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CTRI Number  CTRI/2024/10/075266 [Registered on: 15/10/2024] Trial Registered Prospectively
Last Modified On: 01/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Study of oligospermia patients with unani medicine majun e piyaz to increase sperm count  
Scientific Title of Study   A single blind randomized controlled clinical trial to evaluate the safety and efficacy of majun piyaz in cases of qillate mani (oligosperma) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shaik Saifur Rehman  
Designation  PG Scholar  
Affiliation  Government Nizamia Tibbi College and General Hospital 
Address  OPD No. 122 PG Department of Moalijat Government Nizamia Tibbi College and General Hospital, Charminar Hyderabad Hyderabad TELANGANA

Hyderabad
TELANGANA
500002
India 
Phone  8374161365  
Fax    
Email  shaikrehman705@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mohammed Ahsan Faroqui  
Designation  HOD and professor PG department of moalijat 
Affiliation  Government Nizamia Tibbi College and General Hospital 
Address  OPD No. 122 PG Department of Moalijat Government Nizamia Tibbi College and General Hospital, Charminar Hyderabad Hyderabad TELANGANA

Hyderabad
TELANGANA
50002
India 
Phone  9849139356  
Fax    
Email  dr.faroqui@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shaik Saifur Rehman  
Designation  PG Scholar 
Affiliation  Government Nizamia Tibbi College and General Hospital 
Address  OPD No. 122 PG Department of Moalijat Government Nizamia Tibbi College and General Hospital, Charminar Hyderabad Hyderabad TELANGANA

Hyderabad
TELANGANA
500002
India 
Phone  8374161365  
Fax    
Email  shaikrehman705@gmail.com  
 
Source of Monetary or Material Support  
Government Nizamia Tibbi College and General hospital Charminar Hyderabad Telangana 500002 India 
 
Primary Sponsor  
Name  Government Nizamia Tibbi College and General hospital 
Address  Government Nizamia Tibbi College and General hospital Charminar, Hyderabad Telangana 500002. India TELANGANA 500002 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shaik Saifur Rehman   Government Nizamia Tibbi College and General hospital   OPD No. 122 PG Department of Moalijat Government Nizamia Tibbi College and General hospital
Hyderabad
TELANGANA 		 8374161365

shaikrehman705@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethic Committee IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N461||Oligospermia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Clomiphene Citrate   25 mg daily OD after meal given for 24 days in a month with 6 days gap for 60 days 
Intervention  Majun e piyaz  12 gm. in morning with cow milk for 60 days  
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  55.00 Year(s)
Gender  Male 
Details  Age between 25-55 years.
All socio-economical classes.
No past history of renal, hepatic or any other chronic illness.
History of unprotective intercourse for period of 12 months
Infertile oligopsermia patient without any delayed puberty
Infertile patient having oligospermia less than 15 million/ml of semen.
Patients who willing for semen examination after the treatment.
 
 
ExclusionCriteria 
Details  Patient with complete Azoospermia in pre-samples.
Evidence of male accessory gland infection like orchitis, mumps, varicocele and trauma to testis, excessive radiation to the testis and uncorrected bilateral cryptorchidism.
Taking anti TB drugs, alpha blockers, spironolactone and any cytotoxic drugs.
Patients suffering with anti-immune diseases like STD, HIV.
Patient with diabetes mellitus,cardiac and thyroid diseases.
Hormone treatment for promoting fertilty in the last three months,psychologically or mentally ill patients.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Increase in sperm count  Day 0,day 30,day 60  
 
Secondary Outcome  
Outcome  TimePoints 
Increase in male fertility   Day 0, day 30, day 60 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   15/10/2024 
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="1"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   The study is going to be conducted on patients with oligospermia, total sample size is 40 divided in 2 groups, group A and group B, group A will be given control drug i.e Clomiphene Citrate 25mg daily OD for 24 days with 6 days gap for 60 days. Group B will be given Majun piyaz 12 gram morning with cow milk for 60 days. Patient is assessed on day 0, day 30, day 60. The outcome is measured by semen analysis. 
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