MANAGEMENT OF ARTAVA DUSHTI W.S.R TO POLYCYSTIC OVARIAN SYNDROME WITH AROGYAVARDHINI RASA AND PATHADI CHOORNA.

Phase 3

Not yet recruiting

Conditions: Polycystic ovarian syndrome. Ayurveda Condition: ARTAVADUSHTI,

Registration Number: CTRI/2021/02/030954

Lead Sponsor: IPGT AND RA

Brief Summary: The study comprises a clinical trial for the management of *Artavadushti* w.s.r to Polycystic Ovarian Syndrome with *Arogyavardhini Rasa* and *Pathadi choorna* .Polycystic ovarian syndrome is a heterogenous multisystem endocrinological disorder in women of reproductive age with ovarian expression of various metabolic disturbances and wide spectrum of clinical features such as obesity, menstrual abnormalities and hyperandrogenism. Women often initiate treatments for a cluster of symptoms like menstrual irregularities, obesity, hirsutism. But the most concerning medical consequences include, Infertility, Diabetes mellitus, Endometrial carcinoma, Hypertension, Cardiovascular disease. No permanent effective treatment is found for PCOS in modern therapy except some sort of OCP, Metformin etc and for ovulation induction drugs like Letrozole are used along with symptomatic management. Moreover, it may fail in preventing the long-term consequences of PCOS. Ayurvedaprovides ample of medicines and treatment protocol under the concept of *Ashta Artava Duhsti.*Main objectives of this study is to evaluate the effect of trial drugs *Arogyavardhini**Rasa* and *Pathadi Choorna* in the management of PCOS and efficacy on ovulation and conception . Here 60 diagnosed patients of PCOS as per Rotterdam revised criteria 2004 will be registered.Patients administerded with *Arogyavardhini Rasa* 250mg and *Pathadi Choorna* 5gm along with water on empty stomach both morning and evening for a period of 3 months . After that there will be a followup for1 month. A specific scoring pattern will develop based on clinical featuresof PCOS and the assessment will be done on the basis of both subjective & objective parameters.All the outcomes will be noted and appropriate statistical test applied to find the effect.Â·

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Female

Target Recruitment: 60

Inclusion Criteria

Both married /unmarried patients in the age group of 18-40yrs.
Patients with any 3 or more clinical features of PCOS like- Amenorrhea or Oligomenorrhoea Anovulation Infertility (Due to anovulation) Acne Hirsutism (Ferriman-Gallwey scale) Obesity (BMI above 25) Acanthosis nigricans Along with confirmation of any one Polycystic Ovary in USG finding.

Exclusion Criteria

1.Patients suffering from Pelvic/Systemic diseases like (Endometriosis, Hydrosalpinx, Fibroid uterus,).
2.Organic lesions of reproductive tract like T.B, Carcinoma and Congenital deformities.
3.Patients with history of Cardiac diseases, Chronic liver disease.
4.Age group <18yrs and > 40yrs will be excluded.
5.Uncontrolled Hypertension (Systolic BP above 150 & Diastolic above100mmhg), Uncontrol led Diabetes mellitus (above the range of 160-200 mg/dl, FBS).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
It is expected that trial drug help to improve anovulation ,oligoovulation ,hirsutism ,amenorrhea ,acne ,infertility, obesity	4 weeks after completion of clinical trial.

Secondary Outcome Measures

Name	Time	Method
Drug may have effect on ovulation induction and conception.	After the followup period.

Trial Locations

Locations (1): PG Hospital Ipgt and ra
🇮🇳
Jamnagar, GUJARAT, India
PG Hospital Ipgt and ra
🇮🇳Jamnagar, GUJARAT, India
Prof Laxmipriya dei
Principal investigator
9228198366
deilaxmipriya@yahoo.com