| CTRI Number |
CTRI/2025/10/095670 [Registered on: 07/10/2025] Trial Registered Prospectively |
| Last Modified On: |
03/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To find the effect of Kanchanar Guggulu and Bala Taila in the form of Uttar Basti in Prostatomegaly |
|
Scientific Title of Study
|
A Clinical Evaluation of Kanchanar Guggulu and Bala Taila in the management of Mutraashtila w.s.r To Benign Prostate Hyperplasia (BPH) |
| 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 Aditya Vinod Trivedi |
| Designation |
PG Scholar |
| Affiliation |
Shri Babu Singh Jay Singh Ayurvedic Medical College Farrukhabad |
| Address |
Room Number 315 PG room Division 2 Department of PG studies of Shalya Tantra Shri Babu Singh Jay Singh Ayurvedic Medical College Farrukhabad Bhaupur Bewar Road Farrukhabad
Farrukhabad
UTTAR PRADESH
209625
India |
| Phone |
8237574556 |
| Fax |
|
| Email |
adityatrivedi261@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravindra Varma |
| Designation |
Professor and HOD |
| Affiliation |
Shri Babu Singh Jay Singh Ayurvedic Medical College Farrukhabad |
| Address |
Room Number 314 HOD chamber Division 1 Department of PG studies of Shalya Tantra Shri Babu Singh Jay Singh Ayurvedic Medical College Farrukhabad Bhaupur Bewar Road Farrukhabad
Farrukhabad
UTTAR PRADESH
209625
India |
| Phone |
9036563856 |
| Fax |
|
| Email |
ravivarma3856@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aditya Vinod Trivedi |
| Designation |
PG Scholar |
| Affiliation |
Shri Babu Singh Jay Singh Ayurvedic Medical College Farrukhabad |
| Address |
Room Number 315 PG room Division 2 Department of PG studies of Shalya Tantra Shri Babu Singh Jay Singh Ayurvedic Medical College Farrukhabad Bhaupur Bewar Road Farrukhabad
UTTAR PRADESH
209625
India |
| Phone |
8237574556 |
| Fax |
|
| Email |
adityatrivedi261@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Aditya Vinod Trivedi |
| Address |
Shri Babu Singh Jay Singh Ayurvedic Medical College Farrukhabad Bhaupur Bewar Road Farrukhabad Uttar Pradesh |
| 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 |
| Dr Aditya Trivedi |
Shalya Tantra OPD Shri Babu Singh Jay Singh Ayurvedic Medical College and Hospital |
Room no 314, Division 2, bewar road, fatehgarh Farrukhabad
Farrukhabad
UTTAR PRADESH |
8237574556
adityatrivedi261@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| shri babu singh jay singh ayurvedic medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N398||Other specified disorders of urinary system. Ayurveda Condition: MUTRAJATHARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kanchanar Guggulu, Reference: Sharangdhar Samhita Madhyam Khanda Adhyay 7/95-100, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: Luke Warm Water), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Bala Taila, Reference: Vaidya Bhaskar Vishwanath Gokhale Chikitsa Pardeep Vatavyadhi P-36, Route: Urethral, Dosage Form: Taila, Dose: 50(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Male |
| Details |
Subject with signs and symptoms of Mootrasteela (BPH), Age Group 50-80yrs, BPH as per the International Prostate Symptom Score Index, USG s/o Increased Size Post Void Residual Urine
|
|
| ExclusionCriteria |
| Details |
Age above 40 years and above 70 years.
Patients of CA rectum, CA anal canal, CA prostrate CA bladder, CA penis, Fournier’s gangrene, cystitis, Hypoepispadias, Chronic Kidney Disease/ Acute Kidney Disease or any abdomino-pelvic pathology other than BPH.
Systemic diseases like Uncontrolled Diabetes Mellitus will be excluded, Bleeding disorder, Hematuria. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Patient of BPH may get relief with Kanchanar Guggulu or Bala Taila. |
kanchanar Guggulu may show effect in 4 weeks and bala taila may show effect in or below 4 weeks in BPH |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient may get relief from BPH with the use of Kanchanar Guggulu faster than Bala Taila |
Patient taking Kanchanar Guggulu may get relieve in 4 weeks while with Bala Taila in 6 to 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 1 |
|
Date of First Enrollment (India)
|
15/10/2025 |
| 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="0"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - None of the above
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [adityatrivedi261@gmail.com].
- For how long will this data be available start date provided 20-11-2025 and end date provided 20-02-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
A group of 2 where in 20 patients diagnosed with BPH in each group of Age group 50 to 80 yrs will be selected for the study. Group 1 will be given Kanchanar Guggulu and Group 2 will be given Bala Taila Uttar basti and results will be compared as per the statistical analysis. |