To evaluate the Safety and efficacy of two Unani formulations in the treatment of Leucorrhoea

Phase 2

Recruiting

• Conditions: Trichomoniasis, unspecified, (2) ICD-10 Condition: A599||Trichomoniasis, unspecified,

• Registration Number: CTRI/2015/02/005562
• Lead Sponsor: Central Council for Research in Unani Medicine

Brief Summary

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|This study is designed as a multicentric open trial in patients with **Sailan-ur-Reham(Leucorrhoea)** After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria.  The patients will be assessed clinically after every two weeks.  This includes subjective assessment of general well being and physical examination . The total duration of treatment will be 04 weeks. . Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.

COMPOSITION OF HABB E MARWAREED

1.     Mastagi                                                                                                         120g

2.     Tinkar Neem Biryaan                                                                                60g

3.     Mazu Moharraq                                                                                         60g

4.     Azaraqi Mudabbar                                                                                                60g

5.     Marwareed                                                                                                  15g

6.     Ambar Ashhab                                                                                            15g

7.     Arq e Gulab                                                                                                  Q.S

**COMPOSITION OF Qurs Kushta Khubs al Hadeed**

Khabs ul Hadeed                                                                     100g

Chaach                                                                                    Q.S.

Sirka Naishkar                                                                        Q.S

Maghz e Gheekwar                                                                 Q.S

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02-04
• Last Update Posted: 2019-02-21

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

• •Female patients in the age group of 13-45 years.
• •Patients having excessive white discharge with or without any of the following associated symptoms Backache General Weakness Anaemia.

Exclusion Criteria

• •Patients having acute/acute on chronic/Chronic PIDs as per Hegards Criteria (Annexure-IV) •Patients on long-term medications.
• •Patients on Oral Contraceptives/IUDs. •Patients taking hormonal therapy.
• •Any abnormal condition on p/s Examination.
• •Pregnant and lactating women.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in signs and symptoms	4 weeks

Secondary Outcome Measures

Name	Time	Method
Hematological and biochemical assessments for safety	4 weeks

Trial Locations

Locations (4)

Central Research Institute of Unani Medicine (CRIUM), Lucknow; 🇮🇳 Lucknow, UTTAR PRADESH, India

Regional Research Institute of Unani Medicine (RRIUM), Aligarh; 🇮🇳 Aligarh, UTTAR PRADESH, India

Regional Research Institute of Unani Medicine (RRIUM), New Delhi; 🇮🇳 South, DELHI, India

Regional Research Institute of Unani Medicine (RRIUM), Patna; 🇮🇳 Patna, BIHAR, India

Central Research Institute of Unani Medicine (CRIUM), Lucknow

🇮🇳Lucknow, UTTAR PRADESH, India

DR S M QASIM

Principal investigator

05222361720

crium_lko@yahoo.co.in