| CTRI Number |
CTRI/2024/07/070027 [Registered on: 04/07/2024] Trial Registered Prospectively |
| Last Modified On: |
03/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A CLINICAL STUDY TO EVALUATE THE EFFICACY OF AYU-ANO-D-GEL
(LOCALLY) ALONG WITH HARITAKI CHURNA VATI (ORALLY) IN THE
MANAGEMENT OF PARIKARTIKA W.S.R. TO FISSURE IN ANO. |
|
Scientific Title of Study
|
A CLINICAL STUDY TO EVALUATE THE EFFICACY OF AYU-ANO-D- GEL
(LOCALLY) ALONG WITH HARITAKI CHURNA VATI (ORALLY) IN THE
MANAGEMENT OF PARIKARTIKA W.S.R. TO 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 |
Damini Vilas Raut |
| Designation |
Pg scholar (Shalya) |
| Affiliation |
D. Y. Patil school of Ayurveda Nerul Navimumbai |
| Address |
D.Y Patil School of Ayurveda deemed to be university Nerul Navimumbai
Dr. D.Y. Patil School of Ayurveda deemed to be university Nerul Navimumbai 400706
Thane
MAHARASHTRA
400709
India |
| Phone |
9309859226 |
| Fax |
|
| Email |
daminiraut8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Vedika Bhoir |
| Designation |
Associate professor |
| Affiliation |
D. Y. Patil school of Ayurveda Nerul Navimumbai |
| Address |
D. Y. Patil school of Ayurveda deemed to be university Nerul Navimumbai sec. 6
D. Y. Patil school of Ayurveda deemed to be university Nerul Navimumbai sec 6
Thane
MAHARASHTRA
400706
India |
| Phone |
9029112333 |
| Fax |
|
| Email |
vedika.bhoir@dypatil.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Vedika Bhoir |
| Designation |
Associate professor |
| Affiliation |
D. Y. Patil school of Ayurveda deemed to be university Nerul Navimumbai |
| Address |
D. Y. Patil school of Ayurveda deemed to be university Nerul Navimumbai sec. 6
D. Y. Patil school of Ayurveda deemed to be university Nerul Navimumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9029112333 |
| Fax |
|
| Email |
vedika.bhoir@dypatil.edu |
|
|
Source of Monetary or Material Support
|
| D. Y. Patil school of Ayurveda Nerul Navimumbai |
|
|
Primary Sponsor
|
| Name |
Damini Raut |
| Address |
D. Y. Patil school of Ayurveda Nerul Navimumbai sec 6 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Vedika Bhoir |
Opd no 3 |
D y Patil School of Ayurveda Nerul Navimumbai sec 6
Thane
MAHARASHTRA |
9029112333
vedika.bhoir@dypatil.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee D. Y. Patil deemed to be university school of Ayurveda Nerul Navimumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K600||Acute anal fissure. Ayurveda Condition: PARIKARTIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Ayu-Ano-D-gel , Reference: Bhaishajya kalpana , Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 3(g), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: Application before and after defecation in morning and at bed time (2) Medicine Name: Haritaki church vati , Reference: Bhaishajya kalpana , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: hs, Bhaishajya Kal: Antarabhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: 4 tablet at bed time |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Clinically diagnosed Patients of Acute fissure in ano (Onset upto 28 days) without Sentinel Tag & Anal papillae.
Patients among the age group 18 to 60 yrs, irrespective of gender religion, occupation, educational status, and socio-economic status. |
|
| ExclusionCriteria |
| Details |
Chronic Fissure in Ano (Onset more than 28 days) with Sentinel Tag & Anal papillae.
Bleeding Disorder like Hemophilia etc.
Patient with uncontrolled systemic disease like diabetes and hypertension.
Patient with Ca rectum. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO STUDY THE CLINICAL EFFICACY OF AYU-ANO-D GEL(LOCALLY) ALONG WITH HARITAKI CHURNA VATI (ORALLY) IN THE MANAGEMENT OF PARIKARTIKA W.S.R. TO FISSURE IN ANO. |
TO STUDY THE CLINICAL EFFICACY OF AYU-ANO-D GEL(LOCALLY) ALONG WITH HARITAKI CHURNA VATI (ORALLY) IN THE MANAGEMENT OF PARIKARTIKA W.S.R. TO FISSURE IN ANO. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• To evaluate the effect of AYU-ANO-D GEL (Locally) in the management of symptoms of acute fissure in ano such as Burning sensation, Pain, Ulcer & Bleeding P/R.
• To establish AYU-ANO-D GEL as local (user friendly), cost effective treatment for Parikartika w.s.r. to fissure in ano.
• To review the Ayurvedic & Modern literature in context to Parikartika & Fissure in Ano & advancement in its management.
• To validate the ancient mode of treatment in this scientific era.
|
PR bleeding in 3 days
Vedanasthapan in 1 day
Shoth in 2 days
Vranropan in 7 days |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
15/07/2024 |
| 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="1"
Months="0"
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
|
Background: Fissure in ano is a very common and painful condition of the anal canal. It is a most common proctologic condition that affects the world wide population and cause of trouble in day to day life. Fissure in ano can be defines as longitudinal tear in the superficial skin (squamous epithelial lining) of the anal canal. The fissure in ano is most commonly found posteriorly in the midline of anal canal, as it is the least protected part of the anal canal. In Ayurveda fissure in ano can be correlated with Parikartika. The word Parikartika is a combination of two words. Pari (around the anus) and kartika (Cutting Pain). It is a condition characterized by Kartanvat pida in gudabhaga (Cutting like pain around the anus). In parikartika, there is longitudinal cut. According to Sushruta Gudavran is a sadyovran (easily curable disease) (Su. Chi. 36/6). Kashyap mentioned management of parikartika according to doshik involvement of parikartika (Ka. S. Chi. 2/1). None of the samhita describes about surgical management, so it indicates that conservative management is sufficient for the treatment of Parikartika. Material & Methods: AYU-ANO-D GEL will be a 100% natural and Ayurvedic preparation which includes drugs such as Dhataki pushpa arka and Menthol including xantham gum as natural polymer. Results: AYU-ANO-D GEL (Locally) will show effective results in Parikartika such as Vedanaharan, Raktasthamban, Vranropan & Shothaharan properties. Keywords: Acute fissure in ano, Ayurveda, AYU-ANO-D Gel, parikartika, Sadhyovrana, Vranropana, etc. |