| CTRI Number |
CTRI/2026/04/107453 [Registered on: 02/04/2026] Trial Registered Prospectively |
| Last Modified On: |
01/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
EVALUATION OF EFFECT OF NAGAVALLI VARTH
IN THE MANAGEMENT OF CHRONIC FISSURE-IN-ANO |
|
Scientific Title of Study
|
AN OPEN LABEL RANDOMIZED CLINICAL STUDY TO COMPARE THE
EFFICACY OF NAGAVALLI VARTH WITH DICLOFENAC SUPPOSITORY
IN THE MANAGEMENT OF CHRONIC 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 Nadhi Suresh |
| Designation |
PG SCHOLAR |
| Affiliation |
SRI SRI COLLEGE OF AYURVEDIC SCIENCE HOSPITAL AND RESEARCH |
| Address |
Department of PG Studies in Shalya Tantra, Sri Sri College of Ayurvedic, 21st KM, Kanakapura main road,
Udayapura Post, Bengaluru 560082 KARNATAKA India
Bangalore
KARNATAKA
560082
India |
| Phone |
09108254765 |
| Fax |
|
| Email |
nadhisuresh30@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr vivek j |
| Designation |
PROFESSOR |
| Affiliation |
SRI SRI COLLEGE OF AYURVEDIC SCIENCE HOSPITAL AND RESEARCH |
| Address |
Department of PG Studies in Shalya Tantra, Sri Sri College of Ayurvedic, 21st KM, Kanakapura main road,
Udayapura Post, Bengaluru 560082 KARNATAKA India
Bangalore
KARNATAKA
560082
India |
| Phone |
09108254765 |
| Fax |
|
| Email |
ayurvedabhishak@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nadhi Suresh |
| Designation |
PG SCHOLAR |
| Affiliation |
SRI SRI COLLEGE OF AYURVEDIC SCIENCE HOSPITAL AND RESEARCH |
| Address |
Department of PG Studies in Shalya Tantra, Sri Sri College of Ayurvedic, 21st KM, Kanakapura main road,
Udayapura Post, Bengaluru 560082 KARNATAKA India
Bangalore
KARNATAKA
560082
India |
| Phone |
09108254765 |
| Fax |
|
| Email |
nadhisuresh30@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Sri Ayurvedic hospital, 21st KM, Kanakapura main road
Udayapura Post, Bengaluru 560082 KARNATAKA India |
|
|
Primary Sponsor
|
| Name |
Dr Nadhi Suresh |
| Address |
DEPARTMENT OF PG STUDIES IN SHALYA TANTRA, SRI SRI COLLEGE OF
AYURVEDIC SCIENCE AND RESEARCH,21ST KM, KANAKAPURA ROAD BANGALORE KARNATAKA 560082 India |
| 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 Nadhi Suresh |
SRI SRI COLLAGE OF AYURVEDIC SCIENCE AND RESEARCH |
Department of PG Studies in Shalya Tantra, Sri Sri College of Ayurvedic, 21st KM, Kanakapura main road,
Udayapura Post, Bengaluru 560082 KARNATAKA India
Bangalore
KARNATAKA
560082
India
Bangalore
KARNATAKA |
9108254765
nadhisuresh30@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI SRI INSTITUTIONAL ETHICAL COMMITTEE |
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: Nagavalli varthi, Reference: Kamble SD, Yeola GH, Gaikwad PP, Waghmare AH. Tambula-Sevana as a healthy daily regimen: An Ayurveda overview. WJPR. 2021 Oct;10(12):497–507. doi:10.20959/wjpr202112-21715, Route: Rectal, Dosage Form: Varti/ Suppository, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Madhyabhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | diclofenac suppository | Diclofenac suppository 100 mg twice a day proved to be an excellent pain management method for fissure in ano cases in outpatient department care |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed case of chronic fissure-in-ano duration greater than six weeks
Parikarthika, sadaha, parikartana, anilasanga
Age group: 21 to 70 years, both genders willing to participate
Complaints of pain during defecation, bleeding per rectum, burning sensation, post-defecation
Single posterior anterior fissure on clinical examination.
Willing to give written informed consent.
Willing to comply with the treatment protocol and follow-up visits. |
|
| ExclusionCriteria |
| Details |
Acute fissure-in-ano duration less than 6 weeks.
Pregnant women
Known allergy or hypersensitivity to any components of diclofenac
Psychiatric illness or cognitive impairment
Patients suffering from systemic diseases like hepatitis, tuberculosis, HIV
Patient with associated anorectal disease like fistula in ano, hemorrhoids, polyp,
abscess and malignancy. |
|
|
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 |
Nagavalli Varthi will result in significant pain reduction and healing of chronic fissure-in-ano compared to Diclofenac suppository.
Severe pain to moderate pain
From moderate to mild pain
Significant healing of ulcer |
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in physical and psychological health
|
14th day |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
20/04/2026 |
| 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="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
|
THIS STUDY HAS BEEN TAKEN UP TO EVALUATE THE EFFICACY OF NAGAVALLI VARTHI WITH DICLOFENAC
SUPPOSITORY IN THE MANAGEMENT OF CHRONIC FISSURE-IN
ANOH0 - There is no significant difference between the efficacy of Nagavalli Varthi and
Diclofenac suppository in the management of Chronic fissure-in-ano. H1 - There is significant difference between the efficacy of Nagavalli Varthi and
Diclofenac suppository in the management of Chronic fissure-in-ano. |