Evaluation of a herbal formulation on symptoms of gastro esophageal reflux disease.

Clinical study to study the safety and effect of a herbal formulation DRDC/2022/040 on symptoms of gastro oesophageal reflux disease â?? An open label, non-comparative, interventional, prospective study - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/07/055642

Enrollment

Registered

2023-07-25

Start date

Unknown

Completion date

Unknown

Last updated

2023-08-21

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

Conditions

Health Condition 1: K219- Gastro-esophageal reflux disease without esophagitis

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects of either sex in the age group of 18 to 60 years, both inclusive. 2. Subjects having average moderate reflux score (items 2 and 3) of Gastrointestinal symptoms rating scale (GSRS) [Appendix 2] 3. Subjects willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Known cases of diseases like gastric ulcer, duodenal ulcer, Gastric Ca etc. 2. Subjects who undergone abdominal surgeries. 3. Subjects with an anticipated need for concomitant medication with anticholinergics, promotility agents, prostaglandin analogs, sucralfate, nonsteroidal anti-inflammatory drugs (NSAIDs), or salicylates 4. Chronic alcoholics and Habitual Tobacco chewers. 5. Known cases of Severe/Chronic hepatic or renal disease. 6. Known subject of any active malignancy. 7. Subjects giving history of significant cardiovascular event 8. Subjects having known chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV. 9. Known subjects of having active metabolic or gastrointestinal diseases that may interfere with nutrient absorption, metabolism, or excretion, excluding diabetes. 10. Subjects using any other investigational drug within 1 month prior to recruitment or Subjects currently participating in any other Clinical study 11. Known hypersensitivity to any of the ingredients used in study drug 12. Pregnant and Lactating females. 13. Any other condition due to which patients are deemed to be unsuitable by the investigator for reason(s) not specifically started in the exclusion criteria

Design outcomes

Primary

Measure	Time frame
Assessment of time to onset of action & duration of action of DRDC/2022/040 with respect to relief from heartburn in subjects suffering from gastro oesophageal reflux diseaseTimepoint: Baseline & End of Study	—

Secondary

Measure	Time frame
Changes in 8 symptoms of gastroesophageal reflex disease including 1. burning sensation in throat, 2. sour taste in the mouth, 3. burning sensation in the chest, 4. epigastric (upper abdomen) discomfort, 5. burning sensation in the stomach, 6. bitter taste in the mouth, 7. nausea & 8. bloating, as per subject assessment on VAS. 2. Global assessment for overall change by subjects & investigator at the end of the study treatment 3. Assessment of safety based on clinical adverse events and vitals Timepoint: Screening, Baseline & End of Study	—

Measure

Time frame

Changes in 8 symptoms of gastroesophageal reflex disease including 1. burning sensation in throat, 2. sour taste in the mouth, 3. burning sensation in the chest, 4. epigastric (upper abdomen) discomfort, 5. burning sensation in the stomach, 6. bitter taste in the mouth, 7. nausea & 8. bloating, as per subject assessment on VAS. 2. Global assessment for overall change by subjects & investigator at the end of the study treatment 3. Assessment of safety based on clinical adverse events and vitals Timepoint: Screening, Baseline & End of Study

—

Countries

India

Contacts

Public ContactDr Sasibhushan Vedula

Target Institute Of Medical Research (TIMER)

targetinstitute@yahoo.com9322522252

Outcome results