| CTRI Number |
CTRI/2025/07/090797 [Registered on: 14/07/2025] Trial Registered Prospectively |
| Last Modified On: |
11/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To evaluate the effect of oral administration of Trivrut Triphala yog with Yashthimadhu ghrut local application in the management of Acute Fissure In Ano |
|
Scientific Title of Study
|
Evaluation of add on effect of oral administration of Trivrut Triphala yog along with Yashthimadhu ghrut local application in the management of Acute Fissure In Ano that is Parikartika Randomised controlled Trial |
| 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 Shital Ajit Lanke |
| Designation |
PG scholar |
| Affiliation |
R A Podar Ayurvedic College Annie Besant Road Madhukar Rajaram Dalvi Chowk Worli Mumbai 400018 |
| Address |
Department of Shalyatantra first floor R A Podar Ayurvedic College Annie Besant Road Madhukar Rajaram Dalvi Chowk Worli Mumbai 400018
Mumbai
MAHARASHTRA
400018
India |
| Phone |
9422316088 |
| Fax |
|
| Email |
omlanke@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shital Ajit Lanke |
| Designation |
PG scholar |
| Affiliation |
R A Podar Ayurvedic College Annie Besant Road Madhukar Rajaram Dalvi Chowk Worli Mumbai 400018 |
| Address |
Department of Shalyatantra first floor R A Podar Ayurvedic College Annie Besant Road Madhukar Rajaram Dalvi Chowk Worli Mumbai 400018
Mumbai
MAHARASHTRA
400018
India |
| Phone |
9422316088 |
| Fax |
|
| Email |
omlanke@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ramesh Jadhav |
| Designation |
HOD and associate professor |
| Affiliation |
R A Podar Ayurvedic College Annie Besant Road Madhukar Rajaram Dalvi Chowk Worli Mumbai 400018 |
| Address |
Department of Shalyatantra first floor R A Podar Ayurvedic College Annie Besant Road Madhukar Rajaram Dalvi Chowk Worli Mumbai 400018
Mumbai
MAHARASHTRA
400018
India |
| Phone |
9404857689 |
| Fax |
|
| Email |
ms.rameshjadhav82@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Shital Ajit Lanke |
| Address |
R A Podar Ayurvedic College Annie Besant Road Madhukar Rajaram Dalvi Chowk Worli Mumbai 400018 |
| 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 Shital Ajit Lanke |
R A Podar Ayurvedic College and M A Podar Hospital Worli Mumbai 400018 |
OPD no 10 Shalyatantra Vibhag R A Podar Ayurvedic College and M A Podar Hospital Annie Besant Road Madhukar Rajaram Dalvi Chowk Worli Mumbai 400018
Mumbai
MAHARASHTRA |
9422316088
omlanke@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| R A Podar Ayurvedic College IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K928||Other specified diseases of the digestive system. Ayurveda Condition: PARIKARTIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Trivrut Triphala yog , Reference: Charak chikitsasthan 14/6, Route: Oral, Dosage Form: Churna/ Powder, Dose: 4(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: Warm water ), Additional Information: Oral Trivrut Triphala yog is add on with Yashthimadhu ghrut local application for the study | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Yashthimadhu ghrut , Reference: Ashtang Hriday chikitsasthan 3/92, Route: Topical, Dosage Form: Ghrita, Dose: 1(ml), Frequency: bd, Bhaishajya Kal: Muhurmuhu, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: (2) Medicine Name: Yashthimadhu ghrut , Reference: Ashtang Hriday chikitsasthan 3/92, Route: Topical, Dosage Form: Ghrita, Dose: 1(ml), Frequency: bd, Bhaishajya Kal: Muhurmuhu, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Clinically diagnosed cases of Acute Fissure in Ano are taken for study
2 Patients irrespective of sex religion occupation and economic status
3 Patients ready to abide trial procedure and to give informed written consent |
|
| ExclusionCriteria |
| Details |
1 Patients having Fissure In Ano secondary to Ulcerative Colitis Syphilis Crohns disease Tuberculosis Malignancy of rectum and anal canal
2 Patients with Fissure In Ano with conditions like Haemorrhoids and Fistula In Ano
3 Patients having HTN DM TB HIV HBsAg any other immunosuppressant disorders
4 Pregnant lady |
|
|
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
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Size and area of ulcer |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 severity of pain
2 Duration of pain
3 Per rectal bleeding
4 Quality of life |
15 days |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
25/07/2025 |
| 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
|
Parikartika commonly known as fissure in ano is one of the most prevalent anorectal disorders often arising due to modern lifestyle factors like poor diet stress and irregular sleepThese lead to Agnimandya weak digestive fire which is considered the root cause of many diseases including Parikartika It is characterized by acute sharp pain during and after defecation followed by burning discomfort lasting 3 4 hours Pathologically it appears as an elongated ulcer along the anal canal primarily caused by chronic constipation and trauma from hard stools In Ayurveda Acharya Dalhan described Parikartika as pain resembling cutting and tearing Chhedanvat & Kartanvat pida in the anal region Ayurvedic Management Acharya Charak recommends TrivrutTriphala Yoga oral administration for ano-rectal disorders the best Sukhvirechan dravya mild purgative Triphala Amalaki Haritaki Bibhitaki has Deepan Pachan and Anuloman properties aiding digestion and bowel regulation Yashtimadhu Ghrita provides smooth muscle relaxation reducing pain during defecation and its Pittashamak and Vranaropak wound healing actions help relieve burning and promote healing Based on these therapeutic principles this study has been proposed |