| CTRI Number |
CTRI/2018/10/016168 [Registered on: 26/10/2018] Trial Registered Retrospectively |
| Last Modified On: |
21/02/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effects of Unani formulation Safoof e Sailan in SayalÄn al-Rahim (Leucorrhoea) |
|
Scientific Title of Study
|
Clinical Validation of Unani Pharmacopoeial formulation Safoof e Sailan in SayalÄn al-Rahim (Leucorrhoea)
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SR/L/SS CLNVAL/CCRUM 15-16 version 1 |
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 |
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
|
| Fax |
|
| Email |
unanimedicine@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naheed Parveen |
| 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
South West
DELHI
110058
India |
| Phone |
|
| Fax |
|
| Email |
ccrum507@rediffmail.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
South West
DELHI
110058
India |
| Phone |
|
| Fax |
|
| Email |
drpradeepkumar2001@gmail.com |
|
|
Source of Monetary or Material Support
|
| InfrastructuralSupport:1.Central Research Institute of Unani Medicine, Hyderabad 2.Regional Research Institute of Unani Medicine Patna, 3. Regional Research Institute of Unani Medicine Mumbai 4. Clinical Research Unit Kurnool 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 Syeda Khadeerunnisa |
Central Research Institute of Unani Medicine |
Research OPD (Leucorrhoea), AG Road, Eragadda
Hyderabad
ANDHRA PRADESH |
9397953137
syedakhadeerunnisa@criumhyderabad.net |
| Dr Jawadul Haq |
Clinical Research Unit |
Research OPD (Leucorrhoea), 40/23 Park Road
Kurnool
ANDHRA PRADESH |
9502443555
cru.kurnool@gmail.com |
| Dr Mahboob us Salam |
Regional Research Institute of Unani Medicine |
Reserach OPD (Leucorrhoea), Guzri, Patna City
Patna
BIHAR |
9910460809
rriumpatna@gmail.com |
| Dr Nikhat Shaikh |
Regional Research Institute of Unani Medicine |
Research OPD (Leucorrhoea), Sir J J Hospital Compound,Byculla
Mumbai
MAHARASHTRA |
09566255415
drnikhat.unani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Central Research Institute of Unani Medicine, Hyderabad |
Submittted/Under Review |
| Regional Research Institute of Unani Medicine, Patna |
Approved |
| Clinical Research Unit, Kurnool |
Submittted/Under Review |
| Regional Research Institute of Unani Medicine, Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
SayalÄn al-Rahim (Leucorrhoea), (1) ICD-10 Condition: N899||Noninflammatory disorder of vagina, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
Safoof e Sailan |
3 gms twice daily with water after meals for two weeks |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
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)
|
|
| ExclusionCriteria |
| Details |
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.
|
|
|
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 SayalÄn al-Rahim (Leucorrhoea) |
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haematological and biochemical assessment for safety assessment |
At baseline and end oftreatment |
|
|
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)
|
15/02/2016 |
| 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
|
None Yet |
|
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 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
|
|