Abstract

SAFETY AND EFFICACY OF TRIPHALA CAPLETS IN MILD OCCASIONAL CONSTIPATION ASSOCIATED WITH COMMON DIGESTIVE PROBLEMS: A RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED CLINICAL STUDY

Dr. R. K. Sharma and Dr. Pallavi Borah, *Dr.D.Palaniyamma.

Abstract

The present study was planned to evaluate the clinical efficacy and safety of Triphala Caplets in individuals with mild occasional constipation associated with common digestive problems in a randomized double blind placebo controlled clinical study. A total of fifty subjects between 18 to 65 years with mild occasional constipation associated with common digestive problems were included in the study provided they were able to attend the trial on all the assessment visits, willing to give the informed consent. After obtaining informed consent, baseline history was obtained which included personal data, a description of symptoms and details of past medical history, family history etc. Thereafter all subjects underwent a clinical examination and laboratory investigation including Haemoglobin, Total Count, Erythrocyte sedimentation rate, platelet count, creatinine, Serum Glutamic Pyruvic Transaminase and Serum Glutamic Oxalacetic Transaminase. Subjects were randomized into Group A (n=25) or Group B (n = 25). Each subject in Group A received Triphala at a dose of 1 caplet once daily for 4 weeks. Subjects in Group B received similarly looking placebo at the same dose. Subjects were evaluated with Patient assessment questionnaire for constipation (PAC-QOL) to measure the impact of constipation on daily life. Statistical analysis was carried out using GraphPad Prism, Version 4.03 for windows, Graphpad Software, San Diego, California, USA. All the subjects completed the study and their data was available for analysis. Significant evidence in relief of symptoms with respect to PAC-QOL evaluation in constipation associated with digestive disorders in terms of clinical response and reduction in biochemical parameters were observed after 4 weeks of treatment. The clinical and biochemical parameters were found to be within the normal limits in both the groups before and after treatment. There were no clinically significant adverse reactions either reported or observed during the entire study period. The overall compliance to the treatment was good and no treatment discontinuations were reported. The results of the present study showing clinical benefit of Triphala appear promising in relieving symptoms of constipation associated with digestive problems.

Keywords: Constipation, Triphala, digestive problem.