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CTRI Number  CTRI/2021/05/033350 [Registered on: 04/05/2021] Trial Registered Prospectively
Last Modified On: 03/05/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Unani 
Study Design  Single Arm Study 
Public Title of Study   Clinical validation study to evaluate the efficacy and safety of Unani pharmacopoeial formulation-Majun Zanjabeel in Kasrat-e-Tams(Heavy Menstrual Bleeding) 
Scientific Title of Study   open label,single arm clinical study to evaluate the efficacy and safety of unani pharmacopoeial formulation -Majun Zanjabeel in kasrat-e-Tams(Heavy menstrual Bleeding) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Arjumand 
Designation  Research officer 
Affiliation  Regional research Institute of Unani Medicine ,Srinagar(CCRUM Ministry of AYUSH) 
Address  Regional Research Institute of Unani Medicine
Habbak Naseem Bagh University of kashmir Campus Srinagar
Srinagar
JAMMU & KASHMIR
190006
India 
Phone  7006180746  
Fax    
Email  dr.arjumandshah111@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Arjumand 
Designation  Research officer 
Affiliation  Regional research Institute of Unani Medicine ,Srinagar(CCRUM Ministry of AYUSH) 
Address  Regional Research Institute of Unani Medicine
Habbak Naseem Bagh University of kashmir Campus Srinagar
Srinagar
JAMMU & KASHMIR
190006
India 
Phone  7006180746  
Fax    
Email  dr.arjumandshah111@gmail.com  
 
Details of Contact Person
Public Query  
Name  Towseef Amin rafeeqi 
Designation  Research Officer Biochemistry 
Affiliation  Regional research Institute of Unani Medicine ,Srinagar(CCRUM Ministry of AYUSH) 
Address  Regional Research Institute of Unani Medicine
Habbak Naseem Bagh University of kashmir Campus Srinagar
Srinagar
JAMMU & KASHMIR
190006
India 
Phone    
Fax    
Email  towseef@gmail.com  
 
Source of Monetary or Material Support  
Central Council for Research in Unani Medicine 
 
Primary Sponsor  
Name  Central Council for Research in Unani Medicine 
Address  D-Block Janak Puri New Delhi  
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
Central Council for Research in Unani Medicine  D Block Janak Puri New Delhi 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Arjumand Shah  Regional Research Institute of Unani Medicine   Habak Naseem Bagh University of Kashmir Campus
Srinagar
JAMMU & KASHMIR 		 7006180746

dr.arjumandshah111@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethical Committee Regional Research Institute of Unani Medicine  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: N939||Abnormal uterine and vaginal bleeding, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Majun Zanjabeel  5gm two times a day given orally for 12 weeks (given only for 9 days each month starting from day 1 of menstrual cycle for three consuctive cycles)  
Comparator Agent  Not applicable  Not applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Non Gravid females of reproductive age
patients with menorrhagia as indicated by
i) Excessive menstrual loss greater than 80 ml per cycle as calculated by menstrual pictogram
ii) Menstrual cycle greater than 6 days  
 
ExclusionCriteria 
Details  1. Heavy Menstrual Bleeding with structural or histological abnormality with symptoms such as Intermenstrual or post coital bleeding pelvic pain and or pressure symptoms
2. Patients presenting with Heavy Menstrual Bleeding since menoarche
• Patients with a personal or family history suggesting a coagulation disorder
• Patients using Intrauterine Contraceptive Devices
• Patients with illness requiring long term treatment e.g Hypertension TB etc
• Patients with Post-menopausal bleeding
• Patients with HMB taking Hormone Replacement Therapy
• Conditions where HBM is not the main presenting menstrual symptom eg endometriosis
• Pregnant and lactating females
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Decrease in blood loss during the menstural cycle .  patients will be assessed at 4 weeks followed by 8 weeks and 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
safety of drug in terms of vital and laboratory parameters   for vitals the patients will be assessed at baseline followed by 4 weeks 8 week and 12 week whereas, for laboratory parameters patients will be assessed at baseline and at 12 week of the study  
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/05/2021 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This is an Open label single arm clinical study which will be done in Regional Institute for Unani Medicine Srinagar in which the efficacy and safety of Unani Pharmacopeial formulation Majun Zanjabeel will be assessed in patients of Kasrat e tams  (heavy menstrual bleeding) 
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