Treatment of white discharge from vagina with Unani medicine Safoof Makhana

Phase 3

Not yet recruiting

• Conditions: Other specified noninflammatory disorders of vagina,

• Registration Number: CTRI/2024/07/071582
• Lead Sponsor: Central Council for Research in Unani Medicine CCRUM New Delhi

Brief Summary

This study is designed as a single centric 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 at every week for 28days. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be 28days. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.

***Composition of Safoof Makhana:***

| | | |

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

|S.No

Ingredients

Quantity

|1

Salab Misri

200g

|2

Tukhm-e-Talmakhana

200g

|3

Satawar

200g

|4

Ilaichi Khurd

200g

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2024-07-29
• Study Start: 2024-09-08

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 110

Inclusion Criteria

• Female patients in the age group of 14-45 years.
• Patients having excessive white discharge with or without any of the following associated symptoms a.
• Waja‘ al-Zahr (Backache) b.
• Naqahat (General Weakness) c.
• Burning Micturition d.
• Pruritus vulvae.

Exclusion Criteria

• Patients having acute/ acute on chronic/Chronic PIDs (as per the CDC Diagnostic Criteria attached as an annexure-V) 2.
• Patients with diseases requiring long-term treatment.
• Patients on Oral Contraceptives/IUDs. 4.
• 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
• Waja‘ al-Zahr (Backache)	At baseline, 7th day, 14th day and at the end of study i.e. 28days
• Naqahat (General Weakness)	At baseline, 7th day, 14th day and at the end of study i.e. 28days
• Burning Micturition	At baseline, 7th day, 14th day and at the end of study i.e. 28days
• Pruritus vulvae	At baseline, 7th day, 14th day and at the end of study i.e. 28days
The efficacy of the study drugs will be assessed on the basis of improvement in the following symptoms for which a 10-point Visual Analog Scale (VAS) will be applied.	At baseline, 7th day, 14th day and at the end of study i.e. 28days
• Amount of Vaginal Discharge (rated according to the number of pads used in a day)	At baseline, 7th day, 14th day and at the end of study i.e. 28days

Secondary Outcome Measures

Name	Time	Method
Haematological & biochemical assessment for safety assessment i.e. CBC, LFT, KFT, Urine Routine & microscopic examination.	At baseline and at the end of study i.e. 28days

Trial Locations

Locations (1)

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

Central Research Institute of Unani Medicine (CRIUM)

🇮🇳Lucknow, UTTAR PRADESH, India

Dr Bushra Sabir

Principal investigator

7503539832

dr.bushrasabir@gmail.com