| CTRI Number |
CTRI/2023/07/055067 [Registered on: 11/07/2023] Trial Registered Prospectively |
| Last Modified On: |
08/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effect of Gokshuradi churna and Swayamguptadi churna on oligospermia |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the efficacy of Gokshuraadi churna and Swayamguptadi churna on Purush Bandhyatva W.S.R to Oligospermia |
| 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 Liyakat Ahmed |
| Designation |
PG Scholar |
| Affiliation |
Madan Mohan Malaviya Government Ayurved College Udaipur |
| Address |
PG Scholar
Prasuti Evam Striroga Department
Madan Mohan Malaviya Government Ayurved College
Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
9636371550 |
| Fax |
|
| Email |
liyakatahmed007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Narendra Kumar Meena |
| Designation |
Associate Professor |
| Affiliation |
Madan Mohan Malaviya Government Ayurved College Udaipur |
| Address |
Associate Professor
Prasuti Evam Striroga Department
Madan Mohan Malaviya Government Ayurved College
Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
9950129673 |
| Fax |
|
| Email |
narendermeena42@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Narendra Kumar Meena |
| Designation |
Associate Professor |
| Affiliation |
Madan Mohan Malaviya Government Ayurved College Udaipur |
| Address |
Associate Professor
Prasuti Evam Striroga Department
Madan Mohan Malaviya Government Ayurved College
Udaipur
RAJASTHAN
313001
India |
| Phone |
9950129673 |
| Fax |
|
| Email |
narendermeena42@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Madan Mohan Malaviya Government Ayurved College Udaipur |
|
|
Primary Sponsor
|
| Name |
Madan Mohan Malaviya Government Ayurved College Udaipur |
| Address |
Madan Mohan Malviya Government Ayurved college Udaipur
Pin 313001 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Liyakat Ahmed |
Madan Mohan Malaviya Government Ayurved College Udaipur |
OPD No:5
PG Department of Prasuti Evam Striroga Department
Associated group of hospitals
Madan Mohan Malaviya Government Ayurved College Udaipur
PIN 313001
Udaipur
RAJASTHAN |
9636371550
liyakatahmed007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee M.M.M. Govt.Ayurved College Udaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N461||Oligospermia. Ayurveda Condition: SUKRAKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Gokshuraadi churna, Reference: Ashtangahriday, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: milk), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Swayamguptadi churna, Reference: Chakradutta, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: milk), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Male |
| Details |
1)Patients suffering from signs and symptoms of oligospermia
2)Sperm count below 20 millions/ml
|
|
| ExclusionCriteria |
| Details |
1)Below 21 yrs and above 50 yrs
2)Patients with absolute azoospermia
3)Congenital anomalies of genital organs |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Increase in the sperm count |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1)Increase in the sperm count |
2 weeks,4 weeks,6 weeks,8 weeks & 10 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2 |
|
Date of First Enrollment (India)
|
30/07/2023 |
| 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="3"
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
|
This is a multiple arm,parallel group study.In this study group A-30 patients will be administered with Gokshuradi churna,5 gm,twice a day,after food and group B-30 patients will be administered with Swayamguptadi churna,5 gm,twice a day,after foof. |