| CTRI Number |
CTRI/2024/07/070264 [Registered on: 09/07/2024] Trial Registered Prospectively |
| Last Modified On: |
08/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical study on effect of ksheera basti (Medicated enema) in fissure |
|
Scientific Title of Study
|
A randomized controlled clinical study to evaluate the efficacy of yashtimadhu tila kalka ksheera basti in parikartika vis-Ã -vis 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 A R Sumanth Acharya |
| Designation |
PG Scholar |
| Affiliation |
Muniyal Institute of Ayurveda Medical Sciences, Manipal |
| Address |
OPD of Shalya tantra Room No-9, 1st floor,Muniyal Institute of Ayurveda Medical Sciences, Shivalli industrial area, Manipal, Udupi, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
7899613010 |
| Fax |
|
| Email |
sumanthar97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gururaja D |
| Designation |
Professor and HOD |
| Affiliation |
Muniyal Institute of Ayurveda Medical Sciences, Manipal |
| Address |
OPD of Shalya tantra Room No-9, 1st floor,Muniyal Institute of Ayurveda Medical Sciences, Shivalli industrial area, Manipal, Udupi, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
8762822790 |
| Fax |
|
| Email |
gurushalya@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr A R Sumanth Acharya |
| Designation |
PG Scholar |
| Affiliation |
Muniyal Institute of Ayurveda Medical Sciences, Manipal |
| Address |
OPD of Shalya tantra Room No-9, 1st floor,Muniyal Institute of Ayurveda Medical Sciences, Shivalli industrial area, Manipal, Udupi, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
7899613010 |
| Fax |
|
| Email |
sumanthar97@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Muniyal institute of ayurveda medical sciences |
| Address |
Muniyal institute of ayurveda medical sciences, Shivalli industrial area, , Manipal, Udupi, Karnataka 576104 |
| 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 A R Sumanth Acharya |
Muniyal institute of ayurveda medical sciences |
Out patient department of Shalya tantra, Room No-9 1st floor, Muniyal Institute of Ayurveda Medical Sciences, Shivalli industrial area, Manipal, Udupi, Karnataka, 576104
Udupi
KARNATAKA |
7899613010
sumanthar97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Muniyal institute of ayurveda manipal institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
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|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K602||Anal fissure, unspecified. Ayurveda Condition: PARIKARTIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | bastikarma/vastikarma, बसà¥à¤¤à¤¿à¤•à¤°à¥à¤®/वसà¥à¤¤à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Caraka samhita, Procedure details: Subject’s meeting inclusion criteria will be instructed to come preferably at morning hours to Shalya OPD.
Procedure will be explained to the subject & written consent will be obtained.
Detailed case history will be documented.
Patient will be taken to panchakarma theatre.
Stanika nadisweda will be done
The subjects are made to lie down in left lateral position.
The anal canal will be lubricated with xylocaine gelly.
Catheter is connected to syringe and introduced into anal canal
After completion of basti patient will be asked lie on supine position for few minutes
)
(1) Medicine Name: yashtimadhu grita, Reference: caraka samhita, Route: Rectal, Dosage Form: Ghrita, Dose: 30(ml), Frequency: od, Duration: 7 Days | | 2 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बसà¥à¤¤à¤¿à¤•à¤°à¥à¤®/वसà¥à¤¤à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Susshruta samhita Siddi sthana, Procedure details: (Procedure Reference: Caraka samhita, Siddisthana, Procedure details: Subject’s meeting inclusion criteria will be instructed to come preferably at morning hours to Shalya OPD. Procedure will be explained to the subject & written consent will be obtained. Detailed case history will be documented. Patient will be taken to panchakarma theatre. Stanika nadisweda will be done The subjects are made to lie down in left lateral position. The anal canal will be lubricated with xylocaine gelly. Catheter is connected to basti can & yashtimadhu tila kalka ksheera basti isintroduced into anal canal ,basti can is emptied. After completion of basti patient will be asked lie on supine position until he feels the urge to pass out basti Dravya. it is done once a day for 7days ))
(1) Medicine Name: Yashtimadhu tila kalka ksheera, Reference: Susshruta samhita Siddi sthana, Route: Rectal, Dosage Form: Ksheerpaka, Dose: 450(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Clinically diagnosed case of fissure in ano are taken for the study.
2.Patient of both sexes with age group of 18 to 60years.
3.Patients irrespective of religion, Occupation and economic status.
4.Acute fissure in ano and chronic fissure with acute onset.
|
|
| ExclusionCriteria |
| Details |
1.Patients having Fissure-in-ano secondary to Ulcerative colitis, Crohn’s disease, tuberculosis and malignancy of rectum and anal canal.
2.Patients with infectious diseases like HIV& HBsAg.
3.Patients with fissure associated with Hemorrhoids and Fistula-in- ano.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To relieve pain |
4th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To cure pain, bleeding, constipation |
7days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
25/07/2024 |
| 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="4"
Days="20" |
|
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 the commonest among anorectal disorders. Anal fissure is longitudinal split in anoderm of the distal anal canal which extends from anal verge proximally towards, but not beyond dentate line. Similarly, Parikartika is explained in ayurveda as excruciating cutting pain in the anal region. Every individual suffers from proctological symptoms at least once in their lifetime. Yashtimadhu ghrita Matra Basti is a Shamana Basti and it helps in wound healing. Yashtimadhu Tila Kalka Ksheera Basti on the other hand not only helps in wound healing but also acts as Shodhana Basti due to its Matra, thus preventing or treating Pureeshavaha Sroto Vikaras thereby regulating sphincter tone and preventing constipation. Yahtimadhu Tila Kalka Ksheera Basti is mentioned in Basti Vyapath. This is a clinical study between study group and control group. Minimum 40 clinically diagnosed patients of Parikartika (fissure in ano) are selected based on inclusion and exclusion criteria. The parameters of signs, symptoms and investigation will be scored on the basis of standard method and will be analyzed statistically. Registered patients will be allotted randomly into two equal groups of minimum 20 patients each A and B. Twenty subjects of this group will be subjected to Yashtimadhu Tila Kalka Ksheera Basti ;Dose: 450ml once a day ;Duration: 7 days. Twenty subjects of this group will be subjected to Yashtimadhu Ghrita Matra Basti: Dose: 30ml once a day;Duration: 7days.
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