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To Evaluate the Safety and Efficacy of HODT101510A in Indigestion: Open Label Clinical Study

To Evaluate the Safety and Efficacy of HODT101510A in Indigestion: Randomized, Open Label, One Arm Clinical Study - QDEE-IND

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/02/017532
Enrollment
40
Registered
2019-02-07
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: K00-K95- Diseases of the digestive system

Interventions

Intervention1: QDEE-Indigestion: Pro digestive MDT will help relieve the digestive complaints. It is recommended in people having symptoms like, loss of appetite, bloating, belching, abdominal discomf

Sponsors

The Himalaya Drug Company
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adult male and female subjects aged >=18 years presenting with either one or more of the following indigestion symptoms like Loss of appetite, nausea, bloating, belching, abdominal discomfort, flatulence. Subjects who are willing to withdraw from any other medication taken for indigestion. Subjects willing to sign informed consent and follow the study procedure. Subjects who has not participated in any similar kind of clinical study in the last one month.

Exclusion criteria

Exclusion criteria: Patients who took any other medications to relieve these symptoms within 2 weeks. Subjects with cardiac, neurological, renal or hepatic dysfunction. A known history or present condition of allergic response to products its components or to any of the ingredients in the test product. Pre-existing systemic disease requiring long-term medications. Pregnant & breast-feeding women.

Design outcomes

Primary

MeasureTime frame
â?¢ To clinically evaluate â??HODT101510Aâ?? in reducing the symptoms of indigestion in subjects with Loss of appetite, nausea, bloating, belching, abdominal discomfort, flatulence etc.Timepoint: The whole study duration is for 4 days with follow up visit at day 1, day 3 and day 5

Secondary

MeasureTime frame
â?¢ To assess the incidence of adverse events during the study period and overall compliance to the study intervention.Timepoint: The whole study duration is for 4 days with follow up visit at day 1, day 3 and day 5

Countries

India

Contacts

Public ContactDr Palaniyamma

The Himalaya Drug Company

dr.palani@himalayawellness.com

Outcome results

None listed

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