| CTRI Number |
CTRI/2025/05/086124 [Registered on: 01/05/2025] Trial Registered Prospectively |
| Last Modified On: |
01/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic
Preventive
Screening
Other (Specify) [Urethral root uttar basti] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To Evaluate the Combined effect of KAKOLYADI TAILA UTTAR BASTI & SHALMALIMULA GRANULES in male Shukra Dusti
|
|
Scientific Title of Study
|
CLINICAL STUDY TO EVALUATE
THE ROLE OF KAKOLYADI TAILA UTTAR BASTI & SHALMALIMULA
GRANULES IN SHUKRA-DUSTI |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ramveer Singh Meena |
| Designation |
M.S. Scholar, Prasuti tantra evum Stri Roga Deptt. |
| Affiliation |
PGIA, Jodhpur |
| Address |
PG Department of Prasuti Tantra evum Stri Roga,Post Graduate Institute of Ayurveda Dr Sarvepalli Radhakrishnan Rajasthan Ayurveda University Jodhpur Rajasthan
Jodhpur
RAJASTHAN
342037
India |
| Phone |
6378299651 |
| Fax |
|
| Email |
drrsmeena89@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rashmi Sharma |
| Designation |
Associate Professor |
| Affiliation |
PGIA , Jodhpur |
| Address |
PG Department of Prasuti Tantra evum Stri Roga,Post Graduate Institute of Ayurveda Dr Sarvepalli Radhakrishnan Rajasthan Ayurveda University Jodhpur Rajasthan
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9166607559 |
| Fax |
|
| Email |
vd_rashmi11@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ramveer Singh Meena |
| Designation |
M.S. Scholar |
| Affiliation |
PGIA, Jodhpur |
| Address |
PG Department of Prasuti Tantra evum Stri Roga,Post Graduate Institute of Ayurveda Dr Sarvepalli Radhakrishnan Rajasthan Ayurveda University Jodhpur Rajasthan
Jodhpur
RAJASTHAN
342037
India |
| Phone |
6378299651 |
| Fax |
|
| Email |
drrsmeena89@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Ayurveda Dr Sarvepalli Radhakrishnan Rajasthan Ayurveda University Jodhpur PIN 342037 Rajasthan |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Ayurveda DSRRAU Jodhpur Rajasthan |
| Address |
Post Graduate Institute of Ayurveda Dr Sarvepalli Radhakrishnan Rajasthan Ayurveda University Jodhpur Rajasthan Pin code 342037 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Ramveer Singh Meena |
PG Department of Prasuti Tantra evum Stri Roga,Post Graduate Institute of Ayurveda, Dr Sarvepalli Radhakrishnan Rajasthan Ayurveda University Jodhpur Rajasthan |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ramveer Singh Meena |
PGIA Jodhpur |
PG Department of Prasuti Tantra evum Stri Roga,Post Graduate Institute of Ayurveda Dr Sarvepalli Radhakrishnan Rajasthan Ayurveda University Jodhpur Rajasthan
Jodhpur
RAJASTHAN |
06378299651
drrsmeena89@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Post Graduate Institute of Ayurveda Jodhpur |
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 | Intervention Arm | Procedure | - | uttara-bastiH, उत्तर-बस्तिः | (Procedure Reference: Charak Siddhi 10/28, Procedure details: Kakolyadi tail 20 ml/ day for 3 consecutive
days followed by gap of 3 days given by male urethral route.
(2 Sitting in a month ) )
(1) Medicine Name: Shalmali Granules, Reference: Bhaisajya ratnawali 74/19, Route: Oral, Dosage Form: Khanda/Granules, Dose: 7(g), Frequency: bd, Duration: 2 Months |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Male |
| Details |
Male patients suffering from Shukra- Dusti.
Patients with clinical presentation of Shukra- Dusti were selected.
Patients fit for Basti Karma. |
|
| ExclusionCriteria |
| Details |
Patients suffering from genetic disorders such as Klinefelters syndrome.
Patients undergoing treatment for major psychiatric illness.
Patients suffering from varicocele, accessory sex gland infection.
Patients of Pyospermia and necrospermia.
Sexually transmitted disease.
Severe systemic disease etc.
Any history of previous trauma leading to Male genital organ.
Patients having history of Diabetes mellitus. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
ASSESSMENT of -
1.Sperms Count
2.Sperms Motility
3.Sperms Volume |
60 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in -
1.Daurbalya
2.Mukhashosha
3.Sexual desire
4.Erection
5.Ejaculation
6.Self-satisfaction
7.Performance anxiety
8.Post act exhaustion
9.Partner satisfaction
|
60 Days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
02/06/2025 |
| 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="1"
Months="0"
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
|
This is single group an Clinical Study to Evaluate the Role of Kakolyadi Taila Uttar Basti & Shalmalimula Granules in Shukra-Dusti. Male patients age (20-50 years) having infertility as a result of Sperm Count and Motality, diagnosed by Seemen analysis and Failure to help conceive female partner within one or more year of regular unprotected coitus and Patients having age group < 20years and > 50 years, Infertility due to other factor like injury or surgery in external or internal genitalia, any genetic disorders, psychiatric illness, Pyospermia, Necrospermia. and Patient suffering from chronic diseases like Diabetes mellitus, Hypertension, Tuberculosis Malignancy, Thyroid disorder, Severe anaemia etc. and Patient suffering from Hepatitis B, sexually transmitted diseases, human immunodeficiency virus (HIV), Congenital anatomical defect of male genital organ. Kakolyadi tail 20 ml/ day for 3 consecutive days followed by gap of 3 days (2 Sitting in a month ) Shalmali mula granules 8 to 10 gm Two-time in a day. |