study to Evaluate Efficacy and Safety of GRACE HING Asafotedia 15mg capsules in managing abdominal pain with cramping.

Not Applicable

Completed

Recruitment & Eligibility

Inclusion Criteria

1. Subjects of age group between 18-60 years are included in the study.

2. Subjects who are considered to healthy systemically without any

comorbidities and malignancy are included in the study.

3. Subjects fulfilling the Rome Diagnostic criteria are included in the study.

4. Subjects with abdominal pain irrespective of underlying diagnosis related

toGastro-Intestinal system are included in the study.

5. Subjects with complaints of frequent occurrences of abdominal pain due to

natureof the disease are included in the study.

6. Subjects who are willing to give informed consent without any hindrance

areincluded in the study.

Exclusion Criteria

1. Subjects below 18 years and above 60 years of age are excluded from the study.

2. Subjects with complaints of abdominal spasms due to other systemic diagnosis apart from Gastro-Intestinal systems such as

renal calculi, gall bladder stones, etc, are excluded from the study.

3. Subjects who are not willing to give informed consent are excluded from the study.

4. Subjects with co morbidities such as; Type 2 Diabetes mellitus, hypothyroidism, Hypertension are excluded from the study.

5.Subjects who have been diagnosed of chronic diseases such as cardiovascular diseases, cancer, respiratory conditions, orthopaedic conditions

associated with early and late complications are excluded from the study

6. Subjects who are associated with long tern usage of analgesics & who has pasthistory of Gastro-intestinal surgery are excluded from

the study.

7. Subjects with gastro or duodenal ulcers and are also afflicted with dysphagia &odynophagia are excluded from the study.

8. Subjects with persistent GI bleeding and frequent vomiting are excluded from the study.

Primary Outcome Measures

Name	Time	Method
The primary outcome was a decrease in VAS for <br/ ><br>pain intensity.Timepoint: day 0 and day 30

Secondary Outcome Measures

Name	Time	Method
To assess Adverse eventsTimepoint: Day 1 to Day 30;To assess Gastrointestinal Symptom Rating <br/ ><br>Scale(GSRS)Timepoint: Day 1 to Day 30;To assess Global overall symptom scaleTimepoint: Day 1 to Day 30;To assess the Nepean Dyspepsia Index (NDI)Timepoint: Baseline , Day 1 to Day 30