| CTRI Number |
CTRI/2021/05/033587 [Registered on: 12/05/2021] Trial Registered Prospectively |
| Last Modified On: |
18/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
THE EFFECT OF TRIPHALA GHRITA GUDA-PICHU WITH TRIPHALA KWATHA AVAGAHA SWEDA IN THE MANAGEMENT OF PARIKARTIKA w.s.r. TO FISSURE-IN-ANO†|
|
Scientific Title of Study
|
“A RANDOMIZED COMPARITIVE CLINICAL STUDY TO EVALUATE THE EFFECT OF TRIPHALA GHRITA GUDA-PICHU WITH TRIPHALA KWATHA AVAGAHA SWEDA IN THE MANAGEMENT OF PARIKARTIKA w.s.r. TO FISSURE-IN-ANO†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Beatrice Synnah |
| Designation |
PG scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara college of ayurveda kuthpady,udupi |
| Address |
Department of PG studies in shalyatantra Sri Dharmasthala manjunatheswara kuthpady udupi
Department of PG studies in shalyatantra Sri Dharmasthala manjunatheswara kuthpady udupi
Udupi
KARNATAKA
574118
India |
| Phone |
9101049716 |
| Fax |
|
| Email |
trixysynnah@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rakesh R N |
| Designation |
Associate Professor |
| Affiliation |
shri Dharamasthala Manjunatheshwara college of ayurveda kuthpady,udupi |
| Address |
Department of PG studies in shalyatantra Sri Dharmasthala manjunatheswara kuthpady udupi
Department of PG studies in shalyatantra Sri Dharmasthala manjunatheswara kuthpady udupi
Udupi
KARNATAKA
574118
India |
| Phone |
9449753320 |
| Fax |
|
| Email |
rakesharyan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Beatrice Synnah |
| Designation |
PG Scholar |
| Affiliation |
sri dharmasthala manjunatheswara college of ayurveda kuthpady,udupi |
| Address |
Department of PG studies in shalyatantra Sri Dharmasthala manjunatheswara kuthpady udupi
Department of PG studies in shalyatantra Sri Dharmasthala manjunatheswara kuthpady udupi
Udupi
KARNATAKA
574118
India |
| Phone |
9101049716 |
| Fax |
|
| Email |
trixysynnah@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala manjunatheswara kuthpady udupi |
|
|
Primary Sponsor
|
| Name |
Shri Dharamshala manjunatheshwara college of ayurveda kuthpadyudupi |
| Address |
Kuthpady,udupi |
| Type of Sponsor |
Private medical college |
|
|
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 Beatrice synnah |
Shri Dharamasthala Manjunatheshwara college of ayurveda kuthpady,udupi |
Department of PG studies in shalyatantra Sri Dharmasthala manjunatheswara kuthpady udupi
Udupi
KARNATAKA |
9101049716
trixysynnah@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL CLEARANCE COMMITTEE- HUMAN |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K602||Anal fissure, unspecified. Ayurveda Condition: PARIKARTIKA, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Guda pichu & Avagaha |
A gauze piece is dipped in the triphala ghrita and is to be placed in the anus gently for 15 minutes
Explaining and demonstrating the method of Guda – Pichu to the patient on the day of consultation is to be done. The patient will be asked to do the same procedure, once daily for 7 days after the bowel has been passed.
• The patient is made to sit in a tub which is filled with luke warm triphala kwatha . The level of the kwatha should be about 3 to 4 inches (7.6 to 10.2cm)
The temperature of the kwatha is maintained by replacing the cold kwatha with warm one frequently
This procedure is to be done for 15 minutes
The patient will be asked to do the same procedure, once daily, for 7 day after the bowel has been passed.
|
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with clinical signs and symptoms of Parikartika ( Fissure in Ano ) as explained in Ayurvedic Classics.
Subjects fulfilling diagnostic criteria who are willing to give their written informed consent and follow up the protocol of study will be selected.
|
|
| ExclusionCriteria |
| Details |
Patients suffering from systemic diseases like uncontrolled diabetes mellitus, tuberculosis , HIV, hepatitis.
Patients with associated anorectal diseases like complicated hemorrhoids , polyp, fistula in ano , crohn’s disease, ulcerative colitis and malignancy
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in pain,Burning sensation.
wound is healing & size reduced.No constipation will be there. |
1week 2weeks and 3weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement of sphincter tone. |
7 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/05/2021 |
| Date of Study Completion (India) |
18/07/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NO |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The current study will be “A RANDOMIZED COMPARITIVE CLINICAL STUDY TO EVALUATE THE EFFECT OF TRIPHALA GHRITA GUDA-PICHU WITH TRIPHALA KWATHA AVAGAHA SWEDA IN THE MANAGEMENT OF PARIKARTIKA w.s.r. TO FISSURE-IN-ANOâ€. in this study minimum of 40 diagnosed case of parikartika w.s.r. fissure in ano will be choosen. METHOD OF PLACING GUDA-PICHU A gauze piece is dipped in the triphala ghrita and is to be placed in the anus gently for 15 minutes.Explaining and demonstrating the method of Guda – Pichu to the patient on the day of consultation is to be done. The patient will be asked to do the same procedure, once daily for 7 days after the bowel has been passed. Method of Avagaha Sweda The patient is made to sit in a tub which is filled with luke warm triphala kwatha . The level of the kwatha should be about 3 to 4 inches (7.6 to 10.2cm).The temperature of the kwatha is maintained by replacing the cold kwatha with warm one frequently.This procedure is to be done for 15 minutes.The patient will be asked to do the same procedure, once daily, for 7 day after the bowel has been passed. |