A clinical trial on Vasambu Chooranam in the management of Erigunmam (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/2022/02/040375
• Lead Sponsor: Government Siddha Medical College and Hospital

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

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-02-14
• Study Start: 2022-02-24

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Epigastric pain	45 days
2.heart burn	45 days
3.nausea	45 days
If during treatment or after treatment reduction of the following symptoms	45 days
7.indigestion	45 days
4.vomiting	45 days
5.water brash	45 days
6.loss of weight	45 days
8.bloating of abdomen	45 days

Secondary Outcome Measures

Name	Time	Method
To evaluate the biochemical and physio-chemical and phytochemical analysis of clinical trial drug	To evaluate the antimicrobial activity of trial drug

Trial Locations

Locations (1)

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

Government Siddha Medical College and Hospital

🇮🇳Tirunelveli, TAMIL NADU, India

PGomathi

Principal investigator

6381162926

gomezz1997@gmail.com