| CTRI Number |
CTRI/2025/01/079141 [Registered on: 21/01/2025] Trial Registered Prospectively |
| Last Modified On: |
19/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To find out the effect of Kalyanaka kshara with Virataradi kashaya asan adjuvant therapy for improving the quality of life in Prostate cancer |
|
Scientific Title of Study
|
Effect of Kalyanaka kshara with Virataradi kashaya as an adjuvant therapy for improving the quality of life in CA Prostate A pre test post test design |
| 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 Sai Nandana MC |
| Designation |
PG Scholar |
| Affiliation |
VPSV Ayurveda College Kottakkal |
| Address |
Department of Shalyatantra,
VPSV Ayurveda College Kottakkal, Malappuram, Kerala, India
Malappuram
KERALA
676501
India |
| Phone |
7012027202 |
| Fax |
|
| Email |
sainandanamc2018@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr REJANI H |
| Designation |
Professor and HOD |
| Affiliation |
VPSV Ayurveda College Kottakkal |
| Address |
Department of Shalyatantra,
VPSV Ayurveda College Kottakkal, Malappuram, Kerala, India
Malappuram
KERALA
676501
India |
| Phone |
9447270227 |
| Fax |
|
| Email |
drrejaniharidas@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr REJANI H |
| Designation |
Professor and HOD |
| Affiliation |
VPSV Ayurveda College Kottakkal |
| Address |
Department of Shalyatantra,
VPSV Ayurveda College Kottakkal, Malappuram, Kerala, India
KERALA
676501
India |
| Phone |
9447270227 |
| Fax |
|
| Email |
drrejaniharidas@gmail.com |
|
|
Source of Monetary or Material Support
|
| Arya Vaidyashala Kottakkal GMP Certified Institute
Malappuram Kerala
India 676503 |
|
|
Primary Sponsor
|
| Name |
VPSV AYURVEDA COLLEGE KOTTAKKAL |
| Address |
VPSV Ayurveda College Kottakkal Edarikkode PO Kottakkal Kerala
676501 |
| Type of Sponsor |
Other [Aided 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 Sai Nandana M C |
Charitable Hospital |
VPSVs Arya Vaidyashala Special OPD charitable hospital
OPD room no 3
Kottakkal pin 676503
Malappuram Kerala
Malappuram
KERALA |
7012027202
sainandanamc2018@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE (IEC) VAIDYARATNAM PS VARIER AYURVEDA COLLEGE KOTTAKKAL |
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: ARBUDAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: KALYANAKA KSHARA, Reference: ASHTANGA HRIDAYA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: VIRATARADI KASHAYA, Reference: ASHTANGA HRIDAYA, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 15(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -LUKE WARM WATER), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Male |
| Details |
Subjects diagnosed with CA Prostate,age group of 40-70 year and with informed consent. |
|
| ExclusionCriteria |
| Details |
Uncontrolled DM HbA1c greater than 7.5
HTN BP greater than 150/100 mmHg
Chronic kidney diseases |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improve in quality of life assessed through questionnaire EORTC-QLQ-C-30 and EORTC-QLQ-PR25 |
0th 31st and 61st days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe whether the combination of drug affects the urine pH using urine routine examination |
0th and 61st days |
|
|
Target Sample Size
|
Total Sample Size="11"
Sample Size from India="11"
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)
|
21/02/2025 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Effect of Kalyanaka kshara with Virataradi kashaya as an adjuvant therapy for improving the quality of life in CA Prostate -A pre test -post test design. Prostate cancer is the second most commonly diagnosed cancer globally. The diagnosis as well as the treatment affect both general quality of life and health related specific quality of life including urinary, bowel and sexual domains. The objective of this study is to validate the effect of Kalyanaka kshara with Virataradi kashaya as an adjuvant therapy for improving the quality of life in CA Prostate. The European Organisation for Reasearch and Treatment of Cancer EORTC-QLQ-PR25 is a Prostate cancer specific module, supplementary to the core quality of life questionnaire EORTC-QLQ-C-30, will be used in the study. The study design will be a single group pre test -post test trial. Including 11 participants in the age group of 40 to 70 years selected from the VPSV’s Aryavaidyasala Special OP, Charitable Hospital, Kottakkal. Quality of life assessment of the participants will be done on the 0 th,31st, and 61st days. The data will be analysed using the most appropriate statistical test. |