| CTRI Number |
CTRI/2021/06/034371 [Registered on: 24/06/2021] Trial Registered Prospectively |
| Last Modified On: |
22/06/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment of Salas-ul-Baul (Stress Urinary Incontinence) with Unani medicine Kundri |
|
Scientific Title of Study
|
An open-label, Multicentric Clinical Validation Study to Evaluate the Efficacy and Safety of Unani Pharmacopoeial formulation – Kundri in Salas-ul-Baul (Stress Urinary Incontinence) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SB/SUI/KD/CLNVAL/CCRUM 2019-20, version 2 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Asim Ali Khan |
| Designation |
Director General |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room No. 502, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
01128525715 |
| Fax |
|
| Email |
unanimedicine@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naheed Parveen |
| Designation |
Assistant Director |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room No. 507, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
9213511298 |
| Fax |
|
| Email |
ccrum507@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep Kumar |
| Designation |
Research Officer (Pathology) S-IV |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room No. 516, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
8800263300 |
| Fax |
|
| Email |
drpradeepkumar2001@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Infrastructural support : 1 Regional Research Institute of Unani Medicine (RRIUM), Mumbai
2. Clinical Research Unit (CRU), Meerut Monetary Support: Central Council for Research in Unani Medicine (CCRUM), New Delhi |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Unani Medicine CCRUM New Delhi |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi-110058 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mohd Naseem |
Clinical Research Unit, Meerut |
Research OPD Room Salas-ul-Baul (Stress Urinary Incontinence),Cantonment General Hospital, Begum Bridge
Meerut
UTTAR PRADESH |
8451934661
naseemrrium786@gmail.com |
| Dr Humaira Bano |
Regional Research Institute of Unani Medicine, Mumbai |
Research OPD Room Salas-ul-Baul (Stress Urinary Incontinence), Behind Eye Bank, Sir JJ. Hospital Compound, Byculla
Mumbai
MAHARASHTRA |
8439430091
banu786.mau@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Clinical Research Unit, Meerut |
Submittted/Under Review |
| Regional Research Institute of Unani Medicine, Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N393||Stress incontinence (female) (male), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Kundri |
6gm twice daily to be taken orally with water for twelve weeks |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. 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
|
|
| ExclusionCriteria |
| Details |
1. Pregnant women.
2. Obese/Fatty abdomen.
3. Prolapsed disc and dislocated vertebrae.
4. 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. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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
|
| Outcome |
TimePoints |
| Haematological and biochemical assessment for safety assessment |
At every 2 weeks till 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="220"
Sample Size from India="220"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
30/06/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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 | |