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Clinical Trials/CTRI/2024/05/067586
CTRI/2024/05/067586Not yet recruitingPhase 2

A clinical study to evaluate the effectiveness of siddha Herbal Formulation Seenthil Choornam IN THE treatment OF erigunmam(acid peptic disease)

National Institute of Siddha1 site in 1 country30 target enrollmentStarted: May 30, 2024Last updated:

Trial Snapshot

Phase
Phase 2
Status
Not yet recruiting
Enrollment
30
Locations
1
Primary Endpoint
Primary outcome is assessed by comparing the reduction of clinical symptoms before and after

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Na
Masking
None

Eligibility Criteria

Ages
20.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 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.

Exclusion Criteria

  • Gastric CA Liver disorders Cardiac disease Uncontrolled diabetes Pregnancy Lactation.

Outcomes

Primary Outcomes

Primary outcome is assessed by comparing the reduction of clinical symptoms before and after

Time Frame: 12 MONTHS

treatment by using Gastrointestinal symptoms rating scale GSRS

Time Frame: 12 MONTHS

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

DrVSDeepthy

National Institute of Siddha

Study Sites (1)

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