Effects of Unani formulation Safoof e Sailan in SayalÄn al-Rahim (Leucorrhoea)

Phase 2

Recruiting

• Conditions: Noninflammatory disorder of vagina, unspecified,

• Registration Number: CTRI/2018/10/016168
• Lead Sponsor: Central Council for Research in Unani Medicine

Brief Summary

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



Composition of **Safoof e Sailan**

| | | |

| --- | --- | --- |

|**S. No.**

**Ingredients**

**Quantity**

|1.

Gul e Dhawa

15g

|2.

Gul e fofil

15g

|3.

Mochras

15g

|4.

Samagh e Mulsari

15g

|5.

Qand e Safaid

60 g

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-15
• Last Update Posted: 2019-02-21

Recruitment & Eligibility

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

Inclusion Criteria

• 1.Female patients in the age group of 13-45 years.
• 2.Patients having excessive white discharge with or without any of the following associated symptoms 3.Waja‘ al-Zahr (Backache) 4.Naqahat (General Weakness).

Exclusion Criteria

• 1.Patients having acute/ acute on chronic/Chronic PIDs (as per the CDC Diagnostic Criteria attached as an annexure-IV) 2.Patients with diseases requiring long-term treatment.
• 3.Patients on Oral Contraceptives/IUDs. 4.Patients taking hormonal therapy.
• 5.Any abnormal condition on p/s Examination.
• 6.Pregnant and lactating women.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in signs and symptoms of SayalÄn al-Rahim (Leucorrhoea)	2 weeks

Secondary Outcome Measures

Name	Time	Method
Haematological and biochemical assessment for safety assessment	At baseline and end oftreatment

Trial Locations

Locations (3)

Central Research Institute of Unani Medicine; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Clinical Research Unit; 🇮🇳 Kurnool, ANDHRA PRADESH, India

Regional Research Institute of Unani Medicine; 🇮🇳 Mumbai, MAHARASHTRA, India

Central Research Institute of Unani Medicine

🇮🇳Hyderabad, ANDHRA PRADESH, India

Dr Syeda Khadeerunnisa

Principal investigator

9397953137

syedakhadeerunnisa@criumhyderabad.net