A clinical study on Saamuthara chooranam for Eri Gunmam(Peptic ulcer disease)

Phase 2

Not yet recruiting

• Conditions: Peptic ulcer, site unspecified, unspecified as acute or chronic, without hemorrhage or perforation,

• Registration Number: CTRI/2019/05/019164
• Lead Sponsor: Government Siddha Medical College and Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-17
• Last Update Posted: 2019-10-05

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
b)heart burn	45days
h)water brash	45days
The outcome is reduction in clinical symptoms of	45days
c)vomiting	45days
d)nausea	45days
e)belching	45days
f)indigestion	45days
a)epigastric pain	45days
g)bloating of abdomen	45days

Secondary Outcome Measures

Name	Time	Method
1.Evaluation of pharmacological activity of saamuthara chooranam	2.Evaluation of siddha parameters changes in Erikunmam during trial period

Trial Locations

Locations (1)

Government Siddha Medical College and Hospital; 🇮🇳 Tirunelveli, TAMIL NADU, India

Government Siddha Medical College and Hospital

🇮🇳Tirunelveli, TAMIL NADU, India

M Ahkalya

Principal investigator

7604874176

drahkalya@gmail.com