| CTRI Number |
CTRI/2026/02/104012 [Registered on: 16/02/2026] Trial Registered Prospectively |
| Last Modified On: |
16/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Chandana Taila Uttarabasti for Prostate Cancer: A Clinical Study |
|
Scientific Title of Study
|
A RANDOMISED CONTROL CLINICAL STUDY TO EVALUATE THE EFFICACY OF CHANDANA TAILA UTTARBASTI IN MANAGEMENT OF PROSTATE CANCER |
| 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 Priyansh Chaudhary |
| Designation |
PG scholar |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Department of Shalya Tantra, Parul Institute of Ayurved, Parul University, Limda, Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9427603200 |
| Fax |
|
| Email |
rajkchaudhary838@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hemant Toshikhane |
| Designation |
Professor,Department of Shalya Tantra |
| Affiliation |
Parul Institute of Ayurved |
| Address |
106, Shalya Tantra OPD, Parul Ayurved Hospital, Parul University, Limda, Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
8469496525 |
| Fax |
|
| Email |
hemant.toshikhane@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hemant Toshikhane |
| Designation |
Professor,Department of Shalya Tantra |
| Affiliation |
Parul Institute of Ayurved |
| Address |
106, Shalya Tantra OPD, Parul Ayurved Hospital, Parul University, Limda, Vadodara
GUJARAT
391760
India |
| Phone |
8469496525 |
| Fax |
|
| Email |
hemant.toshikhane@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| Parul Institute of Ayurved |
|
|
Primary Sponsor
|
| Name |
Parul Ayurved Hospital |
| Address |
Shalya Tantra-OPD No.106 and IPD, Parul Ayurved Hospital, Parul Institute Of Ayurved, Parul
University, Limda, Tal. Waghodia-391760, Dist-Gujarat |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Priyansh Chaudhary |
Parul Ayurved Hospital |
Shalya Tantra OPD No. 106, Parul Ayurved
Hospital, Parul University, Limda,Vadodara391760
Vadodara
GUJARAT |
9427603200
priyanshc411@gmail.com |
| Dr Priyansh Chaudhary |
Pramukh cancer hopsital |
A1 Block,Ground Floor,
Medipolis, Deesa - Palanpur Hwy,Palanpur
Banas Kantha
GUJARAT |
9427603200
rajkchaudhary838@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PARUL AYURVED INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:C61||Malignant neoplasm of prostate. Ayurveda Condition: ASHTHILIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: chandna Taila, Reference: NA, Route: Urethral, Dosage Form: Taila, Dose: 30(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 2 Weeks, anupAna/sahapAna: Yes(details: -), Additional Information: -Chandana Taila 30 ml uttarbasti will be given into urethral route for 2 times a week for 10 weeks |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Male |
| Details |
1. Males aged between 40 and 75 years
2. Diagnosed with prostate cancer (Stage I or II or III) based on clinical and radiological findings.
3. Willing to undergo Uttarbasti treatment and provide informed consent.
|
|
| ExclusionCriteria |
| Details |
1. Metastatic stage (Stage IV) prostate cancer
2. Patients with uncontrolled diabetes, hypertension, or serious systemic illnesses
3. Active rectal disorders (fistula, fissure, piles)
4. Those undergoing surgery during the study period
5. Known allergy to ingredients of Chandana Taila |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in serum PSA levels from baseline to completion of treatment. |
10 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in urinary and quality-of-life parameters assessed by EPIC questionnaire; radiological changes in prostate; safety and tolerability of Chandana Taila Uttarabasti. |
10 WEEKS |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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 |
|
Date of First Enrollment (India)
|
03/03/2026 |
| 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="5"
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
|
Prostate cancer is one of the most common cancers affecting men and often leads to urinary symptoms and reduced quality of life. Conventional treatments such as chemotherapy and radiotherapy may cause significant side effects, especially in elderly patients. Therefore, there is a need to explore supportive and integrative treatment approaches that may help improve patient outcomes and well-being.
This randomized controlled clinical study is designed to evaluate the efficacy and safety of Chandana Taila Uttarabasti as a supportive Ayurvedic intervention in patients with prostate cancer. Eligible patients will be randomly allocated into two groups. One group will receive standard oncological care, while the other group will receive standard care along with Chandana Taila Uttarabasti. The intervention will be administered over a period of five months.
The primary outcome of the study is the change in serum PSA levels from baseline to the end of treatment. Secondary outcomes include improvement in urinary symptoms, quality of life assessed using standardized questionnaires, radiological findings, and assessment of safety and tolerability. The results of this study may help in understanding the role of Chandana Taila Uttarabasti as a supportive therapy in the management of prostate cancer. |