A Clinical Trial to study the effect of the Drug Naaval nei in patients with high bleeding during menstruation

Phase 2

Recruiting

• Conditions: Pitha Perumbadu (Menorrhagia)

• Registration Number: CTRI/2017/05/008615
• Lead Sponsor: Govt Siddha Medical College

Brief Summary

This is a single arm open clinical trial to study the safety and efficacy of Siddha trial drug Naaval nei. The trial drug is given 5 ml twice a day for 48 days. Clinical trial is conducted after conducting Preclinical toxicity study. The trial drug Naaval nei is mentioned in aathmaratchamirtha Vaithiya Saara Sangiragam. During the trial all the study related data will be recorded and documented. After the completion of trial all the data will be analysed statistically.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-26
• Last Update Posted: 2017-03-28

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

Patients with the following signs and symptoms Excessive menstruation Prolonged menstruation Presence of Blodd clots in menstrual bleeding Lower abdominal pain Low back ache Triedness during menstruation Giddiness during menstruation Head ache durring menstruation USG report with Fibroid uterus or PCOD or Ovarian cyst.

Exclusion Criteria

Pelvic pathology Diabetes mellitus Hypertension Patients having IUCD Abortion Thrombocytopenic purpura Coagulopathy Severe Anemia (<6 gm) Hypothyroidism Vulnerable population such as HIV and TB affected individuals.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Outcome is mainly assessed by reduction in clinical symptoms and by comparing the following parameters before and after treatment.	48 days
Reduced amount of blood flow is assessed by bleeding time, clotting time And Haemoglobin	48 days

Trial Locations

Locations (1)

Arignar Anna Government Hospital of Indian Medicine; 🇮🇳 Chennai, TAMIL NADU, India

Arignar Anna Government Hospital of Indian Medicine

🇮🇳Chennai, TAMIL NADU, India

Dr S Jayapriya

Principal investigator

9894529964

jpsubi2009@gmail.com