Clinical Study To Assess The Efficacy of Ayurvedic Formulations In PCOS

Phase 2

Not yet recruiting

Conditions: Follicular cyst of ovary,

Registration Number: CTRI/2020/07/026410

Lead Sponsor: National Institute of Ayurveda Jaipur

Brief Summary: Polycystic ovarian syndrome (PCOS) is a most prevalent endocrinopathy. It is common metabolic-endocrine-reproductive disorder. It leads to menstrual irregularities ranging from amenorrhea to dysfunctional uterine bleeding, hirsutism, acne, anovulation and sub fertility. Incidence of this disease is increasing now a days because of sedentary lifestyles, pollution and excessive intake of junk food. Diagnosis of PCOS is based on the presence of any two of the three criteria (ASRM/ESHRE, 2003) â€“ (1) Oligo and or anovulation (2) Hyperandrogenism (clinical and /or biochemical) (3) Polycystic ovaries.

As per Ayurveda this condition is not explained as a single disease entity, but given under the headings Yonivyapada (genital disorders), Artava Dushti (menstrual disorders), Pushpaghni Jataharini etc. Ayurvedic management is beneficial in controlling the three aggravated Doshas & brings balance & strength to the reproductive system& it helps to regulate Artava Dhatu. In view of this, Shatapushpa Churna and Madhutailika Basti are selected as trial drugs so as to provide an easy and cost effective therapeutic measure for PCOS. 30 patients suffering from Nashtartava (PCOS) from OPD & IPD National Institute ofAyurveda, Jaipur will be selected according to the inclusion criteria ,irrespective of religion, occupation and socio-economic status. Patients willbe randomly divided into two groups. In group A Shatapushpa Churna orally with Ghrita and group B Madhutailika Basti per rectum.

Shatapushpa Churna will be given 6gm orally with Ghrita twice a day for a period of 90 days or 3 consecutive cycles.

Madhutailika Basti 400mL per rectum empty stomach as following-

For irregular cycles- For 7days (after initial screening), then there is a waiting period of fifteen days, during which the patient may get her periods. The next seven days of medicine is started seven days prior to the expected date of next menstruation, in case she does not get her periods, medicine again started for seven days, after the waiting period, this follows for three cycles of medicine administration.

For regular cycles- Seven days prior to the expected date of menstruation for three consecutive cycles.

During trial, follow up will be done after completion of one menstrual cycle. After completion of the trial, case will be followed after one month. Assessmentwill be done on the basis of objective and subjective parameter beforetreatment, after treatment, and during last follow up. Appropriate statisticaltest will be applied.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Female

Target Recruitment: 30

Inclusion Criteria

Patients willing to give voluntary informed consent.
Both married and unmarried patients.
ASRM/ESHRE (Rotterdam) Criteria,2013- Affected individuals must have two out of three criteria 1.
Oligo and /or anovulation 2.
Hyperandrogenism (clinical and /or biochemical).
Polycystic ovaries(Confirmed on USG).

Exclusion Criteria

Patients not willing to give voluntary informed consent.
Women of age <18years and >40years.
Patients with chronic systemic illness (Congestive cardiac failure, Hypertension, cirrhosis of liver, chronic renal disease, diabetes mellitus, Tuberculosis etc.).
Patients using oral contraceptive pills.
Patients with any organic reproductive system abnormalities (Excluded clinically and radiologically), pelvic inflammatory disease, hydrosalpinx, endometriosis, adenomyosis, fibroid uterus, carcinoma of reproductive organ.
Any type of malignancy.
Patients with positive Sexually transmitted diseases (STDs), Human Immunodeficiency Virus HIV, Hepatitis B Surface Antigen(HbsAg).
Patients suffering from adrenal hyperplasia, severe insulin resistance, androgen secreting neoplasm, thyroid abnormalities, Cushingâ€™s syndrome.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in features of oligomenorrhoea /anovulation.	3 months

Secondary Outcome Measures

Name	Time	Method
Changes in PCOS features (i.e. acne, hirsutism).	3 months

Trial Locations

Locations (1): National institute of Ayurveda
🇮🇳
Jaipur, RAJASTHAN, India
National institute of Ayurveda
🇮🇳Jaipur, RAJASTHAN, India
Dr Shalvi Sharma
Principal investigator
8988071274
shalvi0699@gmail.com