| CTRI Number |
CTRI/2023/02/049706 [Registered on: 14/02/2023] Trial Registered Prospectively |
| Last Modified On: |
11/02/2023 |
| 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 study of Karanjadi Ghruta, Yasthimadhu Ghruta and Jatyadi Ghruta local application in the Management of Fissure in ano |
|
Scientific Title of Study
|
Evaluation of Comparative Efficacy of Karanjadi Ghruta Pichu, Yasthimadhu Ghruta Pichu and Jatyadi Ghruta Pichu in the Management of Parikartika |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR PRADEEP KUMAR PRADHAN |
| Designation |
PhD student |
| Affiliation |
Datta Meghe Institute of Medical Sciences (Deemed University) Wardha |
| Address |
faculty quater ,Room no. 10 ,Department of Shalya Tantra,
Mahatma Gandhi Ayurved College,
Hospital and Research Center,
Salod, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9907930733 |
| Fax |
|
| Email |
drpradhanpradeep25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SHEETAL ASUTKAR |
| Designation |
PROFESSOR |
| Affiliation |
Datta Meghe Institute of Medical Sciences (Deemed University) Wardha |
| Address |
Department of Shalya Tantra,
Mahatma Gandhi Ayurved College,
Hospital and Research Center,
Salod, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9766811974 |
| Fax |
|
| Email |
sheetalasutkar16@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SHEETAL ASUTKAR |
| Designation |
PROFESSOR |
| Affiliation |
Datta Meghe Institute of Medical Sciences (Deemed University) Wardha |
| Address |
Department of Shalya Tantra,
Mahatma Gandhi Ayurved College,
Hospital and Research Center,
Salod, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9766811974 |
| Fax |
|
| Email |
sheetalasutkar16@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma gandhi ayurved college hospital and research center Wardha Maharashtra |
|
|
Primary Sponsor
|
| Name |
Mahatma gandhi ayurved college hospital and research center |
| Address |
Mahatma gandhi ayurved college hospital and research center |
| 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 PRADEEP KUMAR PRADHAN |
Mahatma gandhi ayurved college hospital and research center |
Department of Shalya Tantra,
Room no. 05
Wardha
MAHARASHTRA |
9907930733
drpradhanpradeep25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma gandhi ayurved college hospital and research center institutional ethics committee salod wardha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K929||Disease of digestive system, unspecified. Ayurveda Condition: PARIKARTIKA, (2) ICD-10 Condition:K929||Disease of digestive system, unspecified. Ayurveda Condition: PARIKARTIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Karanjadi Ghruta, Reference: 16. Shastri AD, editor. Varanasi: Chaukhambha Sanskrit Sansthan; 2019. Sushruta Samhita of AcharyaSushruta, Chikitsa Sthana. Reprint edition. Ch. 16, Ver. 16-21; , Route: Topical, Dosage Form: Ghrita, Dose: 3(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Yasthimadhu Ghruta , Reference: Mishra S N, Bhaishajya Ratnavali Varanasi: Chaukhambha Surbharti Prakashan; 2012, Reprint edition. Ch. 48, Ver. 1., Route: Topical, Dosage Form: Ghrita, Dose: 3(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: - | | 3 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Jatyadi Ghruta , Reference: 18. The Ayurvediv Pharmacopoeia of India, Volume 1, Part 2, New Delhi: Government of India,Ministry of Health and family Welfare, Deptt. Of AYUSH, New Delhi;2007.P.73 , Route: Topical, Dosage Form: Ghrita, Dose: 3(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Parikartika (Acute Fissure in Ano) patients who clinically diagnosed / confirmed by inspection.
2. Patients’ age- between 18 and 60 years in either sex.
3. Fissure-in-Ano patients of with controlled systemic diseases like Diabetes; and Hypertension
4. Willing full to participate and able to complete the study period.
|
|
| ExclusionCriteria |
| Details |
1. Parikartika (Fissure in Ano) present with secondary condition as Ulcerative colitis, Chron’s disease, Syphilis and Tuberculosis.
2. Patients with systemic disease like Diabete and Hypertension which is uncontrolled.
3. Patients with HIV and HbsAg positive.
4. Any condition which may jeopardize the study.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess efficacy of Karanjadi Ghruta Pichu in the Management of Parikartika in total effect of healing, pain, spasm & bleeding after 3 weeks of treatment |
To assess efficacy of Karanjadi Ghruta Pichu in the Management of Parikartika in total effect of healing, pain, spasm & bleeding after 3 weeks of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess efficacy of Karanjadi Ghruta Pichu in the Management of Parikartika in total effect of healing, pain, spasm & bleeding |
before treatment |
|
|
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)
|
16/02/2023 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NON YET |
|
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 participants will be randomly selected as per comport 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 are divided into three groups. The trial is a parallel-group, randomized, single-blind, standard - controlled trial. It will include, a 21 days treatment period, and a 7th, 14th & 21th day week follow-up period. |