| CTRI Number |
CTRI/2022/02/040375 [Registered on: 17/02/2022] Trial Registered Prospectively |
| Last Modified On: |
14/02/2022 |
| 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 Vasambu Chooranam in the management of Erigunmam (PEPTIC ULCER DISEASE) |
|
Scientific Title of Study
|
A PROSPECTIVE OPEN
LABELLED,NON-RANDOMIZED,PHASE II CLINICAL TRIAL OF VASAMBU CHOORANAM IN THE MANAGEMENT OF ERI GUNMAM (PEPTIC ULCER DISEASE) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PGomathi |
| Designation |
PG scholar |
| Affiliation |
Government Siddha Medical College and Hospital Palayamkottai |
| Address |
PG Department of Pothu Maruthuvam OP NO.10
Government Siddha Medical College and Hospital Palayamkottai
Tirunelveli
PG Department of Pothu Maruthuvam OP no.10
Government Siddha Medical College and Hospital
Palayamkottai
Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
6381162926 |
| Fax |
|
| Email |
gomezz1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr A Manoharan MD s PhD |
| Designation |
Professor and HOD |
| Affiliation |
Government Siddha Medical College and Hospital Palayamkottai |
| Address |
PG Department of Pothu Maruthuvam OP No.10
Government Siddha Medical College and Hospital
Palayamkottai
Tirunelveli.
PG Department of Pothu Maruthuvam OP no.10
Government Siddha Medical College and Hospital
Palayamkottai
Tirunelveli.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443886700 |
| Fax |
|
| Email |
drmanoharan25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr A Manoharan MD s PhD |
| Designation |
Professor and HOD |
| Affiliation |
Government Siddha Medical College and Hospital Palayamkottai |
| Address |
PG Department of Pothu Maruthuvam OP no.10
Government Siddha Medical College and Hospital
Palayamkottai
Tirunelveli
PG Department of Pothu Maruthuvam 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 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 Tamilnadu |
| 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 |
| PGomathi |
Government Siddha Medical College and Hospital |
PG Department of Pothu Maruthuvam
OP no 10
Tirunelveli
TAMIL NADU |
6381162926
gomezz1997@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: K279||Peptic ulcer, site unspecified, unspecified as acute or chronic, without hemorrhage or perforation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
VASAMBU CHOORANAM |
0.5g - 1g twice a day (orally) A/F 45 days along with honey
as adjuvant |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients having symptoms of epigastric pain,heart burn,nausea,vomiting,loss of weight,water brash, indigestion and bloating of abdomen
2.Patients who are willing to take upper gastrointestinal endoscopy
3.Patients who are willing to give blood specimen and laboratory investigation when required |
|
| ExclusionCriteria |
| Details |
1.Pregnancy
2.lactating mother
3.Diabetes Mellitus
4.Recent malignancy or radiation therapy
5.Gastro esophageal reflux disease
6.Pancreatitis
7.Inflammatory Bowel Disease
8.Acute hepatitis
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
If during treatment or after treatment reduction of the following symptoms
1.Epigastric pain
2.heart burn
3.nausea
4.vomiting
5.water brash
6.loss of weight
7.indigestion
8.bloating of abdomen |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the biochemical and physio-chemical and phytochemical analysis of clinical trial drug
To evaluate the antimicrobial activity of trial drug
To evaluate the safety profile for acute and sub acute toxicity of the trial drug Vasambu Chooranam
To evaluate pharmacological analysis of the clinical trial drug
To evaluate siddha parameters and modern parameters during the treatment of Peptic Ulcer Disease with trial drug
To evaluate the statistical analysis of the clinical trial drug Vasambu Chooranam
To evaluate the powder microscopic study and HTPLC of the trial drug |
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)
|
24/02/2022 |
| 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 ll Non randomised clinical study to evaluate the therapeutic efficacy of Vasambu Chooranam in the management of Erigunmam(Peptic Ulcer Disease).The trial drug will be administered at the dose of 0.5g -1g twice a day (orally) A/F 45 days along with Honey 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 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 Pharamacovigilance department of SCRI.Further management of Patients will be given in OPD facility |