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Randomized Controlled Trial
. 2018 Mar 20;18(1):98.
doi: 10.1186/s12906-018-2168-y.

A poly-herbal blend (Herbagut®) on adults presenting with gastrointestinal complaints: a randomised, double-blind, placebo-controlled study

Adrian L Lopresti  1 , Hemant Gupta  2 , Stephen J Smith  3
Affiliations
Randomized Controlled Trial

A poly-herbal blend (Herbagut®) on adults presenting with gastrointestinal complaints: a randomised, double-blind, placebo-controlled study

Adrian L Lopresti et al. BMC Complement Altern Med. .

Abstract

Background: To evaluate the efficacy and tolerability of a poly-herbal formulation, Herbagut, for the treatment of gastrointestinal symptoms and its effect on quality of life parameters in patients presenting with self-reported, unsatisfactory bowel habits.

Methods: This was a randomised, double-blind, placebo-controlled trial. Fifty adults with self-reported unsatisfactory bowel habits, primarily characterised by chronic constipation were randomly allocated to take Herbagut or a matching placebo for 28 days. Efficacy of gastrointestinal changes was measured by the completion of a patient daily diary evaluating changes in stool type (Bristol Stool Form Scale), ease of bowel movements, and feeling of complete evacuation; and the Gastrointestinal Symptom Rating Scale (GSRS). Changes in quality of life were also examined using the World Health Organization Quality of Life - abbreviated version (WHOQOL-BREF), and the Patient Assessment of Constipation-Quality of Life (PAC-QOL).

Results: All participants completed the 28-day trial with no adverse events reported. Compared to the placebo, weekly bowel movements increased over time (p < .001), as did self-reported, normal bowel motions (76% vs 4%; p < .001). Self-reported incomplete evacuation was also lower in the Herbagut group compared to placebo (24% vs 76%; p = <.001). GSRS domain ratings for abdominal pain, constipation, diarrhoea, indigestion, and reflux also decreased significantly in people taking Herbagut compared to placebo (p < .001, for all domains). Moreover, quality of life significantly improved in the Herbagut group compared to placebo as indicated by significantly greater improvement in WHOQOL-BREF domain ratings for overall quality of life, social relations, environmental health, psychological health, and physical health (p < .001, for all domains); and PAC-QOL domain ratings for physical discomfort, psychosocial discomfort, worries and concerns, and life satisfaction (p < .001, for all domains). The changes were considered clinically meaningful as evidenced by their large effect sizes.

Conclusion: Herbagut ingestion over a 28-day period resulted in improvements in several gastrointestinal symptoms and overall quality of life. Further investigation utilising larger sample sizes and diverse clinical and cultural populations are needed.

Trial registration: Clinical Trials Registry- India /2016/11/007479 . Registered 24 April 2015 (retrospectively registered).

Keywords: Clinical trial; Constipation; Digestion; Gastrointestinal function; Herbal treatment.

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Conflict of interest statement

Ethics approval and consent to participate

The study protocol was approved by ‘Nagpur Independent Ethics Committee’ and all participants provided informed consent.

Consent for publication

Not applicable.

Competing interests

This study was independently managed by the principal investigator, Dr Hemant Gupta, who declares no competing interests. Dr Adrian Lopresti has received study funding from Arjuna Natural Extracts Ltd in the past for previously completed, unrelated studies. Mr Stephen Smith declares no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Systematic Illustration of Study design
Fig. 2
Fig. 2
GSRS domain ratings over time. formula image
Fig. 3
Fig. 3
WHOQOL-BREF domain ratings over time. formula image
Fig. 4
Fig. 4
PAC-QOL domain ratings over time. formula image
See this image and copyright information in PMC

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