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CTRI Number  CTRI/2021/09/036415 [Registered on: 10/09/2021] Trial Registered Prospectively
Last Modified On: 09/09/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   a clinical study to evaluate the comparative effect of shatavari and ashwagandha on shukra kshaya 
Scientific Title of Study   A Clinical Study To Evaluate The Comparative Effects of Shatavari and Ashwagandha on Oligospermia 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shubham Bansal 
Designation  PG student 
Affiliation  Government Ayurvedic college Patiala 
Address  Post graduate training and research institute Government Ayurvedic college Patiala
Post graduate training and research institute Government Ayurvedic college Patiala
Patiala
PUNJAB
147001
India 
Phone  7589079611  
Fax    
Email  dr.shubhambansal611@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrRosy Gupta  
Designation  Reader 
Affiliation  Government Ayurvedic college Patiala 
Address  Post graduate training and research institute Government Ayurvedic college Patiala
Post graduate training and research institute Government Ayurvedic college Patiala
Patiala
PUNJAB
147001
India 
Phone  9815818190  
Fax    
Email  rrgu04@gmail.com  
 
Details of Contact Person
Public Query  
Name  Shubham Bansal 
Designation  PG student 
Affiliation  Government Ayurvedic college Patiala 
Address  Post graduate training and research institute Government Ayurvedic college Patiala
Post graduate training and research institute Government Ayurvedic college Patiala
Patiala
PUNJAB
147001
India 
Phone  7589079611  
Fax    
Email  dr.shubhambansal611@gmail.com  
 
Source of Monetary or Material Support  
Government ayurvedic college, patiala  
 
Primary Sponsor  
Name  Government ayurvedic college patiala  
Address  Post graduate training and research institute Government Ayurvedic college Patiala 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
shubham bansal  post graduate training and research institute government ayurvedic college patiala 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Shubham Bansal   Government Ayurvedic Hospital  Government Ayurvedic Hospital, Shere Punjab market, Patiala
Patiala
PUNJAB 		 7589079611

dr.shubhambansal611@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  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: shukra kshaya,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Ashwagandha and shatavari , Reference: Bhavprakash , Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -milk), Additional Information:
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  45.00 Year(s)
Gender  Male 
Details  individuals giving written consent for the study.
marital status: married
pt. fulfilling the diagnostic criteria as per clinical performa. 
 
ExclusionCriteria 
Details  individuals not giving written consent for the study.
pt. having corticosteroids.
pt. with azoospermia.
BMI>30kg/m2
pt. anatomical disabilities of male reproductive organ like varicocele, hydrocele, absence or blockage of passage tubules. 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
shatavari and ashwagandha possess significantly different effects on shukra kshaya.  after 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
shatavari and ashwagandha do not possess significantly different effects on shukra kshaya.  after 3 months 
 
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   N/A 
Date of First Enrollment (India)   23/09/2021 
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="15" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   will be published as pg thesis 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [dr.shubhambansal611@gmail.com].

  6. For how long will this data be available start date provided 23-09-2021 and end date provided 23-09-2022?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   this study is randomized, open, parallel group, interventional type, single center trial comparing the efficacy of shatavari 3gms twice a day and ashwagandha 3gms twice a day for 90 days in 40 patients with shukra kshaya that will be conducted in single center in India. The primary outcome measures will be significantly different effects of shatavari and ashwagandha on shukra kshaya in 90 days. The secondary outcome measures will be no significantly different effects of shatavari and ashwagandha on shukra kshaya in 90 days trial. 
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