A trial drug for Polycystic Ovarian disease

Phase 2

Completed

• Conditions: Irregular Menstrual cycles

• Registration Number: CTRI/2014/06/004709
• Lead Sponsor: National Institute of Siddha

Brief Summary

This is a single arm open clinical trial to find out the therapeutic effect of Karpagandhi ennai (Internal). The trial drug is a combination of herbomineral drugs from the Siddha Text book Anubhava Siddha Vaidhya Muraigal (Author Balaraamayya )for the namagement of Sinaipaineerkatti (PCOS) in women. The constituents of the trial drug are Gandhagam (Sulphur), Poondu (Allium sativum), Gingelly oil (Seasamum indicum).  The internal drug will be issued in oil form at a dosage of 5 drops once a day with half-baked egg yolk for 10 days thereafter the drug will be stopped for next 10 days and restarted for 10 days.  Likewise drug will be given for 30 days for a patient. The clinical assessment and laboratory investigations will be recorded before and after the treatment period.  All the trial related data will be recorded, analysed statistically and the research reports will be published.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07-14
• Last Update Posted: 2015-10-19

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 10

Inclusion Criteria

• •Irregular menstrual cycle: Eight or fewer menstrual cycles in the past year or intermenstrual periods of 45 days or longer.
• •Patients having polycystic ovary on ultrasound should either have 12 or more follicles measuring 2-9 mm in diameter, or have an increased ovarian volume of 10 CC or greater •Patient willing for Ultrasound abdomen and blood investigations.
• •Patient willing to sign the informed consent.

Exclusion Criteria

• •Presence of any pelvic pathology such as chronic pelvic infection, Pelvic endometriosis, Adenomyosis, Uterine fibroid, Endometrial Polyp.
• •Presence of secondary endocrine disorder such as hyperprolactinaemia, thyroid dysfunction.
• •Patient using oral contraceptives or use of fertility drugs within 6 months •Presence of any associated severe systemic illness.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
•Normal appearing of ovary confirmed by TV USG or Confirming of normal follicles being formed and ruptured through folliculogram.	6-9 months
•Establishing regularization of menstrual cycle.	6-9 months

Secondary Outcome Measures

Name	Time	Method
•Enhancing weight reduction with a BMI 30.	•Reducing elevated hormone levels like testosterone and DHEAS.

Trial Locations

Locations (1)

National Institute of Siddha; 🇮🇳 Chennai, TAMIL NADU, India

National Institute of Siddha

🇮🇳Chennai, TAMIL NADU, India

SKeerthana

Principal investigator

9962927684

sk.keerthana@gmail.com