| CTRI Number |
CTRI/2023/12/060766 [Registered on: 26/12/2023] Trial Registered Prospectively |
| Last Modified On: |
29/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparative evaluation of efficacy of Murivenna Tail Gudapurana as
against Yashtimadhu Ghrita Gudapurana in the management of postoperative pain of Piles and Fissure in ano |
|
Scientific Title of Study
|
Comparative evaluation of efficacy of Murivenna Tail Gudapurana as
against Yashtimadhu Ghrita Gudapurana in the management of postoperative pain of Haemorrhoids and Fissure in ano |
| 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 Ayushi Gautam |
| Designation |
PG Scholar |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Room Number 13 Shalya Tantra OPD Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Hiraur Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
8805514157 |
| Fax |
|
| Email |
ayushigautam0416@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sheetal Asutkar |
| Designation |
Head of Department of Shalyatantra |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Room Number 13 Shalya Tantra OPD Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Hiraur Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9766811974 |
| Fax |
|
| Email |
sheetalasutkar16@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sheetal Asutkar |
| Designation |
Head of Department of Shalyatantra |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Room Number 13 Shalya Tantra OPD Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Hiraur Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9766811974 |
| Fax |
|
| Email |
sheetalasutkar16@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education And Research |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education And Research |
| Address |
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Hirapur Wardha |
| 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 |
| Dr Ayushi Gautam |
Mahatma Gandhi Ayurved College Hospital and Research Centre |
Room Number 13 OPD Shalya Tantra Department Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Hirapur Wardha
Wardha
MAHARASHTRA |
8805514157
ayushigautam0416@gmail.com |
|
|
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:K642||Third degree hemorrhoids. Ayurveda Condition: ARSAH , (2) ICD-10 Condition:K643||Fourth degree hemorrhoids. Ayurveda Condition: ARSAH, (3) 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 | Other than Classical | | (1) Medicine Name: Murivenna taila, Reference: NA, Route: Rectal, Dosage Form: Taila, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 14 Days, Reference: NA, Route: NA, Dosage Form: Taila, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Yashtimadhu ghrita , Reference: Sushruta shamhita , Route: Rectal, Dosage Form: Ghrita, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 14 Days, Reference: No, Route: NA, Dosage Form: Ghrita, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with age group of 20 yrs to 60 yrs.
2. Controlled Diabetes
3. Post-operative patients with clinical feature of fissure in ano and haemorrhoids will be
included after screening irrespective of sex, religion and socioeconomic status.
4. Haemorrhoid Grade 3 & 4 |
|
| ExclusionCriteria |
| Details |
1. Patients suffering with Carcinoma Rectum.
2. Patients undergone LASER anorectal surgery
3. Pregnant and lactating women.
4. Immuno-compromised patients like HIV positive, HbSAg and Tuberculosis patient.
5. Known cases of Anaemia, Anorectal Malignancy, Crohn’s disease, Ulcerative colitis. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Analgesic effect in post operative pain of Haemorrhoids and fissure in ano |
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Wound Healing effect of Drug |
28 days |
|
|
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/ Phase 4 |
|
Date of First Enrollment (India)
|
01/01/2024 |
| 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
|
This study will be carried out on post operative cases of Haemorrhoids and Fissure in ano to see analgesic effect. Murivenna Tail is widely used in South India for Anti-inflammatory, wound healing, Analgesic
properties, etc. It’s use in the form of Gudapurana (anal instillation) in post-operative pain can decrease
the use of NSAIDs, opioids, steroids. |