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CTRI Number  CTRI/2015/10/006290 [Registered on: 21/10/2015] Trial Registered Retrospectively
Last Modified On: 26/02/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Unani 
Study Design  Single Arm Study 
Public Title of Study   To evaluate the Safety and efficacy of Unani formulation Majoon Supari paak in Sayalān al-Rahim (Leucorrhoea) 
Scientific Title of Study   Clinical Validation of Unani Pharmacopoeial formulation Majoon Supari paak in Sayalān al-Rahim (Leucorrhoea) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
SR/L/MSP CLNVAL/CCRUM 14-15 version 1  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  PROF RAIS UR RAHMAN 
Designation  DIRECTOR GENERAL 
Affiliation  Central Council for Research in Unani Medicine (CCRUM) 
Address  awahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri

West
DELHI
110058
India 
Phone  9313980776  
Fax  28522965  
Email  drrahman002@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr K M Siddiqui 
Designation  Deputy DIRECTOR GENERAL 
Affiliation  Central Council for Research in Unani Medicine (CCRUM) 
Address  awahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri

West
DELHI
110058
India 
Phone  9810161758  
Fax  28522965  
Email  ccrum57@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Pradeep Kumar 
Designation  Research Officer 
Affiliation  Central Council for Research in Unani Medicine (CCRUM) 
Address  awahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri

West
DELHI
110058
India 
Phone  8800263300  
Fax  28522965  
Email  drpradeepkumar2001@gmail.com  
 
Source of Monetary or Material Support  
InfrastructuralSupport:1.Central Research Institute of Unani Medicine (CRIUM), Hyderabad 2. Regional Research Institute of Unani Medicine, Aligarh 3.Monetary Support : Central Council for Research in Unani Medicine, Patna Monetary Support : Central Council for Research in Unani Medicine, New Delhi  
 
Primary Sponsor  
Name  Central Council for Research in Unani Medicine 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  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Syeda Khadeerunnisa  Central Research Institute of Unani Medicine (CRIUM), Hyderabad  AG Colony road, Erragadda
Hyderabad
ANDHRA PRADESH 		 9397953137

syedakhadeerunnisa@criumhyderabad.net 
Dr Shagufta Rehman  Regional Research Institute of Unani Medicine (RRIUM), Aligarh  Post Box 70, Near Head Post Office
Aligarh
UTTAR PRADESH 		 9456667107

drrehmanshagufta@gmail.com 
Dr Mrs Najmus Sehar  Regional Research Institute of Unani Medicine (RRIUM), Patna  Guzri, Patna City
Patna
BIHAR 		 09431651861

nsehar.ccrum@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Central Research Institute of Unani Medicine (CRIUM), Hyderabad  Submittted/Under Review 
Regional Research Institute of Unani Medicine (RRIUM), Aligarh  Approved 
Regional Research Institute of Unani Medicine (RRIUM), Patna  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N898||Other specified noninflammatory disorders of vagina,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Majoon Supari paak  7gms twice Daily orally after meals with water for aduration of 4 weeks  
Comparator Agent  nil  nil 
 
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
• Waja‘ al-Zahr (Backache)
• Naqahat (General Weakness)
• Faqr al-Dam (Anaemia) (8-10 mg % in females)
 
 
ExclusionCriteria 
Details  • Patients having acute/ acute on chronic/Chronic PIDs (as per the CDC Diagnostic Criteria attached as an 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   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
improvement in the sign and symptoms of Sayalān al-Rahim (Leucorrhoea)  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)   01/06/2015 
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   his study is designed as a multicentric open trial in patients with Sayalān al-Rahim (Leucorrhoea)  After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria.  The patients will be assessed clinically at every two weeks.  This includes subjective assessment of general well being and physical examination . The total duration of treatment will be 4 weeks. . Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.
Composition of Majoon Supari paak

1.      Khurma Khushk                                                                                  500g

2.      Fofil                                                                                                    250g

3.      Majeeth                                                                                               125g

4.      Sheer e Gao                                                                                         10 litres

5.      Maghz e Badam Shireen                                                                     500g

6.      Nishasta Gandum Biryan                                                                    250g

7.      Samagh e Arabi Biryan                                                                       250g

8.      Arad e Moong                                                                                     125g

9.      Raughan e Zard                                                                                  1kg

10.  Qand e Safaid                                                                                     3 kg

11.  Khar e Khask Khurd                                                                           500g

12.  Samagh e Dhak                                                                                   250g

13.  Maghz e Narjeel Khushk                                                                    250g

14.  Salab Misri                                                                                          55g

15.  Darchini                                                                                              55g

16.  Qaranfal                                                                                              55g

17.  Heel khurd                                                                                          55g

18.  Zanjabeel                                                                                             55g

19.  Jauz buwa                                                                                           25g

20.  Gul e Supari                                                                                        15g

21.  Gul e pista                                                                                           15g

22.  Post e Kachnaal                                                                                  10g

23.  Post e Mughilaan                                                                                10g

24.  Post e Sankhaholi                                                                                10g

25.  Zafraan                                                                                                50g     

 

 
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