| CTRI Number |
CTRI/2024/11/077333 [Registered on: 25/11/2024] Trial Registered Prospectively |
| Last Modified On: |
21/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to study the effect of shatavaryadi churna in patients with oligospermia |
|
Scientific Title of Study
|
Randomized uncontrol clinical trial of efficacy of shatavaryadi churna in shukrakshaya with special reference 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 |
Rinkal Sarkarsing Rajput |
| Designation |
Post Graduate Resident |
| Affiliation |
Hon. Shree Annasaheb Dange Ayurved Medical College, Ashta Tal-Walwa Dist-Sangli |
| Address |
Department of strirog and prasutitantra of Dhanwantari Hospital of Hon. Shree Annasaheb Dange Ayurved Medical College, Ashta Tal-Walwa Dist-Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
9172736889 |
| Fax |
|
| Email |
rinkalrajput1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dilip Katare |
| Designation |
HOD |
| Affiliation |
Hon. Shree Annasaheb Dange Ayurved Medical College, Ashta Tal-Walwa Dist-Sangli |
| Address |
Department of strirog and prasutitantra of Dhanwantari hospital of Hon. Shree Annasaheb Dange Ayurved Medical College, Ashta Tal-Walwa Dist-Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
9881215521 |
| Fax |
|
| Email |
drdilipkatareashta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dilip Katare |
| Designation |
HOD |
| Affiliation |
Hon. Shree Annasaheb Dange Ayurved Medical College, Ashta Tal-Walwa Dist-Sangli |
| Address |
Department of strirog and prasutitantra of Dhanwantari hospital of Hon. Shree Annasaheb Dange Ayurved Medical College, Ashta Tal-Walwa Dist-Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
9881215521 |
| Fax |
|
| Email |
drdilipkatareashta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of strirog and prasutitantra of Dhanvantari Hospital of Hon. Shree Annasaheb Dange Ayurved Medical College, Ashta Tal-Walwa Dist-Sangli, Maharashtra Pin code-416301, INDIA |
|
|
Primary Sponsor
|
| Name |
Rinkal Sarkarsingh Rajput |
| Address |
Department of strirog and prasutitantra of Dhanwantari hospital of Hon. Shree Annasaheb Dange Ayurved Medical College, Ashta Tal-Walwa Dist-Sangli, Maharashtra,Pin code-416301, INDIA |
| Type of Sponsor |
Private 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 |
| Rinkal Rajput |
Dhanwantari Hospital of ADAMC Ashta Tal-Walwa Dist-Sangli, Maharashtra 416301,India |
OPD no 16, Department of strirog and prasutitantra, Ashta Tal Walwa Dist Sangli, 416301
Sangli
MAHARASHTRA |
9172736889
rinkalrajput1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| S.D.S.’S Annasaheb Dange Ayurved Medical College,Sangli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N461||Oligospermia. Ayurveda Condition: shukr, (2) ICD-10 Condition:N461||Oligospermia. Ayurveda Condition: SUKRAKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shatavaryadi churna, Reference: Yogratnakar Samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: Madhu+ Ghrut), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
1. Age above 25 year and below 45 years
2.Patient having total sperm concentration less than 15million per ml.
3.Patient with clinical presentation of shukrakshaya with semen sample suggestive of oligospermia. |
|
| ExclusionCriteria |
| Details |
1)Patient with diseases like varicocele in scrotum,hydrocele etc
2)Sexually transmitted disease
3)All congenital cases of impotency(As klaibya in ayurvedic texts)
4)Post surgical complications and traumatically injured condition of genital organs. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in signs and symptoms of shukrakshaya and increase in sperm concentration |
18 month
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparing semen analysis report before & after giving shatavaryadi churna for 1 month |
1 month |
|
|
Target Sample Size
|
Total Sample Size="23"
Sample Size from India="23"
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)
|
07/12/2024 |
| 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="6"
Days="0" |
|
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
|
The prevalence rate of oligospermia in India is 21.43%.The need to have children is of great priority in families hence treatment of infertility has become a global concern.Tje couple not able to reproduce experiences the feeling of frustration and disappointment which increase oxidative stress level thereby worsening the condition.In modern science there is no effective treatment available for oligospermia.The primary treatment for shukrakshaya is vrushya chikitsa.Shatavaryadi churna has properties like vrushya, rasayan, bruhan.As previously no study has been done on shatavaryadi churna in shukrakshaya.so it will be helpful in male age group between 25 to 45 years having sign and symptoms of shukrakshaya and low sperm concentration.Written informed consent will be taken to ensure compliance and transparency in research process.The sample size calculated is 23 by sample size formula.Simple random sampling technique will be used.It is a single ram study.All SOP of churna will be followed throughout the clinical trial.Observation will be done after semen analysis report.Result will be drawn on the basis of assessment criteria.Statistical discussion will be done on the basis of observation and result obtained during treatment.Summary will be drawn,and thesis will be summarized with the help of statistical analysis.Conclusion will be drawn. |