A randomized clinical trial to evaluate the effectiveness of polyherbal formulation in Dyspepsia

A double blind four arm Randomized controlled Clinical trial to evaluate the effectiveness of poly herbal formulations in the management of Dyspepsia

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/03/050556

Enrollment

300

Registered

2023-03-10

Start date

Unknown

Completion date

Unknown

Last updated

2024-12-09

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

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Clinical presentation of Dyspepsia symptoms 2. Patients with either sex, 18 to 75 years age 3. All patients must agree not to share medication 4. Patients willing to participate and sign an informed consent 5. Understands and agrees to comply with planned study 6. Agrees to provide sample for testing as per protocol

Exclusion criteria

Exclusion criteria: 1. Chronic, Severe, Unstable, Uncontrolled co-existent Medical illness such as Diabetes, Hypertension, Cardiac disorders, liver, kidney disorders and lung Disorders or other disease of concern which may put the patient at increased risk during the study 2. Active cancer diagnosis, on palliative treatment or Requiring current therapy with antimetabolic agents, immunotherapy or radiotherapy. 3. Patients on parenteral nutrition 4. Patients with known sensitivity or contraindication to any of the ingredients of study medication 5. History of bleeding haemorrhoids, haemoptysis, acid peptic diseases, ulcers and pulmonary diseases (tuberculosis, asthma, etc.) 6. Pregnancy and lactation 7. Participation in a drug interventional clinical drug trial of any nature in the three month period 8. Patients who are either on Allopathy medicines or on other AYUSH medications 9. Dyspepsia of all organic origin 10. Physician decision that involvement in the study is not in the patient´s best interest.

Design outcomes

Primary

Measure	Time frame
The comparator drug "Pancharishta" is effective in managing DyspepsiaTimepoint: Baseline, 15th day, 30th day, 45th day and on 60th day	—

Secondary

Measure	Time frame
Poly herbal formulations will be effective in managing the quality of life And Psychological wellbeing in subjects of DyspepsiaTimepoint: Baseline, 15th day, 30th day, 45th day and on 60th day	—

Countries

India

Contacts

Public ContactDr Sumit Srivastava

Shri Dhanwantry Ayurvedic College and Hospital, Sector 46-B, Chandigarh

research@sdach.ac.in7986502791

Outcome results