| CTRI Number |
CTRI/2025/07/091493 [Registered on: 23/07/2025] Trial Registered Prospectively |
| Last Modified On: |
22/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
pilot study to evaluate the effect of Vijay extract for pain relief in cancer patients receiving palliative care |
|
Scientific Title of Study
|
to conduct Pilot study on - an evaluation of vijaya extract (canabryl full spectrum) for pain management in cancer patients as an adjuvant therapy in palliative care |
| 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 K K Pandey |
| Designation |
professor |
| Affiliation |
Banaras Hindu University, Varanasi |
| Address |
Department of Sangyaharn, Dhanwantri bhavan, Faculty of Ayurveda, IMS, BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9415251556 |
| Fax |
|
| Email |
pandeykk@bhu.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K K Pandey |
| Designation |
professor |
| Affiliation |
Banaras Hindu University, Varanasi |
| Address |
Department of Sangyaharn, Dhanwantri bhavan, Faculty of Ayurveda, IMS, BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9415251556 |
| Fax |
|
| Email |
pandeykk@bhu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr K K Pandey |
| Designation |
professor |
| Affiliation |
Banaras Hindu University, Varanasi |
| Address |
Department of Sangyaharn, Dhanwantri bhavan, Faculty of Ayurveda, IMS, BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9415251556 |
| Fax |
|
| Email |
pandeykk@bhu.ac.in |
|
|
Source of Monetary or Material Support
|
| Banaras Hindu University Varanasi 221005 UP India |
|
|
Primary Sponsor
|
| Name |
Banaras Hindu University Varanasi UP India |
| Address |
Department of Sangyaharan Dhanwantri Bhavan IMS BHU Varanasi 221005 UP India |
| Type of Sponsor |
Government 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 K K Pandey |
Banaras Hindu University |
Department of Sangyaharn, Dhanwantri bhavan, Faculty of Ayurveda, IMS, BHU
Varanasi
UTTAR PRADESH |
09415251556
pandeykk@bhu.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G00-G99||Diseases of the nervous system. Ayurveda Condition: ARBUDAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: vijaya extract, Reference: ayurveda, Route: Oral, Dosage Form: Sattva, Dose: 20(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: gau ghrita), Additional Information: - | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Tramodal, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 50(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
confirm diagnosis of cancer, stable medical condition |
|
| ExclusionCriteria |
| Details |
Coronary artery disease, thyroid, diabetic, asthama etc |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sample size is 60, and the primary outcome after intervention was 30 |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Numerical Rating Scale using visual analog scale (VAS) |
After 3 months |
|
|
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 3 |
|
Date of First Enrollment (India)
|
10/08/2025 |
| 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="3"
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
|
Pain management after cancer treatment is a vital part of survivorship care. Even after successful treatment, many cancer survivors experience persistent or chronic pain due to treatment-related side effects, surgery, nerve damage, or ongoing inflammation. |