| CTRI Number |
CTRI/2023/05/052275 [Registered on: 03/05/2023] Trial Registered Prospectively |
| Last Modified On: |
|
| 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 on Kuppaimeni Chooranam in the management of RATHTHA MOOLAM (BLEEDING HEMORRHOIDS) |
|
Scientific Title of Study
|
A PROSPECTIVE OPEN LABELLED, SINGLE ARM, NON- RANDOMIZED, SINGLE CENTRIC, PHASE II CLINICAL TRIAL TO DETERMINE THE EFFECTIVENESS OF KUPPAIMENI CHOORANAM IN THE MANAGEMENT OF RATHTHA MOOLAM (BLEEDING HEMORRHOIDS) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Berfin Flower P C |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
PG Department of Pothu Maruthuvam,OP no:10, Government
Siddha Medical College and Hospital, Palayamkottai.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
7358248370 |
| Fax |
|
| Email |
berfinflower@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P Sathish Kumar MDs |
| Designation |
Lecturer |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
PG Department of Pothu Maruthuvam,OP no:10, Government
Siddha Medical College and Hospital, Palayamkottai.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9944337757 |
| Fax |
|
| Email |
drpsk_md@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr A Manoharan MDsPhD |
| Designation |
Professor and HOD |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
PG Department of Pothu Maruthuvam OP no :10, Government
Siddha Medical College and Hospital, Palayamkottai.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443886700 |
| Fax |
|
| Email |
drmanoharan25@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD and IPD facilities and Central Library of Government Siddha Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College and Hospital |
| Address |
Government Siddha Medical College and Hospital, Palayamkottai,
Tirunelveli, Tamil Nadu,627002 |
| 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 Berfin Flower P C |
Government Siddha Medical College and Hospital |
Government Siddha Medical College and Hospital, Palayamkottai,
Tirunelveli,Tamilnadu
Tirunelveli
TAMIL NADU |
7358248370
berfinflower@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 |
KUPPAIMENI CHOORANAM |
1gm twice a day (orally) with
water for 45 days. |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients who will be having classical symptoms of bleeding piles (1st degree Internal Hemorrhoids) i.e. constipation, Bleeding per anus, Itching in the perianal region.
2.Patients who are all willing to give blood samples at subsequent visit are involved in this study.
|
|
| ExclusionCriteria |
| Details |
1.Patients of age below 18 years and above 60 years.
2.Patient having 2nd, 3rd degree internal haemorrhoids,Pregnancy,Fissure in ano,Fistula in ano,Diabetes mellitus,Systemic Hypertension.
Rectal Malignancy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Of during and after treatment and reduction in clinical symptoms of bleeding during defecation, constipation after defecation, pruritus ani. |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To evaluate the pharmacological activities of
trial drug.
2.Study about the prevalence of RATHA
MOOLAM in relation between diet and lifestyle.
3.To determine antimicrobial activity of trail drug
in different solvents.
4.To find out primary phytochemical analysis in
trail drug.
5.To evaluate proctoscopical changes in internal
haemorrhoids.
6.To evaluate safety profile for acute and
subacute toxicity.
7.To perform bio chemical analysis. |
45 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)
|
21/05/2023 |
| 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="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 phase II non-randomized clinical trial to evaluate the therapeutic efficacy of KUPPAIMENI CHOORANAM in the management of RATHA MOOLAM (BLEEDING HAEMORRHOIDS). The trial drug will be administered orally at the dose of 1gm twice a day A/F for 45 days along with water as adjuvant in 40 patients. The trial period of 12 months will be carried out in Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli, Tamil Nadu. The primary outcome will be the evaluation of therapeutic efficacy of trial drug KUPPAIMENI 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 events (AE)is noticed and it will be referred to pharmacovigilance department of SCRI. Further management of patients will be given in OPD facility. |