| CTRI Number |
CTRI/2023/11/060069 [Registered on: 21/11/2023] Trial Registered Prospectively |
| Last Modified On: |
20/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of Healature spray versus Oxum spray in Fistulectomy wound |
|
Scientific Title of Study
|
Evaluation of comparative efficacy of Healature spray versus Oxum spray in the management of Fistulectomy wound(RCT) |
| 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 Dhruv Bhadreshbhai Modi |
| Designation |
PG Scholar |
| Affiliation |
Datta Meghe Institute of Higher Education & Research |
| Address |
Room no. 13 Shalyatantra OPD Mahatma Gandhi Ayurved College Hospital & Research Centre
Wardha
MAHARASHTRA
442001
India |
| Phone |
9426691684 |
| Fax |
|
| Email |
modidhruv1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Devyani Dasar |
| Designation |
Associate Professor |
| Affiliation |
Datta Meghe Institute of Higher Education & Research |
| Address |
Room no. 13 Shalyatantra OPD Mahatma Gandhi Ayurved College Hospital & Research Centre
Wardha
MAHARASHTRA
442001
India |
| Phone |
9503630392 |
| Fax |
|
| Email |
devyani.dasar@dmiher.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Devyani Dasar |
| Designation |
Associate Professor |
| Affiliation |
Datta Meghe Institute of Higher Education & Research |
| Address |
Room no. 13 Shalyatantra OPD Mahatma Gandhi Ayurved College Hospital & Research Centre
Wardha
MAHARASHTRA
442001
India |
| Phone |
9503630392 |
| Fax |
|
| Email |
devyani.dasar@dmiher.edu.in |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Ayurveda College Hospital & Research Centre |
|
|
Primary Sponsor
|
| Name |
Dr Dhruv Bhadreshbhai Modi |
| Address |
Mahatma Gandhi Ayurveda College Hospital & Research Centre |
| Type of Sponsor |
Other [Self] |
|
|
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 Dhruv Bhadreshbhai Modi |
Mahatma Gandhi Ayurved College Hospital & Research Centre |
OPD & IPD of Dept of Shalyatantra MGACH&RC Salod Hirapur Wardha
Wardha
MAHARASHTRA |
9426691684
modidhruv1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma Gandhi Ayurved College Hospital & Research Centre Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Healature spray, Reference: NA, Route: Topical, Dosage Form: Sprays, Dose: 3(ml), Frequency: bd, Bhaishajya Kal: Sabhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Oxum spray | Hypochlorus acid, Oxidised water, Route: Topical,
Dose: 3ml, Frequency: bd, Duration: 14days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of both the sexes in
between the age group of 18 to 60
years.
Patients irrespective of gender,
religion, occupation and economic
status.
Complete fistulectomy wounds of
length 1-3 cm will be included in
this study.
Patients with controlled
hypertension and diabetes
mellitus. |
|
| ExclusionCriteria |
| Details |
Patients having Fistula in ano
secondary to Ulcerative colitis,
Syphilis, Crohn’s disease,
Tuberculosis and malignancy of
rectum and anal canal.
Pregnant females
HIV& HbsAg positive patients
Skin diseases |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fistulectomy wound healing |
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| relief in pain, reduces itching |
14 days |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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="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 volunteers will be informed about the study protocol. willing participant will be randomly selected as per computer generated table. Clinical research format will be prepared and validated. Prior to the study approval will be taken from IEC, MGACHRC, Salod(H), Wardha and CTRI registration will be done. After selection ,each participant will be tested individually and selected according to selection criteria. they will be divided into two groups as the trial is a parallel group, randomized, open clinical, standard controlled trial. it will include a 16 days treatment period and follow up. |