FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/02/080398 [Registered on: 12/02/2025] Trial Registered Prospectively
Last Modified On: 08/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   To increase the sperm count by Gunja Moola. 
Scientific Title of Study   Evaluation of Shukra Vardhana effect of Gunja Moola in management of Ksheena Shukra or Oligospermi in adult male:A Randomised Control Clinical Trial. 
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 Varun Kumar Dhruw 
Designation  PG Scholar  
Affiliation  Shri Narayan Prasad Awasthi Govt Ayurved college GE road raipur chhatisgarh pin code 492010 
Address  Shri Narayan Prasad Awasthi Govt Ayurved college pg building first floor room number 4 GE road raipur chhatisgarh pin code 492010

Raipur
CHHATTISGARH
492010
India 
Phone  7745980421  
Fax    
Email  varundhruw6355@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pravin Kumar Joshi  
Designation  HOD& professor in department of Dravya Guna vigyan  
Affiliation  Shri Narayan Prasad Awasthi Govt Ayurved college GE road raipur chhatisgarh pin code 492010 
Address  New Pg building Room number 1 first floor Shri Narayan Prasad Awasthi Govt Ayurved college pg block GE road raipur chhatisgarh pin code 492010

Raipur
CHHATTISGARH
492010
India 
Phone  9407649488  
Fax    
Email  pravinkumarjoshi7000@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr C P Sinha 
Designation  Lecturer in Department of Kay Chikitsa  
Affiliation  Shri Narayan Prasad Awasthi Govt Ayurved college GE road raipur chhatisgarh pin code 492010 
Address  Old UG building Room number 5 Kay chikitsa department,Shri Narayan Prasad Awasthi Govt Ayurved college GE road raipur chhatisgarh pin code 492010

Raipur
CHHATTISGARH
492010
India 
Phone  8225000010  
Fax    
Email  drcspsinha@gmail.com  
 
Source of Monetary or Material Support  
Kay Chikitsa Clinic in shri khudadad dungaji Govt Ayurved college hospital GE road raipur chhatisgarh pin code 492010 
 
Primary Sponsor  
Name  Shri khudadad dungaji Govt Ayurved college hospital GE road raipur chhatisgarh pin code 492010 
Address  Shri Narayan Prasad Awasthi Govt Ayurved college GE road raipur chhatisgarh pin code 492010 
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 Varun Kumar Dhruw   Kaya Chikitsa Clinic Room number 2 in shri khudadad dungaji hospital Raipur Chhattisgarh   Shri Narayan Prasad Awasthi Govt Ayurved college GE road raipur chhatisgarh pin code 492010
Raipur
CHHATTISGARH 		 7974861527

varundhruw6355@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Shri Narayan Prasad Awasthi Govt Ayurved college Raipur Chhattisgarh   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: Abdus pictorius mool, Reference: Rasa Tarangani 24/459-462, Route: Oral, Dosage Form: Churna/ Powder, Dose: 4(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Ksheera ), Additional Information: Abdus pictorius(Gunja Moola)
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  45.00 Year(s)
Gender  Male 
Details  Age group between 25 to 45 years.
Patients having Shastrokta symptoms of Ksheena Shukra.
Sperm count below 15 million/ml Patient with clinical presentation of Ksheena Shukra mentioned in classics i.e, Daurbalya, Panduta, Sadana, Shrama, Klaibya, Maithuna Ashakti, Chiraat Praseka, Shukra Avisarga, Medhra-Vrishana Vedana.
Patients who has given consent for clinical trial. 
 
ExclusionCriteria 
Details  Age below 25 and above 45,
Sperm count not above 15 million
No sexual gland related disordes 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
There will be significant effect of Gunja Moola to improve sperm count.  6week 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in life style   8 weeks  
 
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 1 
Date of First Enrollment (India)   19/02/2025 
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="0"
Months="1"
Days="15" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   Clinical infertility is the inability of a couple to conceive after 12 months of trying. According to the WHO, roughly 1 in 6 couple has been affected. Worldwide, approximately 17.5% of the adult population is affected.The rates are comparable for high, middle and low income countries, indicating that this is a major health challenge globally.Lifetime prevalence was 17.8% in high-income countries and 16.5% in low and middle-income countries. 
Close