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A study to assess the effects of GutGard in the management of Helicobacter pylori

A randomized double blind placebo controlled trial of NR/GG/01 (GutGard?) in the management of Helicobacter pylori

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2011/08/001968
Enrollment
100
Registered
2011-08-24
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: null- H.pylori gastric load

Interventions

Intervention1: Extract of Glycyrrhiza glabra: One capsule (150 mg actives) per day for 60 days Compared with Placebo one capsule (0 mg actives) per day for 60 days Control Intervention1: placebo: Comp

Sponsors

NICS CO LTD
Lead Sponsor
Natural Remedies Pvt Ltd
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects aged 18 - 45 years 2. H. pylori 13C urea breath test (positive Greaterthan/Equalto 4.0 Plus/Minus 0.4 DOB) 3. H. pylori positive in stool test

Exclusion criteria

Exclusion criteria: 1. History/Diagnosed with bleeding duodenal ulcer 2. Advanced chronic illness that would impair follow-up or monitoring. 3. Pregnancy or breast feeding. 4. Previous surgery for ulcers. 5. History of MALT lymphoma 6. First level relatives of gastric cancer patients 7. Subjects with previous history of gastroesophageal reflux 8. Subjects with concomitant symptoms of the irritable bowel syndrome. 9. Drug and alcohol abuse. 10. Use of oral antibiotics and/or PPIs and/or H2-antagonists during the 2 weeks prior to ingestion of the study product 11. Patients using non-steroidal anti-inflammatory drugs, steroids, bismuth preparation 12. Mental illness or dementia. 13. Participation in other clinical trials

Design outcomes

Primary

MeasureTime frame
Decrease in the H.pylori gastric load in the treatment group compared to placebo by change in the severity of symptomsTimepoint: 45 days

Secondary

MeasureTime frame
Change in the severity of symptoms measured by 7-point likert scaleTimepoint: 60 days

Countries

India

Contacts

Public ContactSanthosh Kumar

D2L Pharma Research Solutions

shekhar.gupta@d2lpharma.com08042050651

Outcome results

None listed

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