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CTRI Number  CTRI/2022/09/046068 [Registered on: 30/09/2022] Trial Registered Prospectively
Last Modified On: 23/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study of Apatyakar Ghrita in Ksheena Shukra 
Scientific Title of Study   Pharmaceutical Standardization of Apatyakar Ghrita prepared by Naveena & Purana ghrita & their comparative effect on Ksheena Shukra w.s.r. to oligozoospermia 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Gaurav Kumar Singh 
Designation  MD Scholar 
Affiliation  Government Ayurvedic College, Chaukaghat, Varanasi 
Address  Department of Rasashastra and Bhaishajya kalpana Government Ayurvedic College, Chaukaghat, Varanasi

Varanasi
UTTAR PRADESH
221002
India 
Phone  8006447666  
Fax    
Email  gauravnitin05@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Parwez Ahmad Ansari 
Designation  Assistant Professor 
Affiliation  Government Ayurvedic College, Chaukaghat, Varanasi 
Address  Department of Rasashastra and Bhaishajya kalpana Government Ayurvedic College, Chaukaghat, Varanasi

Varanasi
UTTAR PRADESH
221002
India 
Phone  8081373553  
Fax    
Email  drpaansari@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ajay Kumar 
Designation  Assistant Professor 
Affiliation  Government Ayurvedic College, Chaukaghat, Varanasi 
Address  Department of Kaya Chikitsa Government Ayurvedic College, Chaukaghat, Varanasi

Varanasi
UTTAR PRADESH
221002
India 
Phone  9616870871  
Fax    
Email  drajay2000@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurvedic College, Chaukaghat, Varanasi 
 
Primary Sponsor  
Name  Government Ayurvedic College Chaukaghat Varanasi 
Address  Government Ayurvedic College, Chaukaghat, Varanasi 
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 Gaurav Kumar Singh  Government Ayurvedic college & Hospital  OPD No 5 Department of Rasa shastra and Bhaishajya Kalpna, OPD No 11 Department of Kaya Chikitsa Government Ayurvedic College & Hospital, Chaukaghat, Varanasi
Varanasi
UTTAR PRADESH 		 8006447666

gauravnitin05@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Government Ayurvedic College & Hospital, Chaukaghat, Varanasi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N461||Oligospermia. Ayurveda Condition: SUKRAKSHAYAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Apatyakar Ghrita, Reference: Charak Chikitsa 2-4/29, Route: Oral, Dosage Form: Ghrita, Dose: 6(ml), Frequency: bd, Bhaishajya Kal: Sabhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -Milk), Additional Information: -Apatyakar Ghrita prepared from Purana Ghrita
2Intervention ArmDrugClassical(1) Medicine Name: Apatyakar Ghrita, Reference: Charak Chikitsa 2-4/29, Route: Oral, Dosage Form: Ghrita, Dose: 6(ml), Frequency: bd, Bhaishajya Kal: Sabhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Milk), Additional Information: Apatyakar Ghrita prepared by Naveena Ghrita
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Male 
Details  1. Male partner of a couple presenting for infertility.
2. Moderate abnormalities of semen parameters (Mean sperm density <20 million, but ≥ 3
million/ml), and/or motility < 50%, and/or < 4% abnormal morphology on at least two
separate occasions as per WHO Criteria. 
 
ExclusionCriteria 
Details  1. Subjects were under treatment of gonadotropin, anabolic steroid, chemotherapeutic
drugs, or nonsteroidal anti-inflammatory drugs.
2. Vasectomy reversal.
3. Regular use of tobacco products.
4. Inability or unwillingness to participate in evaluations required by the study.
5. Subjects associated with systemic illness such as Diabetes or Hypertension.
6. Subjects had heat, chemicals, radioactive material, or toxic contact history within a year.
7. Patients suffering from congenital reproductive system deformities and Patients
suffering from sexually transmitted diseases.
8. If any adverse effect is observed in patient after consuming Apatyakar Ghrita.  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in Sperm Count  90 Days 
 
Secondary Outcome  
Outcome  TimePoints 
Enhance the strenght and complexion of body.
Improve Routine Activity 		 4 week, 8 week 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/10/2022 
Date of Study Completion (India) 30/06/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Not yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  		 Interventional Study

Patient suffering from oligozoospermia will be selected from OPD of Govt. Ayurvedic College & Hospital, Chaukaghat, Varanasi

Total Patient = 60

Treatment Plan :-

GROUP A – 30 patients of Group A will be treated by Apatyakar Ghrita prepared with Naveena Ghrita.

GROUP B – 30 patients of Group B will be treated by Apatyakar Ghrita prepared with Purana Ghrita.

Follow up - 15 days for 3 Month  

Result -
Under this clinical study, min 60 patient of oligozoospermia was registered but only 50 patient completed the trial. 26 patient were given Apatykar ghrita prepared from Naveena ghrita and 24 patient was given Apatyakar ghrita prepared from Purana ghrita. This medication improve the quality of sperm in terms of Sperm count, sperm motility, and sperm morphology. The overall effect in group A was 60.46% where as in group B was 59.4% Effect of therapy was approximately same. Hence differences in the effect of Apatyakar ghrita prepared from Naveena ghrita and Apatyakar ghrita prepared from Purana ghrita were statistically non-significant.
 
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