| CTRI Number |
CTRI/2026/02/102833 [Registered on: 03/02/2026] Trial Registered Prospectively |
| Last Modified On: |
02/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
An Ayurvedic Study on Jyotismati Gel for the Treatment of Anal Fissure |
|
Scientific Title of Study
|
A RANDOMIZED CONTROLLED CLINICAL TRIAL ON APPLICATION OF
JYOTISMATI GEL 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 |
Ganesh V |
| Designation |
PG Scholar |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda College and Hospital |
| Address |
Sri Jayendra Saraswathi Ayurveda College and Hospital Nazarathpet Chennai
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
7358259830 |
| Fax |
|
| Email |
drganesh1130@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr T Udaya Kiran |
| Designation |
Professor and HOD |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda College and Hospital |
| Address |
Sri Jayendra Saraswathi Ayurveda College and Hospital Nazarathpet Chennai
Sri Jayendra Saraswathi Ayurveda College and Hospital Nazarathpet Chennai
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
9849666054 |
| Fax |
|
| Email |
dr_tenneti@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Ganesh V |
| Designation |
PG Scholar |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda College and Hospital |
| Address |
Sri Jayendra Saraswathi Ayurveda College and Hospital Nazarathpet Chennai
Sri Jayendra Saraswathi Ayurveda College and Hospital Nazarathpet Chennai
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
735859830 |
| Fax |
|
| Email |
drganesh1130@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Jayendra Saraswathi Ayurveda College and Hospital |
|
|
Primary Sponsor
|
| Name |
Dr Ganesh V |
| Address |
Sri Jayendra Saraswathi Ayurveda College and Hospital, Nazarathpet, Chennai - 600123 |
| 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 Ganesh V |
Sri Jayendra Saraswathi Ayurveda College and Hospital |
Sri Jayendra Saraswathi Ayurveda College and Hospital Nazarathpet Chennai
Thiruvallur
TAMIL NADU |
735859830
drganesh1130@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, Sri Jayendra Saraswathi Ayurveda College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K601||Chronic anal fissure. Ayurveda Condition: PARIKARTIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Jatyadi Ghritam, Reference: Charaka Samhita, Chikitsa Sthana, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 5(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Jyotismati Gel, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 5(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Subject diagnosed with Fissure-in-Ano as per the above diagnostic
criteria.
2. Subject between the age group of 18-60 years. |
|
| ExclusionCriteria |
| Details |
1. Subjects diagnosed with cases of Crohn’s disease, Diverticulitis, and Ulcerative colitis
2. Severe anal stenosis
3. Congenital anomalies of rectum and anal canal
4. Subjects diagnosed with malignancy
5. Known case of HIV, Syphilis, TB.
6. Localized infection.
7. Pregnant Women |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To access the effect of jyothismathi gel in the management of pain in Parikartika |
14 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
16/02/2026 |
| 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 Yet Recruiting |
| 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
|
Fissure in Ano is a common anorectal condition presenting with pain and burning sensation and can be correlated with Parikartika described in Ayurveda. The prevalence of anal fissure is high in India, especially in Tamil Nadu, largely due to unhealthy dietary habits. Conventional management includes conservative and surgical methods; however, surgical procedures may be associated with complications, emphasizing the need for a safe, cost-effective, and patient-friendly treatment. Parikartika is a Vatapitta-dominant condition localized to the Guda and is characterized by pain, burning sensation, bleeding, and constipation. Ayurvedic conservative management has shown good efficacy in such conditions. Jyotismati (Celastrus paniculata) possesses analgesic, anti-inflammatory, wound-healing, and antibacterial properties, while jatyadi ghrutam is a classical formulation indicated in wound management and anorectal disorders.
This randomized controlled clinical study aims to evaluate and compare the efficacy of jyotismati gel and jatyadi ghrutam in the management of Parikartika (Fissure in Ano). Dietary modifications and lifestyle advice will be provided to all participants. The study will assess improvement in pain, burning sensation, bleeding, fissure healing, and overall patient com |