| CTRI Number |
CTRI/2025/06/088849 [Registered on: 13/06/2025] Trial Registered Prospectively |
| Last Modified On: |
13/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use of Tiktadi Ghrita on Acute fissure in ano |
|
Scientific Title of Study
|
Randomized controlled clinical trial to evaluate the efficacy of Tiktadi Ghrita in the management of Parikartika(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 Sonal Vijay Rathod |
| Designation |
MS Scholar Shalyatantra Department |
| Affiliation |
CSMSS Ayurved Mahavidyala and Rugnalaya Kanchanwadi Aurangabad |
| Address |
OPD No 16 of Shalyatantra Department CSMSS Ayurved Mahavidyalaya And Rugnalaya Kanchanwadi Aurangabad
CSMSS Ayurved Mahavidyala and Rugnalaya Kanchanwadi Aurangabad
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9422684723 |
| Fax |
|
| Email |
sonalr210@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Rajesh Nivruttirao Gundre |
| Designation |
Professor |
| Affiliation |
CSMSS Ayurved Mahavidyalaya And Rugnalaya Kanchanwadi Aurangabad |
| Address |
OPD No 16 of Shalyatantra Department CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India
CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9518548733 |
| Fax |
|
| Email |
rgundre200@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonal Vijay Rathod |
| Designation |
MS Scholar Shalyatantra Department |
| Affiliation |
CSMSS Ayurved Mahavidyala and Rugnalaya Kanchanwadi Aurangabad |
| Address |
OPD No 16 of Shalyatantra Department CSMSS Ayurved Mahavidyalaya And Rugnalaya Kanchanwadi Aurangabad
CSMSS Ayurved Mahavidyala and Rugnalaya Kanchanwadi Aurangabad
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9422684723 |
| Fax |
|
| Email |
sonalr210@gmail.com |
|
|
Source of Monetary or Material Support
|
| CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431001 |
|
|
Primary Sponsor
|
| Name |
CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad |
| Address |
Department of Shalyatantra CSMSS Ayurved Mahavidyalaya And Rugnalaya Kanchanwadi Maharashtra India 431001 |
| Type of Sponsor |
Private 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 |
| Dr Sonal Vijay Rathod |
CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi |
OPD No 16 of Shalyatantra Department CSMSS Ayurved Mahavidyalaya And Rugnalaya Kanchanwadi Aurangabad
Aurangabad
MAHARASHTRA |
9422684723
sonalr210@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CSMSS Ayurved Mahavidyalay and Rugnalaya Kanchanwadi Aurangabad |
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, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Tiktadi Ghrita, Reference: Bhaishajya Ratnavali Adhaya 47 Shlok 63, Route: Topical, Dosage Form: Ghrita, Dose: 2(ml), Frequency: bd, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 2 Weeks, Reference: No, Route: -, Dosage Form: Ghrita, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shatadhaut Ghrita, Reference: Brihatnighantu Ratnakar Adhayay 1325, Route: Topical, Dosage Form: Ghrita, Dose: 2(ml), Frequency: bd, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 2 Weeks, Reference: No, Route: -, Dosage Form: Ghrita, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Clinicaly diagnosed cases of acute fissure in ano will be takenfor study.
Selection will be irrespective of sex, religion, and socioeconomic status.
Age between 16-70 years. |
|
| ExclusionCriteria |
| Details |
Clinically diagnosed patient with chronic fisssure in ano will be excluded.
Patients having fissure in ano secondary to Ulcerative colitis, Chrons diseases, Syphilis and Tuberculosis will be excluded.
Patients with uncontrolled systemic diseases like Diabetes and Hypertension will be excluded. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To reduce signs and symptoms of Parikartika (Acute fissure in ano) i.e Burning pain, Bleeding, Sphincter tone Constipation, Size of ulcer till 14 days |
To reduce signs and symptoms of Parikartika (Acute fissure in ano) i.e Burning pain, Bleeding, Sphincter tone Constipation, Size of ulcer till 14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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)
|
25/06/2025 |
| 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)
|
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
|
A fissure in ano, known as Parikartika in ayurved. It is a longitudinal tear in the lower end of the anal canal. It is the most painful condition affecting the anal canal region. The prevalence rate of fissure in ano is 18 percent . The number of patients with fissures in ano is found to be increasing due tofast food and a sedentary lifestyle. If the acute fissure in ano fails to heal, it will develop into chronic fissure in ano.To avoid this complication this study is taken. To assess vranaropan karma of Tiktadi ghrita in the management of parikartika. To provide cost effective treatment.
The study will be conducted on 92 diagnosed patients of parikartika ( acute fissue in ano). Written consent will be taken. Initial assessment on 1st day and randomization will be done. The patient will be divided into 2 groups Trial group A Tiktadi ghrita Control group B Shatadhaut ghrita Observation and result will be noted Discussion and conclusion Summary |