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CTRI Number  CTRI/2024/05/067586 [Registered on: 17/05/2024] Trial Registered Prospectively
Last Modified On: 06/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Siddha 
Study Design  Single Arm Study 
Public Title of Study   Seenthil choornam 
Scientific Title of Study   A clinical study to evaluate the effectiveness of siddha Herbal Formulation Seenthil Choornam IN THE treatment OF erigunmam(acid peptic disease) 
Trial Acronym  SC 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrVSDeepthy 
Designation  PG scholar  
Affiliation  National Institute of Siddha 
Address  Department of Maruthuvam National Institute of Siddha Chennai 47

Kancheepuram
TAMIL NADU
600047
India 
Phone  9080311310  
Fax    
Email  deepthyrathan665@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrHVetha merlin kumari 
Designation  Associate professor 
Affiliation  National Institute of Siddha 
Address  Department of Maruthuvam National Institute of Siddha Chennai 47

Kancheepuram
TAMIL NADU
600047
India 
Phone  9894782366  
Fax    
Email  dr.vetha@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrHVetha merlin kumari 
Designation  Associate professor 
Affiliation  National Institute of Siddha 
Address  Department of Maruthuvam National Institute of Siddha Chennai 47

Kancheepuram
TAMIL NADU
600047
India 
Phone  9894782366  
Fax    
Email  dr.vetha@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Siddha tambaram sanatorium chennai 47 india 
 
Primary Sponsor  
Name  National Institute of Siddha 
Address  National Institute of Siddha Tambaram Sanatorium Chennai 47 india  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr V S Deepthy  Ayothidoss pandithar hospital  room no 7 8 OPD maruthuvam department
Kancheepuram
TAMIL NADU 
9080311310

deepthyrathan665@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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  Seenthil chooranam  Seenthil chooranam is indicated for gunmam and advised to take for 48 days with honey  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patient who are having symptoms of Eri Gunmam burning sensation
in epigastric region colic pain increased salivation flatulence
Burping headache diarrhea Any of 3 symptoms for the duration of
3 months by GSRS scale
Patient who are willing to give blood samples before & after treatment 
 
ExclusionCriteria 
Details  Gastric CA
Liver disorders
Cardiac disease
Uncontrolled diabetes
Pregnancy Lactation 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Primary outcome is assessed by comparing the reduction of clinical symptoms before and after
treatment by using Gastrointestinal symptoms rating scale GSRS 
12 MONTHS 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   30/05/2024 
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 Yet Recruiting 
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   BACKGROUND
The siddha system is based on a combination of ancient medicinal practices
and spiritual disciplines as well as alchemy and mysticism Siddha is the only system
comprising 64 varieties of medicines i e 32 classifications of internal and 32 classifications
of external medicines Yugi classified diseases based on signs and symptoms In his text
book of Yugi vaithiya chinthamani he classified the gunmam into 8 types One among
them is Eri Gunmam  Its signs and symptoms may be correlated with the Acid Peptic
Disease in modern medicine
The characteristic features of eri gunmam is burning sensation in epigastric
region colic pain increased salivation flatulence burping headache and diarrhoea
Acid Peptic Disease is a set of conditions characterised by an imbalance
between acid secretion and gastric mucosal defenses which can manifest as gastric ulcers
duodenal ulcers and gastro esophageal reflux disease are commonly occurring conditions
Acid Peptic diseases results from distinctive but overlapping pathogenic
mechanisms that typically involve acid effects on diminished mucosal defense Conditions
such as acid reflux can damage the esophageal mucosa Most ulcers occur in stomach and
proximal duodenum while less commonly in the lower esophagus the distal duodenum or
the jejunum Signs and symptoms of peptic ulcer diseases are epigastric pain Bloating
Abdominal fullness  nausea vomiting and weight loss

PRIMARY OBJECTIVE
To determine the clinical effectiveness of the Siddha formulation SEENTHIL
CHOORNAM Internal in the management of Eri Gunmam Acid Peptic disease through
open clinical study by using Gastro-intestinal system rating scale
STUDY DESIGN
Study type  An experimental study
Study design  An open clinical trial
Study place OPD of Ayothidoss Pandithar Hospital
National Institute of Siddha
Tambaram Sanatorium
Chennai47
Study period 12 Months
Sample size  30
INCLUSION CRITERIA
Age 20 60 years
Gender Male Female  Transgender
 Patient who are having symptoms of Eri Gunmam burning sensation
in epigastric region colic pain increased salivation flatulence
Burping headache diarrhea (Any of 3 symptoms) for the duration of
3 months by GSRS scale
 Patient who are willing to give blood samples before and after treatment

EXCLUSION CRITERIA
Known case of
Gastric CA
Liver disorders
Cardiac disease
Uncontrolled diabetes
Pregnancy & Lactation
PRIMARY OUTCOME
Primary outcome is assessed by comparing the reduction of clinical symptoms before and after
treatment by using Gastrointestinal symptoms rating scale (GSRS)
Results and discussion The results will be statistically analysed and reported
 Keywords
Gunmam acid peptic disease siddha formulation gastric ulcer
 
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