| CTRI Number |
CTRI/2020/09/027883 [Registered on: 18/09/2020] Trial Registered Prospectively |
| Last Modified On: |
29/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Treatment of Ano-Rectal diseases (especially Fissure-in-Ano) with an Ayurvedic Gel |
|
Scientific Title of Study
|
DEVELOPMENT AND EVALUATION OF AKARAKARABHA
(Spilanthes acmella Murr.) GEL FOR ANALGESIC ACTIVITY IN PARIKARTIKA W.S.R TO ACUTE FISSURE-IN-ANO-A RANDOMIZED CONTROLLED CLINICAL TRIAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mohd shafi mahfuz |
| Designation |
MS PG Scholar |
| Affiliation |
KLE Shri BMK Ayurved Mahavidyalaya Belagavi |
| Address |
KLE Shri B M Kankanawadi Ayurved Mahavidyalaya and KLE Ayurveda Hospital and Medical Research centre Shahapur Belagavi Karnataka
Belgaum
KARNATAKA
590003
India |
| Phone |
8008452122 |
| Fax |
|
| Email |
shafimahfuz@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Laxmikant |
| Designation |
Professor |
| Affiliation |
KLE Shri BMK Ayurved Mahavidyalaya Belagavi |
| Address |
c/o Shalya Tantra Dept.
KLE Shri B M Kankanawadi Ayurved Mahavidyalaya and KLE Ayurveda Hospital and Medical Research centre Shahapur Belagavi Karnataka
Belgaum
KARNATAKA
590003
India |
| Phone |
9480007651 |
| Fax |
|
| Email |
shalyalsd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mohd shafi mahfuz |
| Designation |
MS PG Scholar |
| Affiliation |
KLE Shri BMK Ayurved Mahavidyalaya Belagavi |
| Address |
KLE Shri B M Kankanawadi Ayurved Mahavidyalaya and KLE Ayurveda Hospital and Medical Research centre Shahapur Belagavi Karnataka
Belgaum
KARNATAKA
590003
India |
| Phone |
8008452122 |
| Fax |
|
| Email |
shafimahfuz@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Ayurveda Pharmacy and Hospital and Medical Research centre shahapur Belagavi Karnataka 590003 |
|
|
Primary Sponsor
|
| Name |
KLE UNIVERSITY |
| Address |
Shri B M Kankanawadi Ayurved Mahavidyalaya and KLE Ayurveda Hospital and Medical Research Centre Shahapur Belagavi Karnataka 590003 |
| 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 |
| Mohd shafi mahfuz |
KLE Ayurveda Hospital and Medical Research Centre |
Shahapur Belagavi Karnataka 590003
Belgaum
KARNATAKA |
8008452122
shafimahfuz@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: K928||Other specified diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
2% Lignocaine gel |
Dose quantity sufficient
Frequency once in a day
Duration one day
Route of administration local application |
| Intervention |
AKARAKARABHA
(Spilanthes acmella Murr.) GEL |
Dose quantity sufficient
Frequency once in a day
Route of administration local application
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient with Parikartika (Acute Fissure-in-ano) |
|
| ExclusionCriteria |
| Details |
Patient with the history of HIV I and II HbsAg uncontrolled DM and HTN Pregnancy
Chrons disease Ulcerative colitis Carcinoma of rectum and other systematic diseases
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain, Burning sensation and Bleeding |
15 mins, 3rd hr, 6th hr, 12th hr, 24th hr |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain, Burning sensation and Bleeding |
2nd day |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
04/12/2020 |
| Date of Study Completion (India) |
26/12/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
26/12/2021 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To evaluate Analgesic activity of developed Akarakarabha (Spilanthes acmella Murr) gel in the management of Parikartika with special reference to Acute Fissure in ano
Developed Akarakarabha
(Spilanthes acmella Murr) gel is
having better analgesic effect in comparison to 2% Lignocaine gel in Parikartika with special reference to Acute
Fissure in ano
|