| CTRI Number |
CTRI/2015/02/005562 [Registered on: 23/02/2015] Trial Registered Retrospectively |
| Last Modified On: |
21/02/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To evaluate the Safety and efficacy of two Unani formulations in the treatment of Leucorrhoea |
|
Scientific Title of Study
|
Clinical Validation of Unani Pharmacopoeial formulation Kushta Khubs ul Hadeed and Habb e Marwareed in Sailan-ur-Reham(Leucorrhoea) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SR/L/QKH HM CLNVAL/CCRUM 13-14 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PROF S SHAKIR JAMIL |
| Designation |
DIRECTOR GENERAL |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
West
DELHI
110058
India |
| Phone |
01128521981 |
| Fax |
01128522965 |
| Email |
ccrum605@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Khalid M Siddiqui |
| Designation |
DEPUTY DIRECTOR GENERAL |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
West
DELHI
110058
India |
| Phone |
9810161758 |
| Fax |
01128522965 |
| Email |
ccrum507@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep Kumar |
| Designation |
RESEARCH OFFICER SCIENTIST III |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
West
DELHI
110058
India |
| Phone |
01128521981 |
| Fax |
01128522965 |
| Email |
drpradeepkumar2001@gmail.com |
|
|
Source of Monetary or Material Support
|
| Infrastructural support:1.Central Research Institute of Unani Medicine,Lucknow 2.Regional Research Institute of Unani Medicine,Delhi 3. Regional Research Institute of Unani Medicine, Aligarh 4. Regional Research Institute of Unani Medicine, Patna 5. Clinical Research Unit, Kerala Monetary Support : Central Council for Research in Unani Medicine, New Delhi |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Unani Medicine |
| 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 = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR S M QASIM |
Central Research Institute of Unani Medicine (CRIUM), Lucknow |
C-39, Jankipuram,P.O., Sector-C ,Terhi Puliya, Kursi Road
Lucknow
UTTAR PRADESH |
05222361720
05222732088
crium_lko@yahoo.co.in |
| DR SHAGUFTA REHMAN |
Regional Research Institute of Unani Medicine (RRIUM), Aligarh |
Post Box 70, Near Head Post Office,
Aligarh
Aligarh
UTTAR PRADESH |
05712704781
rrium_aligarh@rediffmail.com |
| DR NAHEED PARVEEN |
Regional Research Institute of Unani Medicine (RRIUM), New Delhi |
D-11, Abul Fazal Enclave, Jamia Nagar, New Delhi-25
South
DELHI |
01126952759
rriumdelhi@gmail.com |
| DR MRS NAJMUS SEHAR |
Regional Research Institute of Unani Medicine (RRIUM), Patna |
Manas Path opp. Patna City Hospital
Patna
Patna
BIHAR |
06122631106
nsehar.ccrum@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Central Research Institute of Unani Medicine (CRIUM), Lucknow |
Approved |
| Regional Research Institute of Unani Medicine (RRIUM), Aligarh |
Approved |
| Regional Research Institute of Unani Medicine (RRIUM), New Delhi |
Approved |
| Regional Research Institute of Unani Medicine (RRIUM), Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Sailan-ur-Reham(Leucorrhoea), (1) ICD-10 Condition: A599||Trichomoniasis, unspecified, (2) ICD-10 Condition: A599||Trichomoniasis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Habb e Marwareed |
Orally 1 Tab (250 mg)
Twice Daily Take after meals with water for 4 weeks
|
| Comparator Agent |
nil |
na |
| Intervention |
Qurs e Kushta Khabs al-Hadeed |
1Tab (100 mg) Twice Daily Take after meals with water for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
• 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
|
|
| ExclusionCriteria |
| Details |
• 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.
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in signs and symptoms |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hematological and biochemical assessments for safety |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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 2 |
|
Date of First Enrollment (India)
|
02/04/2014 |
| 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) |
Open to Recruitment |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
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
|
|