Evaluation of Efficacy & Safety of Ayurvedic formulations "Active Antacid Suspension" and "Active Antacid Tablets" in management of acidity and indigestion

A randomized controlled open label clinical study to evaluate the safety and efficacy of Active Antacid Suspension (DRF/AY/5018) and Active Antacid Tablets(DRF/AY/4026) in comparison with standard modern treatment in management of hyperacidity and functional dyspepsia

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/08/009285

Enrollment

127

Registered

2017-08-07

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: K30- Functional dyspepsia

Interventions

Intervention1: Active antacid suspension (DRF/AY/5018): Polyherbal antacid suspension comprising Glycyrrhiza glabra, Tinospora cordifolia, Eclipta alba, Operculina turpethum Dose: 15 ml TDS and SOS I

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male or Female subjects in the age group of 20 years to 50 years. 2. Subjects with greater than or equal to 24% of dyspepsia as per the Hong Kong Index of Dyspepsia 3. Subjects with absence of any clinical or ultrasonographic evidence of organic disease that was accounted for the symptoms 4. Subjects who were willing to sign informed consent and to come for regular followup examinations as & when required. 5. In the event of subject undergoing treatment for dyspepsia, washout period of 2 days was given prior to inclusion.

Exclusion criteria

Exclusion criteria: 1.Subjects with presence of or history of peptic and duodenal ulcers disease or gastric malignancy any gastrointestinal surgery, reflux oesophagitis, any upper or lower G.l. bleeding, with clinical evidence of irritable bowel syndrome or any psychiatric disease. 2. Subjects with clinically diagnosed serious medical or surgical illness (like: Diabetes, CAD, HT, SLE, Rheumatoid Arthritis, Psoriatic Arthritis) where compliance was difficult. 3. Subjects not willing to follow up for the study visits. 4. Subjects with age range below 20 years and above 50 years 5. Uncooperative Subjects or subjects not willing to sign Informed Consent or giving consent for study required procedure like endoscopy.

Design outcomes

Primary

Measure	Time frame
1. To evaluate the efficacy of Antacid Tablet (DRF/AY/4026 ) Antacid Suspension (DRF/AY/5018) in the Management of the Hyperacidity & Functional Dyspepsia in comparison to a marketed comparator. Timepoint: day 7,14,21,28,35,42	—

Secondary

Measure	Time frame
To evaluate overall subject safetyTimepoint: day 7,14,21,28,35,42	—

Countries

India

Contacts

Public ContactDr Arun Gupta

Dabur India Ltd.

arun.gupta@dabur.com120337862314

Outcome results

None listed

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