Treatment of Salas-ul-Baul (Stress Urinary Incontinence) with Unani medicine Kundri

Phase 3

Not yet recruiting

• Conditions: Stress incontinence (female) (male),

• Registration Number: CTRI/2021/06/034371
• Lead Sponsor: Central Council for Research in Unani Medicine CCRUM New Delhi

Brief Summary

This study is designed as a multicentric open trial in patients with **Salas-ul-Baul (Stress Urinary Incontinence).** After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be treated with Unani pharmacopoeial formulation **Kundri 6gm twice** twelve weeks.  The patients will be assessed at every two weeks. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be twelve weeks. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.

**Composition of** ***Kundri***

| | | | |

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

|**S. No.**

**Ingredients**

**Botanical/English name**

**Quantity**

|1

KunjadSiyahMuqash-shar

Sesamum indicum

1250gm

|2

Murmakki

Commiphoramyrrha

50gm

|3

Kundur

Boswellia serrata Roxb.

50gm

|4

Aqaqya

Acacia arabica

50gm

|5

Amla Khushk

Phyllanthus emblicaLinn.

50gm

|6.

PhitkariBiryan

Alum

70gm

|7.

Tukhm-e-Khatmi

Althae officinalis Linn.

240gm

|8

Zanjabeel

Zingiber officinale

240gm

|9

Post Halela

Terminalia chebulaRetz.

240gm

|10

Qandsafaid

Sugar

4.75kg

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2021-06-22
• Study Start: 2021-06-30

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

• Subjects of either sex between the age group of 40 to 70 years 2.
• Involuntarily dribbling of urine (Even small drops) 3.
• Involuntary leakage of urine triggered by coughing, sneezing, laughing, bending, lifting or exercising.

Exclusion Criteria

• Pregnant women.
• Obese/Fatty abdomen.
• Prolapsed disc and dislocated vertebrae.
• Subjects with Renal/Urinary Bladder Calculi 5.
• Known cases of Diabetes Mellitus, Parkinson’s and multiple sclerosis 6.
• Other systemic illness requiring long term treatment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in signs and symptoms of Salas-ul-Baul (Stress Urinary Incontinence)	The patient will be assessed at every 2 weeks. The total duration is 12weeks

Secondary Outcome Measures

Name	Time	Method
Haematological and biochemical assessment for safety assessment	At every 2 weeks till 12 weeks

Trial Locations

Locations (2)

Clinical Research Unit, Meerut; 🇮🇳 Meerut, UTTAR PRADESH, India

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

Clinical Research Unit, Meerut

🇮🇳Meerut, UTTAR PRADESH, India

Dr Mohd Naseem

Principal investigator

8451934661

naseemrrium786@gmail.com