Clinical study on Ayucid Capsules in Acidity patients

An Open Label Randomized Comparative Multicenter Prospective Clinical Study to evaluate Efficacy and Safety of Ayucid Capsules and Omeprazole (20 mg) in Patients Suffering from Chronic symptomatic Gastro-esophageal Reflux Disease (GERD) - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/01/011260

Enrollment

Registered

2018-01-11

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: K219- Gastro-esophageal reflux disease without esophagitis

Interventions

Intervention1: Ayucid Capsules: Ayucid Capsules contains Mimosa Pudica, Asparagus racemosus, Emblica officinalis, Glycyrrhiza glabra,Woodfordia fruticosa, Fumaria parviflora, Pimpinella ansium, Hedych

Eligibility

Inclusion criteria

Inclusion criteria: 1.Subjects having history of heartburn equal to or more than 12 months and less than 5 years. 2.Subjects having GERD Questionnaire score equal to or more than 8. 3.Subjects with current episodes of moderate to severe heartburn on at least 4 occasions in the last 7 days prior to screening. 4.Subjects willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1.Subjects who are known to have 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 other than low-dose aspirin 4.Chronic alcoholics and Habitual Tobacco chewers. 5.Known cases of Severe or Chronic hepatic or renal disease. 6. Known subject of any active malignancy. 7. Subjects having known chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV. 8. Known hypersensitivity to any of the ingredients used in study drug. 9. Pregnant and Lactating females

Design outcomes

Primary

Measure	Time frame
Assessment of complete resolution of heartburn in two groupsTimepoint: Day -3, Day 0, Day 7, Day 14, Day 21, Day 28	—

Secondary

Measure	Time frame
1 Assessment of other symptoms of GERD 2 Assessment of requirement of rescue medication 3 Assessment of quality of life on GERD HRQL 4 Assessment of other digestion related symptoms 5 Assessment of safety based on clinical adverse events and laboratory test results 6 Global assessment for overall improvement by subject and investigator at the end of study treatment Timepoint: Day -3, Day 0, Day 7, Day 14, Day 21, Day 28	—

Measure

Time frame

1 Assessment of other symptoms of GERD 2 Assessment of requirement of rescue medication 3 Assessment of quality of life on GERD HRQL 4 Assessment of other digestion related symptoms 5 Assessment of safety based on clinical adverse events and laboratory test results 6 Global assessment for overall improvement by subject and investigator at the end of study treatment Timepoint: Day -3, Day 0, Day 7, Day 14, Day 21, Day 28

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Countries

India

Contacts

Public ContactVandana Bade

Target Institute of Medical Education and Research

targetinstitute@yahoo.com9322522252

Outcome results

None listed

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