| CTRI Number |
CTRI/2020/08/027446 [Registered on: 28/08/2020] Trial Registered Prospectively |
| Last Modified On: |
27/08/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to study the safety and effect of the siddha medicine kattu karunai chooranam in patients having haemorrhoids (Mulai Moolam) |
|
Scientific Title of Study
|
Phase II Non randomised open clinical evaluation of siddha medicine kattu karunai chooranam for mulai moolam ( Haemorrhoids) |
| 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 Priya S |
| Designation |
PG scholar |
| Affiliation |
Government siddha medical college |
| Address |
PG scholar department of general medicine government siddha medical center arumbakkam Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9566207386 |
| Fax |
- |
| Email |
priya.131093@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chithra S M |
| Designation |
Assistant professor |
| Affiliation |
Government siddha medical college |
| Address |
Department of general medicine government siddha medical college arumbakkam chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9444177230 |
| Fax |
- |
| Email |
chittu758@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr priya s |
| Designation |
PG scholar |
| Affiliation |
Government siddha medical college |
| Address |
PG scholar department of general medicine government siddha medical college arumbakkam chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9566207386 |
| Fax |
- |
| Email |
priya.131093@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Siddha Medical College Arumbakkam Chennai 600106 |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College |
| Address |
Government Siddha Medical College Arumbakkam Chennai 600106 |
| Type of Sponsor |
Government 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 priya s |
Arignar anna government hospital of indian medicine |
Room no S1 siddha department nsk nagar arumbakkam chennai
Chennai
TAMIL NADU |
9566207386
-
priya.131093@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K640||First degree hemorrhoids, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Kattu Karunai Chooranam |
1 gram of Kattu Karunai Chooranam is administered twice a day with cows butter milk for 48 days |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients with appropriate symptoms like Bleeding during defecation
Constipation
Pain in anal region
Per rectal examination pile mass present |
|
| ExclusionCriteria |
| Details |
Pregnant and lactating mothers
Second degree haemorrhoids
External haemorrhoids
Fissure in ano
Fistula
Ca Rectum
Rectal Prolapse
Hb less than 8mg/dl |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Outcome is mainly assessed byreduction in clinical symptoms measured by reduction in pain, cessation of bleeding during defecation constipation |
48 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcome is comparing the safety parameters before and after treatment |
48 days |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
31/08/2020 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is Phase II Non randomised open clinical evaluation trial to study the safety and efficacy of siddha Medicine Kattu Karunai Chooranam for Mulai Moolam. The trial Drug is given 1 gram twice a day with cows butter milk for 48 days. Clinical trial conducted after condicting after preclinical toxicity study. The trial drug Kattu Karunai Chooranam mentioned in Agathiyar 2000 part 2. During the trial all the study related data will be recorded and documented. Ater complition of the trial all the data will be analysed statistically. |