| CTRI Number |
CTRI/2024/03/064563 [Registered on: 20/03/2024] Trial Registered Prospectively |
| Last Modified On: |
18/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ayurvedic management of Kshinshukra with Gokshuradi Vati and Ashwagandhadi Taila Uttarabasti. |
|
Scientific Title of Study
|
Efficacy of Gokshuradi Vati orally with and without administration of Ashwagandhadi tail Uttarbasti in the mangement of Kshinashukra (Oligospermia)-a open labelled randamized clinical camparative clinical trial |
| Trial Acronym |
nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Digvijay Tanaji Patil |
| Designation |
M.D. Scholer |
| Affiliation |
Institute of Teaching and Research in Ayurveda Jamnagar |
| Address |
Department of Kayachikitsa 4th floor academic building ITRA Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
8788582935 |
| Fax |
|
| Email |
digvijaypatil31770@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Charmi S Mehta |
| Designation |
Lecture |
| Affiliation |
Institute of Teaching and Research in Ayurveda Jamnagar |
| Address |
Department of Kayachikitsa 4th floor academic building ITRA Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9428862264 |
| Fax |
|
| Email |
csmehta@itra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Digvijay Patil |
| Designation |
M.D. Scholer |
| Affiliation |
Institute of Teaching and Research in Ayurveda Jamnagar |
| Address |
Department of Kayachikitsa 4th floor academic building ITRA Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
8788582935 |
| Fax |
|
| Email |
digvijaypatil31770@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Teaching and Research in Ayurveda |
|
|
Primary Sponsor
|
| Name |
Institute of Teaching and Research in Ayurveda |
| Address |
Institute of Teaching and Research in Ayurveda, Opp City B division
Police station, Gurudwara road, Jamnagar, 361008, Gujarat, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Digvijay Tanaji Patil |
PG hospital OPD NO.13 INSTITUTE OF TEACHING AND RESEARCH IN AYURVEDA JAMNAGAR |
Department of Kayachikitsa 4th floor academic building ITRA Jamnagar, Opp City B division
Police station, Gurudwara road, Jamnagar, 361008, Gujarat, India
Jamnagar
GUJARAT |
8788582935
digvijaypatil31770@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Institute of Teaching and Research of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N461||Oligospermia. Ayurveda Condition: Kshinshukra, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Gokshuradi Vati, Reference: Asthanga Hridya, Uttara Tantra, Rasayana Adhyaya, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Ashwagandhadi Taila , Reference: Chakradatta Vatavyadhi Adhyaya, Route: Urethral, Dosage Form: Taila, Dose: 20(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: | | 3 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Gokshuradi Vati, Reference: Asthanga Hridya, Uttara Tantra, Rasayana Adhyaya, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -Godugdha), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Male |
| Details |
1 Male patients with age between 21 to 40 years
2 Patients having Sperm count less than 15 million per ml According to WHO 2021 and or Low sperm motility less than 50 percent SLP Sperm like particles
3 Patient with or without clinical presentation of Kshinashukra Daurbalya, Mukhashosha
|
|
| ExclusionCriteria |
| Details |
1 Patients with sperm count more than 15 million per ml
2 Patients with age below 21 and above 40 years
3 Patients of aspermia and azoospermia
4 Patients suffering from Varicocele, accessory sex gland infection, STD, Systemic diseases like chronic renal failure CRF, Uncontrolled Hypertension BP more than150per90 mmHg, Diabetes mellitus RBS more than140 mg per dl
5 Genetic disorders like Klinfelter syndrome.
6 Patients taking treatment for major psychiatric illness
7 History of previous medication and trauma leading to oligospermia
8 Patients having Hematuria Blood in the urine, Chronic Cystitis, UTI, Kidney Stone, Bladder Stones
9 Known case of Cardiac Diseases History of Myocardial infraction, Ischemic heart disease
10 Patient suffering from Urethral Stricture, Phimosis, Meatal Stenosis, Hypospadiasis, Epispadiasis.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To increase sperm count and sperm motility of patient of Kshinashukra. |
Group A- 16 weeks
Group B- 16 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To treat infertility due to male factor and have healthy progeny.
2 To improve the quality of life of infertile couple.
|
02 month |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/05/2024 |
| Date of Study Completion (India) |
27/10/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 trial is randomized clinical trial to evaluate the role of Gokshuradi vati orally with and without administration of Ashwagandhadi Taila Uttarabasti in the management of kshinshukra(Oligospermia). Total 30 patient will be enrolled in the study. Selected patient will be divided into 2 groups on the basis of computer-generated randomization. In this study Gokshuradi vati 4 tab. BD before meal each of 500mg will be given orally with anupan of godugdha for 8 weeks and Ashwagandhadi taila uttarbasti 20ml early morning for 14 days.In another group Gokshuradi vati 4tab.BD before meal orally with anupana of godugdha each of 500mg.for 8 weeks. follow-ups will be carried out at 15 days interval for 2month after treatment. |