| CTRI Number |
CTRI/2025/07/090497 [Registered on: 08/07/2025] Trial Registered Prospectively |
| Last Modified On: |
18/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Clinical study to evaluate the efficacy of Dasamooladi kwath and Dhanyaka Gokshura ghreeta Matra basti in the management of vatasthila with special reference to benign prostate hyperplasia |
|
Scientific Title of Study
|
Clinical study of Dasamooladi kwath and Dhanyaka Gokshura ghreeta Matra basti in the management of vatasthila with special reference to benign prostatic hyperplasia |
| 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 Abdul Khaleque |
| Designation |
Post graduate scholar |
| Affiliation |
Govt Ayurvedic College Hospital Guwahati 14 |
| Address |
Govt Ayurvedic College Hospital Guwahati
Jalukbari Guwahati 781014
Kamrup
ASSAM
781014
India |
| Phone |
8099034056 |
| Fax |
|
| Email |
dr.khaleque.abdul4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shyamanta Kalita |
| Designation |
Associate Professor and Guide |
| Affiliation |
Govt Ayurvedic College and Hospital Guwahati |
| Address |
Dept of Kayachikitsa Govt Ayurvedic College and Hospital Guwahati
Kamrup
ASSAM
781014
India |
| Phone |
9707186463 |
| Fax |
|
| Email |
kalitashyamanta108@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Binod kalita |
| Designation |
Assistant professor and co Guide |
| Affiliation |
Govt Ayurvedic College and Hospital Guwahati |
| Address |
Dept of shalya tantra Govt Ayurvedic College and Hospital
Kamrup
ASSAM
781014
India |
| Phone |
7002675408 |
| Fax |
|
| Email |
Dr.binodkalita75@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt Ayurvedic College and Hospital Guwahati-781014 |
| Nil |
|
|
Primary Sponsor
|
| Name |
Dr Abdul khaleque |
| Address |
Government Ayurvedic college and Hospital Guwahati 781014 |
| Type of Sponsor |
Other [Self] |
|
|
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 Abdul Khaleque |
Government Ayurvedic college and Hospital Guwahati 781014 |
OPD and IPD of Department of Kayachikitsa Government Ayurvedic college and Hospital jalukbari guwahati 781014
Kamrup
ASSAM |
8099034056
dr.khaleque.abdul4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee Government Ayurvedic College and Hospital Guwahati 781014 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N400||Benign prostatic hyperplasia without lower urinary tract symptoms. Ayurveda Condition: VATASHTHILA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: Bhaisajya Ratnavali Mutraghat Chikitsa chapter 35, Procedure details: Matra Basti)
(1) Medicine Name: Dhanyaka Gokshura Ghrita , Reference: Bhaisajya Ratnavali Mutraghat Chikitsa chapter 35, Route: Rectal, Dosage Form: Ghrita, Dose: 75(ml), Frequency: od, Duration: 15 Days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Dasamooladi kwath , Reference: Yogratnakar Mutraghat chikitsa chapter 53, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: - | | 3 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Dasamooladi kwath & Dhanyaka Gokshura Ghrita , Reference: Yogratnakar Mutraghat Chikitsa chapter 53 and bhaisajya Ratnavali Mutraghat Chikitsa chapter 35, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: -Dasamooladi kwath orally and Dhanyaka Gokshura ghrita Matra Basti |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Male |
| Details |
Patient diagnosed on the basis of LUTs on digital Rectal examination of enlarged prostate
USG suggestive of BPH upto grade three
Patient with considerable PSA level |
|
| ExclusionCriteria |
| Details |
Patient with grade four BPH
Patient with high PSA
Patient with systemic disorders like uncontrolled diabetes mellitus CKD ClD cardiac illness
HIV positive Hepatitis B,C and A positive cases with other STDs
Patient with other cause of LUTS like neurogenic bladder urethral stricture |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To asses the effectiveness of Dasamooladi kwath and Dhanyaka Gokshura ghreeta Matra basti in the management of symptomatology of vatasthila (BPH) |
30days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the combined efficacy of Dasamooladi kwath and Dhanyaka Gokshura ghreeta Matra basti in management of vatasthila |
45 days , 60days |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
15/07/2025 |
| 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 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 clinical study to evaluate the combined efficacy of Dasamooladi kwath and Dhanyaka Gokshura ghrita Matra basti in the management of Vatasthila. This study is done as a mandatory Post-graduation thesis work .Total number of 60 patient Will be studied for 60 days each |