| CTRI Number |
CTRI/2025/07/091491 [Registered on: 23/07/2025] Trial Registered Prospectively |
| Last Modified On: |
22/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To conduct study on- An Evaluation of efficacy of Vijayaraj Marham (Canabryl Rectal Suppositories) for pain management in Terminally ill cancer patients as an adjuvant therapy. |
|
Scientific Title of Study
|
To conduct Pilot study on- An Evaluation of efficacy of Vijayaraj Marham (Canabryl Rectal Suppositories) for pain management in Terminally ill cancer patients as an adjuvant therapy. |
| Trial Acronym |
Ayurvedic drug. |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kuldeep Kumar Pandey |
| Designation |
Professor and Head Dept of Sangyaharan |
| Affiliation |
Institute of Medical science Banaras Hindu University |
| Address |
Department of Sangyaharan, Institute of Medical Sciences, Banaras Hindu University, Varanasi
Department of Sangyaharan, Institute of Medical Sciences, Banaras Hindu University, Varanasi.
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
09415251556 |
| Fax |
|
| Email |
pandeykk@bhu.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Kuldeep Kumar Pandey |
| Designation |
Professor and Head Dept of Sangyaharan |
| Affiliation |
Institute of Medical science Banaras Hindu University |
| Address |
Department of Sangyaharan, Institute of Medical Sciences, Banaras Hindu University, Varanasi
Department of Sangyaharan, Institute of Medical Sciences, Banaras Hindu University, Varanasi.
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
09415251556 |
| Fax |
|
| Email |
pandeykk@bhu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Kuldeep Kumar Pandey |
| Designation |
Professor and Head Dept of Sangyaharan |
| Affiliation |
Institute of Medical science Banaras Hindu University |
| Address |
Department of Sangyaharan, Institute of Medical Sciences, Banaras Hindu University, Varanasi
Department of Sangyaharan, Institute of Medical Sciences, Banaras Hindu University, Varanasi.
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
09415251556 |
| Fax |
|
| Email |
pandeykk@bhu.ac.in |
|
|
Source of Monetary or Material Support
|
| IMS Banaras Hindu University Varanasi |
|
|
Primary Sponsor
|
| Name |
Institute of Medical Science |
| Address |
Department of Sangyaharan IMS BHU |
| 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 |
| Kuldeep Kumar Pandey |
Banaras Hindu University |
Department of Sangyaharan, Institute of Medical Sciences, Banaras Hindu University, Varanasi.
Varanasi
UTTAR PRADESH |
09415251556
pandeykk@bhu.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K918||Other intraoperative and postprocedural complications and disorders of digestive system. Ayurveda Condition: ARSO-, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vijayraj Marham, Reference: Dravyaguna, Route: Rectal, Dosage Form: Varti/ Suppository, Dose: 1(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 1 Days, anupAna/sahapAna: No, Additional Information: NA |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Day(s) |
| Age To |
50.00 Day(s) |
| Gender |
Both |
| Details |
ASA Grade 1-3 posted for Anorectal surgery(piles and fistula)under Spinal and local Anaesthesia. |
|
| ExclusionCriteria |
| Details |
1.Sensitivity to local anaesthetics.
2.Age below 30 years and above 50 years.
3.Any pre existing disease like DM HTN Thyroid disorder.
4.Any spinal deformity. |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief from surgical pain. |
Relief from surgical pain. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To notice duration of analgesia & untoward effect if any. |
Twenty four hours. |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
10/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/08/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
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
|
To assess the pilot study on -Vijayraj Marham (Canabryl Rectal suppositories)for the post operative pain management in patient of Anorectal surgery (Piles Fistula). |