| CTRI Number |
CTRI/2023/07/055244 [Registered on: 14/07/2023] Trial Registered Prospectively |
| Last Modified On: |
13/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Post operative fissure in ano pain |
|
Scientific Title of Study
|
A clinical evaluation of analgesic effect of Vednasthapan Vati and Vednasthapan ointment in the management of post operative fissure in ano pain |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hemant Kumawat |
| Designation |
PhD Scholar |
| Affiliation |
University Post Graduate Institute Of Ayurveda Studies & Research Jodhpur Rajasthan |
| Address |
Department of Shalya Tantra Punjab Ayurved Medical College and Hospital Morjandkhari Sadulshahar Hanumangarh Road
Ganganagar
RAJASTHAN
335037
India |
| Phone |
9887145554 |
| Fax |
|
| Email |
hemant.kumawat598@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Rajesh Kumar Gupta |
| Designation |
Professor & HOD |
| Affiliation |
University Post Graduate Institute Of Ayurveda Studies & Research Jodhpur Rajasthan |
| Address |
Department of Shalya Tantra UPGIAS and R Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Kadvad Nagaur Road
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9636520573 |
| Fax |
|
| Email |
Guptadrrajeshkumargupta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Rajesh Kumar Gupta |
| Designation |
Professor & HOD |
| Affiliation |
University Post Graduate Institute Of Ayurveda Studies & Research Jodhpur Rajasthan |
| Address |
Department of Shalya Tantra UPGIAS and R Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Kadvad Nagaur Road
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9636520573 |
| Fax |
|
| Email |
Guptadrrajeshkumargupta@gmail.com |
|
|
Source of Monetary or Material Support
|
| University Post Graduate Institute Of Ayurveda Studies and Research DSRRAU Jodhpur Rajasthan 342037 |
|
|
Primary Sponsor
|
| Name |
University Post Graduate Institute of Ayurveda Studies and Research DSRRAU Jodhpur |
| Address |
Kadvad Nagaur Road 342037 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Hemant Kumawat |
Punjab Ayurved Medical Hospital |
OPD and IPD Ward No. 1 and 2 of Shalya Tantra Department
Ganganagar
RAJASTHAN |
9887145554
hemant.kumawat598@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. SarvepalliRadhakrishnan Rajasthan Ayurved University, Jodhpur Post Graduate Institute of Ayurved Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K602||Anal fissure, unspecified. Ayurveda Condition: PARIKARTIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vednasthapan ointment, Reference: Charak Samhita Sutra Sthan 4/8(49), Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 1(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: Vednasthapan Vati, Reference: Charak Samhita Sutra Sthan 4/8(49), Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Ushnodak), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Operated Patients with fissures in the ano complaining of pain in the anal region |
|
| ExclusionCriteria |
| Details |
Patients suffering from other systemic and metabolic diseases like Diabetes mellitus, tuberculosis, AIDS, Hepatitis, Anaemia, Chronic renal failure, and Uncontrolled Hypertension
Patients operated for fissures in ano along with fistula, piles, and other ano rectal diseases
Patients Having carcinoma of the rectum and carcinoma of the anal canal |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in the post operative fissure in ano pain |
Till 28 days from the day of enrollment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improve quality of life of the patient & research alternative analgesic ayurvedic drug with minimal side effects |
After 56 days from the day of enrollment |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
01/08/2023 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
The trial will be initiated with the aim & objective of evaluating the significance of the Vedna Shamak effect of Vednasthapan Vati clinically orally and Vednasthapan ointment local application upon post-operative fissure wound in the management of pain in the anal region In this study total of 50 patients will be enrolled in a single-arm group All 50 patients will be managed with Vednasthapan Vati 500mg orally with lukewarm water twice a day after a meal and the local application of Vednasthapan ointment 1g upon the post-operative fissure in the anal region wound once a day for 28 days from the first postoperative day Each patient will be observed for changes in the intensity and duration of pain every 7th day continuously for 28 days from the first day after post operation The same shall be recorded in the clinical Proforma case sheets for the study A total of two follow-ups every 14th days after the trial up to 28 days will be taken |