Erandamuladi Niruha Basti and Madhutailik Basti in the Management of Polycistic Ovarian Syndrome in the Reproductive age women.

Phase 3

Not yet recruiting

• Conditions: Polycystic ovarian syndrome. Ayurveda Condition: POLYCYSTIC OVARIAN SYNDROME, (2) ICD-10 Condition: E282||Polycystic ovarian syndrome,

• Registration Number: CTRI/2023/05/052924
• Lead Sponsor: SANDHYA MADHUKAR YENNAWAR

Brief Summary

The polycystic ovarian syndrome is a common endocrine disorder affecting women in their reproductive age group with a 6-10% prevalence rate. It was first described by Stein and Leventhal in 1935, called Stein and Leventhal syndrome. It is characterised by a combination of hyperandrogenism either clinical or biochemical, chronic anovulation and polycystic ovaries. It is frequently associated with insulin resistance and obesity. It is the best known and most extensively studied cause of an ovulatory infertility in the reproductive age women.



The conditions which are mentioned in various contexts in ayurvedic classics under various headings as Artavkshaya, Anartava, Nastrartava, Vyandyayonivyapad, PushpaghniJataharini, ShushkarevatiJataharini, Sthoulya, Prameha, Strotodushti, and Santarpannothavyadhi can be to some extent compared with the symptoms of PCOS which needs to be analysed as per ayurvedic parlance.

According to Ayurveda PCOS is the condition of “Bahudoshadushyaavasthaâ€. When there is bahudoshadushyaavastha symptoms are multiple. So, the treatment includes shodhana (bio-purification) chikitsa which is the main concern of Ayurveda to eradicate the disease and long lasting basis by striking at the root of disease (pathology).



According to Charaka, vata is the main causative factor in the manifestations of all types of yoniroga, so it should be treated first by shodhanachikitsa. Basti karma is considered as the main shodhanachikitsa. Basti is the multi- dimensional treatment procedure offering wide range of clinical benefits in different diseases. This extra ordinary therapeutic action is possible due to “Nanavidha dravya sanyogyatâ€. According to Sushruta, basti is effective in divergent fields of medicine like infection, immunological, auto-immune, degenerative, infertility, metabolic, endocrine and neurological diseases. Basti exerts action in the shakhagata, koshthagata, tiryagata, aavranjanyarogas and equally effective in bahudoshaavastha. Basti is ashukaari in action for eg., Niruhabasti takes only few minutes to act while vamana and virechana take few hours as basti is directly administered in the main seat of vata. So, it is known as “Upakramanam Sarvesham Sagraneeâ€. So, most of the drugs in Erandamuladiniruhabasti are Katu, Kashaya, Tiktarasatmaka, sukshma, tikshnagunatmaka, ushnaviryatmaka, katuvipaki. As well as deepaniya, pachaniya, anulomana, kapha vatahara, agnigunavardhaka, aartavjanan, medohara, shothahara, pramehaghna, kushthaghna, vrushya, granthivilayana in properties this will be beneficial in sampraptivighatana of PCOS. Hence, a prompt attempt is made to study the effect of shodhanachikitsa in PCOS i.e. Erandmuladi Niruha Basti and Madhutailik Basti in this research study.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-05-16
• Study Start: 2023-06-29

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 140

Inclusion Criteria

• Diagnosed cases ofPCOS (by Rotterdam criteria)- Any 2/3.
• Hyperandrogenism (Clinical or biochemical).
• Oligomenorrhea (menstrual cycle >35 days)/ Secondary amenorrhea (menstrual cycle >90 days but < 180 days).
• USG findings- PCO features on USG i.e. peripherally Arranged Antral Follicle Count >12 with thickened stroma in ovaries and/or Ovarian volume >10 cm 3 in Unilateral or Bilateral ovaries.
• Patient fit for basti.

Exclusion Criteria

• Patient of age group <18 and >35years.
• Patients showing sign & symptoms other than PCOS.
• Patient having any other disease causing oligomenorrhea and anovulation excluding PCOS on above criteria i.e.Hypogonadotrophic hypogonadism, premature ovarian failure.
• Known cases of a) Congenital adrenal hyperplasia b) Severe insulin resistance (insulin dependent diabetes mellitus) c) Androgen secreting ovarian and adrenal tumors d) Thyroid abnormalities e) Cushing syndrome f) Cardiac disease g) Hyperprolactinemia.
• Patient with any organic lesions of reproductive tract like TB, CA, Congenital anomalies, any other pelvic pathologies.
• A current or previous (within 3 months) use of OC Pills, glucocorticoids, antiandrogens, antidiabetics, anti-obesity drugs or any hormonal therapy.
• Pregnant patients.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Follicular growth (Ovulation)	Baseline - 4 weeks, 8 weeks and 12 weeks

Secondary Outcome Measures

Name	Time	Method
Hirsutism, Acne, Obesity (BMI), Hormonal estimation	Baseline - 4 weeks, 8 weeks and 12 weeks

Trial Locations

Locations (1)

Chatrapati Shahu Maharaj Shikshan Sansthas Ayurved Mahavidalaya and Rugnalaya; 🇮🇳 Aurangabad, MAHARASHTRA, India

Chatrapati Shahu Maharaj Shikshan Sansthas Ayurved Mahavidalaya and Rugnalaya

🇮🇳Aurangabad, MAHARASHTRA, India

Dr SANDHYA MADHUKAR YENNAWAR

Principal investigator

9850562524

dryennawar11@gmail.com