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

An Open labelled, Single arm, clinical study to Evaluate Efficacy and Safety of GRACE HING (Hing oil 15 mg) HPMC Capsules in the Treatment of Abdominal Pain and Functional Dyspepsia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/05/042652
Enrollment
15
Registered
2022-05-19
Start date
Unknown
Completion date
Unknown
Last updated
2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K30- Functional dyspepsia

Interventions

Intervention1: Grace Hing (Hing oil 15mg) HPMC Capsules : Each HMPC Capsules contains: Hing Oil- 15 mg. Take 2 capsules per day along with the meal Control Intervention1: NA: NA

Sponsors

NUTRA GRACE
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
The primary outcome was a decrease in VAS for pain intensity.Timepoint: day 0 and day 30

Secondary

MeasureTime frame
To assess Adverse eventsTimepoint: Day 1 to Day 30;To assess Gastrointestinal Symptom Rating 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

Countries

India

Contacts

Public ContactMr Sunil Gupta

Pharexcel Consulting Private Limited

info@pharexcelconsulting.com09878551428

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026