Homeopathic treatment of gastric troubles

Phase 3

Recruiting

Conditions: Functional dyspepsia

Registration Number: CTRI/2018/04/013447

Lead Sponsor: National Institute of Homoeopathy Ministry of AYUSH Govt of India

Brief Summary: Functional dyspepsia is a clinical syndrome characterized by chronic or recurrent upper abdominal pain or discomfort having no identifiable cause. Symptoms should be present for a minimum of 3 months; however, symptoms for greater than 6 months are typical. This disorder is not a mono-symptomatic entity; several predominant symptoms may be present, including epigastric pain (22%), abdominal fullness (24%), bloating (15%), vomiting (3%), belching (8%), early satiety (12%), nausea (10%), and heartburn (6%). Individuals with functional dyspepsia suffer significant morbidity and expend significant resources through both direct and indirect costs. Despite periods of remission, patients will usually have continued intermittent symptoms long-term, with approximately 50% consulting a health care provider for their symptoms at some time in their life. Medical treatment options for functional dyspepsia remain limited. In addition, up to 60% of patients respond to placebo, which further limits tests of pharmaceutical effectiveness in this patient population. Thus controversies regarding efficacy of the mainstay pharmacological agent and inadequacy of outcomes, people frequently refer to CAM therapies and homeopathy, but published researches on such treatment is sparse. A literature search found few evidences relating to the treatment of dyspepsia with homeopathy. Different plant extracts in the form of mother tinctures are frequently prescribed as additive to individualized remedies in homeopathy to treat dyspepsia; however, those have neither been systematically documented, nor were their efficacy and indications verified till date. In this open, randomized, prospective, parallel arm, clinical trial, 128 patients suffering from functional dyspepsia will be randomized to either individualized homeopathy plus mother tincture arm (verum; IH + MT; n=64) or individualized homeopathy alone (control; IH; n=64). Outcomes will be measured in terms of Leeds dyspepsia questionnaire, measured at baseline, after 2 months and 4 months, and frequency of add-on standard conventional drugs for functional dyspepsia during study period of 4 months. Comparative analysis will be carried out in the end to detect group differences, if any. Results will be published in scientific journals.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 128

Inclusion Criteria

Age 18-65 years 2.
Both sexes 3.
Functional dyspepsia as per the Rome III criteria: One or more of the following for the last 3 months with symptom onset at least 6 months prior to diagnosis â€“ a) Bothersome postprandial fullness b) Early satiation c) Epigastric pain d) Epigastric burning And, no evidence of structural disease (including at upper endoscopy) that is likely to explain the symptoms.
Patients already undergoing regular therapy for dyspeptic ailments, provided the medications are stopped completely at least 2 weeks prior study entry 5.
Providing written informed consent 6.
Literate patients; ability to read English and/or Bengali.

Exclusion Criteria

Recent significant GI surgery within last 6 months 2.
Patients who are too sick for consultation 3.
Unable to read patient information sheet 4.
Unwilling to take part and not giving consent to join the study 5.
Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life 6.
Pregnancy and lactation 7.
Substance abuse and/or dependence 8.
Undergoing homeopathic treatment for any chronic disease within last 6 months.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Translated Bengali version of Leeds dyspepsia questionnaire	Baseline, after 2 months and after 4 months

Secondary Outcome Measures

Name	Time	Method
Frequency of use of standard conventional drugs for functional dyspepsia	4 months

Trial Locations

Locations (1): National Institute of Homoeopathy, Govt. of India
🇮🇳
Kolkata, WEST BENGAL, India
National Institute of Homoeopathy, Govt. of India
🇮🇳Kolkata, WEST BENGAL, India
Abhijit Chattopadhyay
Principal investigator
7003547446
drac.nih@gmail.com