| CTRI Number |
CTRI/2025/02/080709 [Registered on: 17/02/2025] Trial Registered Prospectively |
| Last Modified On: |
11/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical trial on Lavangapattai Kudineer in the management of Raththa moolam(Bleeding Hemorrhoids) among patients attending OPD and IPD of Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli |
|
Scientific Title of Study
|
A Prospective,open labelled, Single arm, Non-randomized, Single centric, Phase II clinical trial to determine the effectiveness of Lavangapattai Kudineer in the management of Raththa Moolam( Bleeding Hemorrhoids) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
R SATHIYASEELAN |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College and Hospital palayamkottai |
| Address |
Op number 10,PG department of Pothu Maruthuvam, Government Siddha Medical College and Hospital, Tiruvananthapuram main road, Palayamkottai, Tirunelveli
Government Siddha Medical College and Hospital, Tiruvananthapuram main road, Palayamkottai, Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
8838637992 |
| Fax |
|
| Email |
sathiyastar4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P Sathish kumar |
| Designation |
Lecturer |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
PG department of Pothu Maruthuvam, Government Siddha Medical College and Hospital, Tiruvananthapuram main road, Palayamkottai, Tirunelveli
Government Siddha Medical College and Hospital, Tiruvananthapuram main road, Palayamkottai, Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9944337757 |
| Fax |
|
| Email |
drpsk_md@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr T Komalavalli Alias Mehala |
| Designation |
Head of the department |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
PG department of Pothu Maruthuvam, Government Siddha Medical College and Hospital, Tiruvananthapuram main road, Palayamkottai, Tirunelveli
Government Siddha Medical College and Hospital, Tiruvananthapuram main road, Palayamkottai, Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9788122691 |
| Fax |
|
| Email |
komalaarumugam1@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD AND IPD FACILITIES AND CENTRAL LIBRARY OF GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL, TIRUVANANTHAPURAM MAIN ROAD, PALAYAMKOTTAI, TIRUNELVELI 627002,TAMILNADU, INDIA |
|
|
Primary Sponsor
|
| Name |
GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL |
| Address |
PG DEPARTMENT OF POTHU MARUTHUVAM, GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL, TIRUVANANTHAPURAM MAIN ROAD, PALAYMKOTTAI, TIRUNELVELI, TAMILNADU, INDIA |
| 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 |
| R SATHIYASEELAN |
Government Siddha Medical College and Hospital |
Op number 10,PG department of Pothu Maruthuvam, Government Siddha Medical College and Hospital, Tiruvananthapuram main road, Palayamkottai, Tirunelveli
Tirunelveli
TAMIL NADU |
8838637992
sathiyastar4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE , GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL, PALAYAMKOTTAI |
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 |
Lavangapattai Kudineer |
DOSAGE:110 ml Trice a day for 10 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.Patient having 2nd, 3rd degree internal haemorrhoids.
2.Pregnancy.
3.Fissure in ano.
4.Fistula in ano
5.Rectal Malignancy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The outcome will be aimed at reducing the symptoms of Raththa Moolam(Bleeding Hemorrhoids) and to determine the therapeutic efficacy of clinical trail drug ( Lavangapattai Kudineer) |
The outcome will be aimed at reducing the symptoms of Raththa Moolam(Bleeding Hemorrhoids) and to determine the therapeutic efficacy of clinical trail drug ( Lavangapattai Kudineer) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To collect various siddha literatures and modern journals.
2.To evaluate Physiochemical, Phytochemical, Bio Chemical analysis.
3.To evaluate safety profile for acute and sub-acute toxicity of trial drug LAVANGAPATTAI KUDINEER.
4.To study styptic activity of LAVANGAPATTAI KUDINEER.
5.To evaluate siddha parameter and compare the (including Envagai thervu) changes in RATHTHAMOOLAM during trial period.
6.To evaluate modern parametric changes in Raththa Moolam patients.
7.To evaluate the Bio statistical analysis. |
6 months |
|
|
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)
|
27/05/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is A PROSPECTIVE OPEN LABELLED, SINGLE ARM, NON- RANDOMIZED, SINGLE CENTRIC, PHASE II CLINICAL TRIAL TO DETERMINE THE EFFECTIVENESS OF LAVANGAPATTAI KUDINEER IN THE MANAGEMENT OF RATHTHA MOOLAM( BLEEEDING HEMORRHOIDS ). After purification of the trial drug ,LAVANGAPATTAI KUDINEER is prepared and administered at the dosage of 110ml trice a day for 10 days, which is given to 40 Raththa moolam patients (20 OP and 20 IP Patients). The primary outcome will be to determine the therapeutic efficacy of LAVANGAPATTAI KUDINEER in the management of RATHTHA MOOLAM( BLEEDING HEMORRHOIDS). The secondary outcome is to collect various siddha literatures and modern journals, to evaluate Physiochemical, Phytochemical, Bio Chemical analysis, to evaluate safety profile for acute and sub-acute toxicity of trial drug LAVANGAPATTAI KUDINEER, to study anti-microbial activity for selected micro-organism to the LAVANGAPATTAI KUDINEER, to evaluate siddha parameter and compare the (including Envagai thervu) changes in RATHTHAMOOLAM during trial period, to evaluate modern parametric changes in Raththa Moolam patients, to evaluate the Bio statistical analysis. |