (NRS) were

administered 120 mg of standardised ashwagandha extract once daily for 6 weeks. It was
observed that 72% of the subjects improved their sleep quality compared to 29% in the
placebo group. There was a significant improvement in sleep duration and total sleep time,
as well as an improvement in WASO (wake after sleep onset). Significant improvements in
physical, psychological, and environmental areas were also noted. No treatment-related
side effects were reported throughout the course of the study (19).

- A number of studies showed that Ashwagandha significantly impacts the deterioration of

mood and cognitive and motor functions. It occurs when insufficient sleep leads to reduced
efficiency, impaired alertness and a deterioration in overall health (20-22).

- The effect of Withania somnifera extract was conducted on adult male rats where the
animals were subjected to sleep deprivation for one week and indicators of oxidative stress
were measured. A reduction in antioxidant enzyme levels was observed in the sleep-
deprived rat group. A significant reduction in the levels of free radicals and lipid
peroxidation and an increase in the levels of antioxidant enzymes were observed in the
group treated. Levels of dopamine and serotonin also increased compared to the untreated
control group. It can therefore be concluded that Withania somnifera is an effective
therapeutic agent for the treatment of sleep deprivation (23).

Anxiolytic and anti-stress effects

- A study was conducted on a group of patients diagnosed with Generalized Anxiety Disorder
(GAD). Participants were treated with Selective Serotonin Reuptake Inhibitors (SSRIs) and
also took one capsule of Ashwagandha extract daily for six weeks. After the experiment, it
was concluded that Withania somnifera extract could potentially support SSRI therapy in
patients diagnosed with GAD syndrome (24).

- Ashwagandha supplementation statistically and significantly reduced Hamilton Anxiety

Rating Scale (HAM-A) and to a slightly lesser extent, reduced Depression, Anxiety and
Stress Scale (DASS-21). A reduction in morning cortisol and DHEA-S levels was also
observed. A significant reduction in perceived stress scale (PSS) scores was observed (25-
27).

- A study was conducted using a sustained-release capsule containing Ashwagandha root

extract (300mg). Participants took one Ashwagandha capsule daily for 90 consecutive days.
It was noted that treatment with Withania somnifera once daily with one capsule
significantly improved memory and attention, sleep quality and overall psychological well-
being. A reduction in stress levels was also noted. The treatment appeared to be safe and
well tolerated (28).

- A group of patients with schizophrenia, depression and anxiety disorders were treated
with standardised Withania somnifera extract. The results of the study suggested that the
 Egyptian Herbal Monograph

extract had promising effects in the treatment of patients with depression, anxiety
disorders and schizophrenia (29).

- Administration of the plant extract to patients resulted in a reduction in negative, general,

and total Positive and Negative Syndrome Scale (PANSS) symptoms compared to placebo.
There was a significant improvement in Perceived Stress Scale (PPS) scores. These
significant improvements were noted in the study group, and they experienced only
minimal side effects (30).

Adaptogenic Effect

- A study was conducted on a group of horses given Ashwagandha root extract. The animals
were subjected to various stressors, such as heavy exercise, separation and noise.
Haematological, biochemical, hormonal, and immunological parameters were studied
during the experiment. After 21 days, a statistically significant decrease in cortisol,
epinephrine, glucose, triglycerides, creatinine, IL-6, alanine aminotransferase and aspartate
aminotransferase were observed in the treated group. This indicates the adaptogenic,
antioxidant and immunostimulating effects of Ashwagandha (31).

- The adaptogenic effects of the standardised extract was studied in rats subjected to chronic
stress (CS) using the Footshock method. Chronic stress induced the induction of
hyperglycaemia, glucose intolerance, elevated plasma corticosterone levels, increased
gastric ulcers, sexual dysfunction, cognitive deficits, immunosuppression, and mental
depression. The entire range of the disorders was significantly alleviated by the
administration of the extract prior to the stressor (32).

- The effect of an aqueous fraction devoid of withanolides, which was isolated from the root
of Ashwagandha, was studied. The study investigated the adaptogenic activity of
withanolide-free aqueous fraction from the roots in rats and found that it exhibited
significant anti-stress effects, including improved swimming endurance and reduced
adrenal gland weight, without causing any adverse effects (33).

- A double-blind, placebo-controlled clinical trial assessed the effects of the root (250 mg
twice daily) on psychomotor performance in 30 healthy volunteers. The effects were
compared with those of Panax ginseng (100 mg twice daily). Test parameters included
tapping, cancellation test, mental mathematical calculations, logical deductions, choice
reaction times and auditory reactions. The performance of both groups was superior to
that of subjects who received a placebo and the performance of subjects given the crude
drug was superior to that of those given Panax ginseng after 40 days of treatment (34).

16. Additional Information

-

17. Date of compilation/last revision

13/11/2023.
 Egyptian Herbal Monograph

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