| CTRI Number |
CTRI/2023/01/048749 [Registered on: 04/01/2023] Trial Registered Prospectively |
| Last Modified On: |
03/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [pichu dharana] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
management of anal tear by ayurveda |
|
Scientific Title of Study
|
A Randomized Comparative Clinical Study To Evaluate The Efficacy Of Nimbapatra Taila Pichu Over Yashtimadhu Taila Pichu In The Management Of Parikartika With Special Reference To Acute 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 Ayesha Kaladgi |
| Designation |
BAMS PG Scholar |
| Affiliation |
BLDEAs AVS AYURVEDA MAHAVIDYALAYA VIJAYAPURA |
| Address |
Dr Ayesha Kaladgi PG Scholar, Deparetment of Shalyatantra,BLDEAs AVS Ayurveda Mahavidyalaya,Hospital and Research Centre,Vijayapura-586109
Bijapur
KARNATAKA
586109
India |
| Phone |
8050007385 |
| Fax |
|
| Email |
aishafayazkaladgi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prasadshakti GGannur |
| Designation |
Professor and HOD |
| Affiliation |
BLDEAs AVS AYURVEDA MAHAVIDYALAYA VIJAYAPURA |
| Address |
Dr Prasadshakti G.Gannur
Professor and HOD Dept.of PG Studies in Shalyatantra
BLDEAs AVS Ayurveda Mahavidyalaya,Hospital and Research Centre Vijayapur 586109
Bijapur
KARNATAKA
586109
India |
| Phone |
9480062140 |
| Fax |
|
| Email |
pgannur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prasadshakti GGannur |
| Designation |
Professor and HOD |
| Affiliation |
BLDEAs AVS AYURVEDA MAHAVIDYALAYA VIJAYAPURA |
| Address |
Dr Prasadshakti G.Gannur
Professor and HOD Dept.of PG Studies in Shalyatantra
BLDEAs AVS Ayurveda Mahavidyalaya,Hospital and Research Centre Vijayapur 586109
Bijapur
KARNATAKA
586109
India |
| Phone |
9480062140 |
| Fax |
|
| Email |
pgannur@gmail.com |
|
|
Source of Monetary or Material Support
|
| BLDEAs AVS Ayurveda Mahavidyalaya Vijayapura 586109 Karnataka |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
nil |
| 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 Ayesha Kaladgi |
BLDEAS AVS AYURVEDA MAHAVIDYALAYA VIJAYAPURA |
Shalyatantra 11 OPD BLDEAs AVS Ayurveda Mahavidyalaya Hospital and research Centre Vijayapura 586109
Bijapur
KARNATAKA |
8050007385
aishafayazkaladgi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL 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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: yashtimadhu taila, Reference: sushruta samhita, Route: Rectal, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 21 Days, Reference: No, Route: NA, Dosage Form: Taila, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: nimba patra taila, Reference: sushruta samhita, Route: Rectal, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 21 Days, Reference: No, Route: NA, Dosage Form: Taila, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients having classical features of acute fissure-in ano namely a longitudinal ulcer in the anal region with any one or more of the following features:
Excruciating pain in anal region during and after defecation, bleeding per anum, Constipation, Burning sensation and presence of Sphincter spasm will be selected.
2.Acute solitary fissure.
3.Patients of age group 17-70 years of both gender.
|
|
| ExclusionCriteria |
| Details |
1.Patients with K/C/O Ulcerative colitis, Syphilis, Crohn’s disease, inflammatory bowel disease and other systemic disease pertaining to rectum and anal canal will be excluded from the study.
2.Acute multiple fissures will be excluded from the study.
3.Patient with chronic fissure in ano,ca of rectum,ca of anal canal, fistula in ano, hemorrhoids or any other ano-rectal diseases.
4.Patient with systemic disorders such as diabetes, tuberculosis.
5.HIV, HBsAg& HCV positive patients.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| relief in burning sensation,pain in parikartika within a week |
21 days from the day of enrollment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Healing of ulcer within 10 days |
21 days |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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 2 |
|
Date of First Enrollment (India)
|
12/06/2023 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is randomized comparative clinical study to evaluate the efficacy of Nimbapatra taila pichu over Yashtimadhu taila pichu in the management of parikartika with special reference to acute fissure in ano that will be conducted in BLDEAs AVS Ayurveda Mahavidyalaya,Hospital and Research Centre ,Vijayapura-586109 Karnataka ,India |