Study to find Effects of Chandraprabha Vati(Ayurvedic Medicine) in Polycystic Ovarian Syndrome Characterised by Small cysts in ovary with irregular,Scanty menses and excess/unwanted hairs on Face,Thighs,Abdomen etc.

Phase 2/3

Not yet recruiting

• Conditions: Polycystic ovarian syndrome,

• Registration Number: CTRI/2020/11/028824
• Lead Sponsor: Niranjan Ashok Dumbare

Brief Summary

This is a randomize,Parallel group,Singleblind,Clinical trial with Active control i.e Standard Control,to study theSafety & Efficacy of Chandraprabha Vati(Ayurvedic Formulation in TabletForm) 500 mg twice daily for 6 months with Luke warm water just before food in70 patients with Polycystic Ovarian Syndrome which will have Active Controlgroup included Tablet Metformin Hydrochloride 500 mg thrice a day with waterjust before food in 70 Patients for 6 months in 2 centers in India.The Primaryoutcome 1) Menstrual History For Interval between 2 cycles 2)modified Ferriman Gallwey Score (Hirsutism) will be measures  At Enrollment & After 6 Months.

The Secondaryoutcome ,BMI IN KG/M2,Sr. Testesterone,Sr. Insulin (F),BSL(F),USG (Pelvis)TASOR TVS for 1)PCOS Pattern2)Ovarian volume, will be measures  At Enrollment & After 6 Months.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-02-11
• Study Start: 2020-11-16

Recruitment & Eligibility

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

Inclusion Criteria

• 1.Patients of age group 19-35 years.
• 2.Diagnosed cases of PCOS (Rotterdam Criteria) Any 2/3 a)Hyperandrogenism (Clinical or Biochemical) b)Oligomenorrhea (Menstrual cycle > 35days)/ Secondary Amenorrhea (Menstrual cycle > 90 days but<180 days) c) USG findings– PCO features on USG i.e. Peripherally arranged Antral Follicle Count >12 with thickened stroma in Ovaries And OR Ovarian Volume >10 cm3 in Unilateral or Bilateral ovaries.
• 3.Both Unmarried and Married patients of PCOS.

Exclusion Criteria

• 1.Patients of age group < 19 yrs and > 35 yrs.
• 2.Patients showing signs and symptoms other than PCOS.
• 3.Patients having any other disease causing Oligomenorrhea & Anovulation excluding PCOS on above criteria i.e.Hypogonadotrophic Hypogonadism, Premature Ovarian Failure.
• 4.Patients suffering from a) Congenital Adrenal Hyperplasia b) Severe Insulin resistance(Insulin dependant Diabetes Mellitus) c)Androgen secreting Ovarian & Adrenal tumors d)Thyroid abnormalities e) Cushing’s syndrome f)Cardiac disease g) Hyperprolactenemia 5.Patients with any organic lesions of Reproductive Tract like TB, Ca, Congenital anomalies, any other pelvic pathologies.
• 6.A current or previous (within 3 months) use of OC Pills, Glucocorticoids, Antiandrogens, Antidiabetics, Antiobesity drugs or any Hormonal Therapy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Menstrual History For Interval between 2 cycles. 2.modified Ferriman Gallwey Score for Hirsutism	At Enrollment and After 6 months

Secondary Outcome Measures

Name	Time	Method
BMI IN KG/M2	Sr.Testesterone Sr.Insulin (F) BSL(F)

Trial Locations

Locations (1)

CSMSS Ayurved Hospital; 🇮🇳 Aurangabad, MAHARASHTRA, India

CSMSS Ayurved Hospital

🇮🇳Aurangabad, MAHARASHTRA, India

Niranjan Ashok Dumbare

Principal investigator

9890201717

drniranjan417@gmail.com