| CTRI Number |
CTRI/2021/03/032371 [Registered on: 30/03/2021] Trial Registered Prospectively |
| Last Modified On: |
08/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Other |
|
Public Title of Study
|
A clinical trial on Kaattu Vakai Pattai Chooranam in the management of Raththamoolam (Bleeding haemorrhoids) |
|
Scientific Title of Study
|
A prospective open labelled,Non-Randomized,Phase II,Clinical trial of "Kaattu Vakai Pattai Chooranam "in the management of "Raththamoolam"(Bleeding Haemorrhoids) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
N Saraswathi |
| Designation |
Pg scholar |
| Affiliation |
Government siddha medical college and hospital,Palayamkottai,Tirunelveli |
| Address |
PG Department of pothu maruthuvam,OP no 10,
Government siddha medical college and hospital,Palayamkottai,Tirunelveli ,Tamilnadu
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
8190076987 |
| Fax |
|
| Email |
saraswathin30051967@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrGSubash chandran |
| Designation |
Lecturer Grade II |
| Affiliation |
Government siddha medical college and hospital |
| Address |
Department of PothuMaruthuvam,Op.no.10 Government Siddha medical college and hospital,Palayamkottai,Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443358271 |
| Fax |
|
| Email |
siddhadrgs21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrAManoharan |
| Designation |
Professor and HOD |
| Affiliation |
Government siddha medical college and hospital,Palayamkottai,Tirunelveli |
| Address |
Head of the Department, Department of PothuMaruthuvam,Op.no.10 Government siddha medical college and hospital,Palayamkottai,Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443886700 |
| Fax |
|
| Email |
drmanoharan25@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD &IPD facilities and Central library of Government Siddha Medical College and Hospital, Palayamkottai, Thirunelveli. |
|
|
Primary Sponsor
|
| Name |
Government siddha medical college and hospital |
| Address |
Government siddha medical college and hospital,Palayamkottai,Tirunelveli |
| 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 |
| N Saraswathi |
Government Siddha Medical College and Hospital |
PG Department of Pothu Maruthuvam ,OP no 10,
Government Siddha Medical College and Hospital,Palayamkottai,Tirunelveli
Tirunelveli
TAMIL NADU |
8190076987
saraswathin30051967@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL 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 |
Kaattu Vakai Pattai Chooranam |
2g/Twice a day(orally)A/F with ghee for 45 days |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients who will be having classical symptoms of bleeding piles (1st degree internal haemorrhoids)i.e. constipation, bleeding per anus,itching in the perianal region.
Patients who are all willing to give blood samples at subsequent visit are involved in this study.
Patient willing to sign the informed consent starting that he/ she will conscientiously stick to the treatment during 45 days but can opt of the trail of his/her own conscious discretion. |
|
| ExclusionCriteria |
| Details |
Patients of age below 18 years and above 60 years.
Patients having 2nd ,3rd degree internal haemorrhoids.
Pregnancy.
Fissure in ano.
External haemorrhoids.
Fistula in ano.
Diabetes mellitus.
Hypertension.
Rectal cancer. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Outcome of the treatment is mainly assessed by reduction in clinical symptoms and by comparing the following parameters before and after treatment.
Bleeding per rectum.
Proctoscopy. |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate Physico Chemical, PhytoChemical,Bio Chemical analysis.
To evaluate safety profile for acute and sub-acute toxicity of trial drug Kaattu Vakai Pattai Chooranam
To determine about Antimicrobial activities in different Solvents.
To evaluate additional effects &Siddha parameters, Envagaithervukal in Raththa Moolam
To evaluate the efficacy of Kaattu Vakai Pattai Chooranam on Raththamoolam by the Biostatistical analysis. |
45 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
02/04/2021 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study is a prospective open labelled non randomized phase II clinical study on KAATTU VAKAI PATTAI CHOORANAM in the management of RATHTHAMOOLAM (BLEEDING HAEMORRHOIDS).The trial drug will be administered at the dose of 2g/Twice a day orally A/F for 45 days along with ghee as adjuvent in 45 patients. The trial period of 12 months will be carrying out in Government siddha medical college and hospital,Palayamkottai,Tirunelveli. The primary outcome will be evaluation of therapeutic efficacy of trial drug KAATTU VAKAI PATTAI CHOORANAM. The secondary outcome will be the evaluation of siddha diagnostic parameters, assessment of safety profile of trial drug ,assessment of pharmacological and biochemical parameters of trial drug.In case of any adverse event (AE)is noticed and it will be referred to pharmacovigilance department of SCRI.Further management of patient will be given in OPD facility. |