| CTRI Number |
CTRI/2024/09/073793 [Registered on: 11/09/2024] Trial Registered Prospectively |
| Last Modified On: |
16/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Ayurveda management protocol for anal fissure |
|
Scientific Title of Study
|
Efficacy of an ayurvedic management protocol on the rate of recurrence, healing, and safety in Parikarthika (Fissure in Ano) -A Randomized 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 Indu P P |
| Designation |
Research Officer (Ay.) |
| Affiliation |
National ayurveda research institute for panchakarma Cheruthuruthy |
| Address |
Department Technical Ayurveda
Hospital section
Room No A612
NARIP Cheruthuruthy
CCRAS GoI
Harivihar Near Telephone exchange Perambra Kozhikkode Kerala
Thrissur
KERALA
679531
India |
| Phone |
9495312570 |
| Fax |
|
| Email |
dr.indupp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Indu P P |
| Designation |
Research Officer (Ay.) |
| Affiliation |
National ayurveda research institute for panchakarma Cheruthuruthy |
| Address |
Department Technical Ayurveda
Hospital section
Room No A612
NARIP Cheruthuruthy
CCRAS GoI
Harivihar Near Telephone exchange Perambra Kozhikkode Kerala
KERALA
679531
India |
| Phone |
9495312570 |
| Fax |
|
| Email |
dr.indupp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Indu P P |
| Designation |
Research Officer (Ay.) |
| Affiliation |
National ayurveda research institute for panchakarma Cheruthuruthy |
| Address |
Department Technical Ayurveda
Section hospital
Roon No A612
NARIP Cheruthuruthy
CCRAS GoI
Harivihar Near Telephone exchange Perambra Kozhikkode Kerala
KERALA
679531
India |
| Phone |
9495312570 |
| Fax |
|
| Email |
dr.indupp@gmail.com |
|
|
Source of Monetary or Material Support
|
| CCRAS Ministry of Ayush GOI New Delhi INDIA 110058 |
|
|
Primary Sponsor
|
| Name |
CCRAS |
| Address |
CCRAS head quarters Janakpuri New delhi India 110058 |
| Type of Sponsor |
Research institution |
|
|
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 Indu P P |
National Ayurveda Research Institute for Panchakarma Cheruthuruthy |
Room No A612 6th floor Hospital division
Technical ayurveda department, Hospital divion CHERUTHURUTHY
THRISSUR
Thrissur
KERALA |
9495312570
dr.indupp@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| National ayurveda research institute for panchakarma ethics committee |
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: Thriphala guggulu, Reference: AFI part 1 page 212, Route: Oral, Dosage Form: Guggulu , Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: -water), Additional Information: -(2) Medicine Name: avipathikara churna, Reference: AFI part 1 7:2, Route: Oral, Dosage Form: Churna/ Powder, Dose: 06(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: -water), Additional Information: -(3) Medicine Name: Thripahala churna, Reference: AFI part 1, Route: Topical, Dosage Form: Churna/ Powder, Dose: 20(g), Frequency: bd, Bhaishajya Kal: Muhurmuhu, Duration: 28 Days, anupAna/sahapAna: Yes(details: - ), Additional Information: -sitz bath with thriphala churna(4) Medicine Name: jathyadi taila, Reference: AFI part 1 , Route: Rectal, Dosage Form: Taila, Dose: 50(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 07 Days, anupAna/sahapAna: No, Additional Information: -infiltration with jathyadi taila for 7 adys and local application for 28 days | | 2 | Comparator Arm (Non Ayurveda) | | - | Diltiazem gel 2% application | Method of administration: Subjects will be instructed to apply the gel at least 1.5cm to 2cm into the anus
time of administration: morning and night after sitz bath
Duration of therapy: 4 weeks
Subject will be given Thriphala Kashaya sitz bath and thriphala churna 6 gm bd internally
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects of either sex with age between 18 and 60 years
Subjects diagnosed of parikarthika with pain, bleeding per rectum and constipation.
Subjects, willing to give written informed consent to participate in the study
|
|
| ExclusionCriteria |
| Details |
Subjects who are also suffering from, hemorrhoids, fistula in ano, peri anal abscess, fecal incontinence, and anal stenosis
Acute fissure in ano, Secondary fissures, fissures located at lateral location and multiple fissures
3. Subjects with co-morbidity such as Diabetes Meletus, uncontrolled Hypertension, inflammatory bowel disease, Sexually transmitted diseases, Hepatitis B and C, tuberculous ulcer, clinically significant renal disease, hepatic disease, cardiovascular disease and psychological diseases
Subjects on active drug abuse, alcoholics and on medication hampering wound healing.
Known sensitivity to any of the trial drugs or their ingredients
Subjects who are already underwent operative treatment and under non operative treatments like botulinum inj or calcium channel blockers or topical nitrates.
Subjects who are currently undergoing either of the trial intervention within 30 days of randomization of the study.
Pregnant/lactating woman.
Any other condition which the Investigator thinks may jeopardize the study.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
• Assessment of reduction in rate of recurrence of parikarthika i e the percentage of participant reported symptoms of fissure validated by physical examination, after the management with ayurveda protocol in comparison with diltiazem topical application.
|
8th week 12th week and 112th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Assessment of treatment efficacy of management protocol evaluated using the REALISE score, by degree of healing (Re epithelialization) scoring system and by spasm of anal sphincters in comparison with diltiazem topical application
• Assessment of the safety of the Ayurveda management protocol regimen through reported incidence of adverse events ((Time frame: 14th day,28th day,56th day,84th day,112thday) and also laboratory safety parameters from baseline (CBC, LFT, KFT)
• Assessment of comparative tolerability of the management protocol and diltiazem topical application through reported incidence of adverse events during the study period
• Change in health-related quality of life from baseline assessed through SF-12 questionnaire and patient satisfaction rated on a scale of 0 (failure) to 5 (excellent).
|
efficacy (Time frame: 14th day,28th day,56th day,84th day,112th day)
safety (Time frame: baseline, and 84th day)
tolerability (Time frame: 14th day and 28thday)
quality of life (Time frame: 14th day,28th day,56th day,84th day,112th day)
|
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 |
|
Date of First Enrollment (India)
|
01/10/2024 |
| 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="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
proctocol article under review |
|
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 one of the most common anorectal disease. Chance of recurrence of the condition is the most challenging issue in the management of the condition. The current study is a randomized controlled trial on the efficacy of an ayurvedic management protocol in parikarthika . The trial group management is by a standard conventional drug. sample size is 90 and the trial duration is 3 years . CCRAS is the sponsor and the study center is national ayurveda research institute for panchakarma. |