Comparative clinical study on the effectiveness of Ashwagandhadi transdermal gel and estrogen gel on the perimenopausal symptoms

Brief introduction-

Perimenopause refers to the time before, during and after permanent cessation of menstruation. The perimenopausal symptoms involve hot flashes, night sweats, vaginal itching, dryness of vagina, mood swings, decreased libido which are caused due to decrease in estrogen levels1. Hormone replacement therapy is indicated in perimenopausal woman to overcome the short term and long term consequences of oestrogen deficiency. Oestrogen when given orally undergoes ‘first pass’ metabolic effect in the gut and liver. Hence transdermal hormonal gels are desirable with high drug penetrating power. And most of the women found oral administration is difficult and inconvenient in fast going life, transdermal gel application is yielding much results. But the estrogen gel is having much adverse effects when compared with Ashwagandhadi transdermal gel, which is having no adverse effects.  The Ashwagandhadi transdermal gel comprises of 3 drugs- Ashwagandha, Shatavari and Mandooka parni. The presence of flavonoids in these drugs will help to improve oestrogen level. Mainly the withenin present in Ashwagandha, casticin- castilliferol present in Mandooka parni, luteolin in shatavari are proven to have highest phytoestrogen in them2. Hence the study is being undertaken.

Objectives –

**1.**To study the effectiveness of Ashwagandhadi transdermal gelin  reliving perimenopausal symptoms

**2.**To compare the trial group with control group applied with estrogen gel in relieving perimenopausal symptoms

Methodology –

Method of preparation - Ashwagandha*, Shatavari* and Mandooka parniwill be taken in equal proportion and the extracts will be extracted out separately using cold maceration technique. Then gel will be prepared by standard method of gel preparation by using carbopol as base and ashwagandha arka, shatavari arka, Mandooka parni arka as liquid media. To this base the extracts will be added and the gel will be prepared. Permitted preservatives (API) will be added to increase shelf life. Finally the Ashwagandadi transdermal gel will be packed in sterile tubes**.**

Intervention plan-

Trial group

Control group

|Treatment modalities

Application over the dry and cleaned both arms in the manner of outer arm from shoulder down

Application over the dry and cleaned both arms in the manner of outer arm from shoulder down

|Area of application

shoulder

shoulder

|Formulation

Ashwagandhadi transdermal gel

Estrogen gel

|Time

8 weeks

8 weeks

|Duration of application

Once in a day

Once in a day

1. Research design-

Open labeled double arm comparative clinical study

2. Source of data -

·         Literary data – literary data is collected from Ayurvedic Classical text, International journals, relevant research literatures, contemporary medical textbooks.

·         Clinical data- It is a clinical study where subjects fulfilling the diagnostic and inclusion criteria will be selected from out-patient department of PG studies in Prasuti tantra Evum stri roga of S.D.M. college of Ayurveda and hospital, Hassan. Proforma will be prepared with all points of history taking, physical signs.

 3. Sampling method- convenient sampling

 4. Sample size= N=20 subjects

5. Diagnostic criteria – diagnosis will be made on the basis of following symptoms of perimenopause

Major criteria-

·         Hot flashes or night sweats,

·         Fatigue, headache , irritability

Minor criteria-

·         With or without depression, vertigo, nervousness, Paresthesia, sexual complaints, urinary tract infections, , palpitations, formication,  arthralgia, myalgia, insomnia

 6. Inclusion criteria-

·         Age group – 40 to 55 years3

·         Fulfilling diagnostic criteria

 7. Exclusion criteria-

·         Any pre-existing psychological disorder

·          K/C/O uncontrolled diabetes mellitus, hypertension, thyroid dysfunction

8. Study duration – 2 months

9. Follow up study-

Once in 15 days during treatment

After a month after treatment

10. Assessment criteria

The patients will be assessed on the basis of improvement in the symptoms of perimenopause using Kuppermann’s menopausal scale

Criteria for assessment of overall effect -

Overall effect of the therapy will be assessed in terms of,

S.N.

Remission

Relief in chief complaints( in terms of percentage)

|1

Complete remission

100

|2

Marked remission

75-99

|3

Moderate remission

50-74

|4

Mild remission

25-49

 List of references –

1.      D.C. Dutta, Textbook of gynecology, editor - Konar H, 6th edition, 2013, jaypee brothers medical publishers (P).Ltd, 6th  chapter, p-57

2.      Powers, C.N., Setzer, W.N. A molecular docking study of phytochemical estrogen mimics from dietary herbal supplements. In Silico Pharmacol. 3, 4 (2015). [ springer] [ crossRef] [ Google scholar]

3.      Ahuja Maninder. Age of menopause and determinants of menopause age: a PAN India survey b IMS. 2016. Doi: 10.4103/0976-7800.191012 [PubMed] [Google scholar ].