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CTRI Number  CTRI/2019/05/019164 [Registered on: 15/05/2019] Trial Registered Prospectively
Last Modified On: 10/05/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Siddha 
Study Design  Single Arm Study 
Public Title of Study   A clinical study on Saamuthara chooranam for Eri Gunmam(Peptic ulcer disease) 
Scientific Title of Study   A Prospective open labelled, Non-randomized ,phase II,clinical trial of Saamuthara 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  M Ahkalya 
Designation  PG Scholar 
Affiliation  Government Siddha Medical College and Hospital Palayamkottai 
Address  II year PG Scholar Department of Pothu maruthuvam Government Siddha Medical College and Hospital Palayamkottai Tirunelveli TamilNadu

Tirunelveli
TAMIL NADU
627002
India 
Phone  7604874176  
Fax    
Email  drahkalya@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr A Manoharan MD PhD 
Designation  Professor and HOD 
Affiliation  Government Siddha Medical College and Hospital 
Address  Department of Pothu maruthuvam Government Siddha Medical College and Hospital Palayamkottai Tirunelveli

Tirunelveli
TAMIL NADU
627002
India 
Phone  9443886700  
Fax    
Email  drmanoharan@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr G Subashchandran MD PhD 
Designation  Lecturer Grade II 
Affiliation  Government Siddha Medical College and Hospital 
Address  Department of Pothu maruthuvam Government Siddha Medical College and Hospital Palayamkottai Tirunelveli

Tirunelveli
TAMIL NADU
627002
India 
Phone  9443358271  
Fax    
Email  siddhadrgs21@gmail.com  
 
Source of Monetary or Material Support  
IPD and OPD facilities and central library of Government Siddha Medical College and Hospital Palayamkottai 
 
Primary Sponsor  
Name  Government Siddha Medical College and Hospital  
Address  Palayamkottai Tirunelveli Tamilnadu 627 002 
Type of Sponsor  Government medical college 
 
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 
M Ahkalya  Government Siddha Medical College and Hospital  OP number 10 PG Department of Pothu maruthuvam Government Siddha Medical College and Hospital Palayamkottai
Tirunelveli
TAMIL NADU 		 7604874176

drahkalya@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  
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  Saamuthara chooranam   180mg/Kg/BW/Twice a day A/F with Ghee for 45days 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients having symptoms of with
a)epigastric pain
b)heart burn
c)nausea
d)vomiting
e)belching
f)water brash
g)lose of weight
h)indigestion
i)bloating of abdomen
2.Patients who are willing to take upper gastro-interstinal
endoscopy
3.Patients who are willing to give blood specimen for laboratory investigation when required  
 
ExclusionCriteria 
Details  1.Pregnancy
2.Lactating mother
3.Recent malignancy or radiation therapy
4.Gastro esophageal refulx disease
5.Pancreatitis
6.Inflammatory bowel disease
7.Acute hepatitis
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The outcome is reduction in clinical symptoms of
a)epigastric pain
b)heart burn
c)vomiting
d)nausea
e)belching
f)indigestion
g)bloating of abdomen
h)water brash  		 45days 
 
Secondary Outcome  
Outcome  TimePoints 
1.Evaluation of pharmacological activity of saamuthara chooranam
2.Evaluation of siddha parameters changes in Erikunmam during trial period
3.Determination of safety profile of trial drug
4.Study about the prevalence of Erikunmam in relation between diet and life style  		 45days 
 
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)   17/05/2019 
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   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   The study is a prospective open labelled non randomised phase II clinical trial to determine the efficacy and safety of Saamuthara Chooranam  in patients with Erigunmam(Peptic Ulcer Disease).In this clinical trial to be held at GSMC,Palayamkottai 60 patients (30 in OPD + 30 in IPD) will be recruited and the trial drug will be administered at the dose of 180mg/kg/BW/Twice a day/ (orally) A/F along with ghee as adjuvant for a period of 45 days.All the study related data will be recorded and documented in a separate file for each patients.In case of any adverse event (AE) is noticed and it will be referred to pharmaco vigilence department of SCRI.Further management of patient will be given OPD,GSMC.During this trial all the efficacy and safety parameters will be recorded in the CRF.After completion of the trial all the study related data will be analysed statistically.
 
 
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