| CTRI Number |
CTRI/2024/04/065511 [Registered on: 10/04/2024] Trial Registered Prospectively |
| Last Modified On: |
06/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Anal infiltration ] |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
To evaluate the effect of anal infiltration using Samamgadi Ropana Taila in comparison with Murivenna in Acute Fissure in ano |
|
Scientific Title of Study
|
An open label double arm comparative clinical study to assess the effect of anal
infiltration with Samamgadi Ropaṇa Taila and Murivenna in Acute 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 Aparna Thilak |
| Designation |
Second Year PG Scholar,Department of Shalya Tantra |
| Affiliation |
Amrita School Of Ayurveda,Amrita Vishwa Vidyapeetham |
| Address |
Department of Shalyatantra(surgery),OPD (OPD-3)Amrita School Of Ayurveda,Vallikkavu,Kollam,Kerala,India
Kollam
KERALA
690525
India |
| Phone |
9400488247 |
| Fax |
|
| Email |
aparnathilak95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shyam Vinayan |
| Designation |
Associate Professor |
| Affiliation |
Amrita School Of Ayurveda,Amrita Vishwa Vidyapeetham |
| Address |
Department of Shalyatantra(surgery),OPD(OPD-3)Amrita School Of Ayurveda,Vallikkavu,Kollam,Kerala,India
Kollam
KERALA
690525
India |
| Phone |
9447712392 |
| Fax |
|
| Email |
drshyamvinayan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aparna Thilak |
| Designation |
Second Year PG Scholar,Department of Shalya Tantra |
| Affiliation |
Amrita School Of Ayurveda,Amrita Vishwa Vidyapeetham |
| Address |
Department of Shalyatantra(surgery),OPD(OPD-3)Amrita School Of Ayurveda,Vallikkavu,Kollam,Kerala,India
Kollam
KERALA
690525
India |
| Phone |
9400488247 |
| Fax |
|
| Email |
aparnathilak95@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amrita School Of Ayurveda,Amrita Vishwavidyapeetham,Vallikkavu,Kollam,Kerala,India,690525 |
|
|
Primary Sponsor
|
| Name |
Dr Aparna Thilak |
| Address |
Second Year PG Scholar,Department Of Shalyatantra(surgery),Amrita School Of Ayurveda,Vallikkavu,Kollam,Kerala,India,690525 |
| Type of Sponsor |
Other [NIL] |
|
|
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 Aparna Thilak |
Amrita School Of Ayurveda |
Department of Shalya Tantra,Shalya tantra OPD(OPD-3),Room number-3,Amrita School Of Ayurveda,Amrita Vishwavidyapeetham,Vallikkavu,Kollam dist,Kerala,India,690525
Kollam
KERALA |
9400488247
aparnathilak95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Amrita School Of Ayurveda |
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 | Comparator Arm | Procedure | - | mAtrAbastiH, मातà¥à¤°à¤¾à¤¬à¤¸à¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Ashtanga Hridaya Sutrasthana 19th chapter, Procedure details: Patient will be advised to lie in left lateral position. Painting will be done with
betadine. The prepared 30 ml of Murivenna will be taken in a 30ml syringe & this syringe will be connected in to the Infant Feeding Tube No.10 and slowly inserted in to the anal canal and after lubricating the tube with the same taila. Infant Feeding Tube will be inserted up to 5cm.Then the syringe will be completely voided and the
anal verge will be packed with cotton pad.)
(1) Medicine Name: Murivenna, Reference: Ayurveda Pharmacopia Of India, Route: Rectal, Dosage Form: Taila, Dose: 30(ml), Frequency: od, Duration: 7 Days | | 2 | Intervention Arm | Procedure | - | mAtrAbastiH, मातà¥à¤°à¤¾à¤¬à¤¸à¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Ashtanga Hridaya Sutra sthana 19th chapter, Procedure details: Patient will be advised to lie in left lateral position. Painting will be done with
betadine. The prepared 30 ml of samaá¹gÄdi ropaṇa tailam will be taken in a 30ml syringe
and this syringe will be connected in to the Infant Feeding Tube No.10 & slowly inserted in
to the anal canal & after lubricating the tube with the same taila. Infant Feeding
Tube will be inserted up to 5cm.Then the syringe will be completely voided & the
anal verge will be packed with cotton pad. )
(1) Medicine Name: Samamgadi Ropana Taila, Reference: Susrutha chikitsa sadyovrana chikitsa, Route: Rectal, Dosage Form: Taila, Dose: 30(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient clinically diagnosed
with Acute Fissure-in-Ano.
2. Irrespective of gender and
socio-economic status.
3. Age between 20-40 |
|
| ExclusionCriteria |
| Details |
1.Chronic Fissure -in -Ano with Sentinal
Tag
2.Congenital diseases of anal canal.
3.Patient with systemic diseases like heart
diseases, DM, Carcinoma,
HIV, TB, IBS, Syphilis, Crohn’s
diseases.
4. Pregnancy |
|
|
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 |
Subjective Parameters
1)Pain
2)Constipation
3)Bleeding
Objective Parameters
1)Healing Of Wound
2)Sphincter Tone |
The assessments will be done on 0th day, 7th day, 14th
day, and 28th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Healing Of Wound
2)Sphincter Tone |
The assessments will be done after the follow up period |
|
|
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 3 |
|
Date of First Enrollment (India)
|
25/04/2024 |
| 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="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
|
Fissure-in-Ano is a longitudinal split in the anoderm of the distal anal canal, which extends from the anal verge proximally towards, but not beyond the dentate line. It can be acute or chronic.Fissure -in-Ano are considered to be acute if they have been present for less than 6 weeks.Acute type of fissure gets healed by conservative management.In acute conditions,Pain and constant internal sphincter spasm which results in delay in wound healing.Delay in wound healing will lead to the chronicity of the diseases leaving only surgical options.At times surgical treatments may restrict the quality of life of the patient and productive days. Specific medicine intending healthy granulation of the wound in Acute Fissure-in-Ano is taken into consideration.Simple formulations with easily available medicine and feasible method of local administration as an OPD Procedure which can give considerable result.Vrana ropana drugs which are easily available,easy to store and administer,cost effective and quick acting and that which yield good result will be ideal.In Samamgadi Ropana Taila phalasruti it is mentioned that "tailam ropanamuttamam".From the previous studies,Murivenna leads to re epithelialization of the wound.Wound healing,analgesics and anti-inflammatory activities of drugs has been taken into consideration.So the study is intended to assess the efficacy of anal infiltration of Samamgadi ropana Taila in comparison with Murivenna. Aim of the study is to test the efficacy of Anal infiltration of Samangadi Ropana Taila in comparison with Murivenna in conditions of wound Healing in Acute Fissure in Ano.With the help of the above properties of the drugs,Anal infiltration can be done by using Samamgadi Ropana Taila in one group of patients and Murivenna anal infiltration in other group of patients and the comparative effectiveness will be noted. In this study,30 patients irrespective of sex,with age limit of 20-40 years,satisfying the inclusion criteria will be recruited.The assessment will be done for duration and severity of pain,constipation,bleeding ,healing of wound and sphincter tone on 0th day,7th day,14th day,and 28th day.Wilcoxon signed rank test and Mann Whitney U Test will be used for statistical analysis |