Homeopathic medicines in dyspepsia

Phase 3

Completed

Conditions: Functional dyspepsia,

Registration Number: CTRI/2021/08/036044

Lead Sponsor: Gurudev Choubey

Brief Summary: Functional dyspepsia (FD) is a clinical syndrome characterized by chronic or recurrent upper abdominal pain or discomfort with no identifiable cause. Symptoms should be present for a minimum of 3 months; however, symptoms lasting 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. The prevalence of FD is estimated to be 11.5-14.7%. A double-blind, randomized, placebo-controlled, two parallel arms clinical trial was conducted on 140 patients (70 in each group) suffering from FD at the outpatient department of Clinical Research Unit (Homoeopathy), Siliguri, under Central Council for Research in Homoeopathy, Ministry of AYUSH, Govt. of India; Gokhel Road, Arabindopally, Siliguri, Pin 734006, West Bengal. Patients were randomized in 1:1 ratio into either individualized homeopathic medicinal products (IHMPs) or identical-looking placebo. Outcome measures (primary â€“ Leeds dyspepsia questionnaire â€“ short form; secondary - frequency of use of standard conventional drugs for functional dyspepsia during study period of 3 months) were recorded at baseline, and every month, up to 3 months. The attrition rate was 9.3%. Group differences favored IHMPs against placebos in all the outcomes (LDQ-SF total: P < 0.001; LDQ-SF symptom frequency: P < 0.001; LDQ-SF symptom severity: P < 0.001, number of participants consuming antacids: P = 0.001; and the number of antacids consumed: P < 0.001), with large effect sizes. Nux vomica (18.6%), Sulphur (15%), Lycopodium clavatum (12.1%), Pulsatilla nigricans (6.4%), and Carbo vegetabilis (5%) were the most frequently prescribed remedies. IHMPs acted significantly better than placebos in the treatment of FD. Independent replications are required to validate the findings.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 140

Inclusion Criteria

1.Functional dyspepsia (ICD-10-CM Diagnosis Code K30) as per the Rome IV criteria 2..â€œPatients already undergoing regular therapy for dyspeptic ailments, provided the medications are stopped completely at least 2 weeks prior study entryâ€ 3..â€œLiterate patients; ability to read Bengali and/or Englishâ€ 4.Providing written informed consent.

Exclusion Criteria

1.Recent significant GI surgery within last 6 months 2.Patients who are too sick for consultation 3.Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life 4.Pregnancy, puerperium and lactation 5.Substance abuse and/or dependence 6.Self-reported immune-compromised state, and 7.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
Leeds Dyspepsia Questionnaire - Short Form (LDQ-SF)	Baseline, every month, up to 3 months

Secondary Outcome Measures

Name	Time	Method
Frequency of use of standard conventional drugs for functional dyspepsia during study period of 3 months	Baseline, every month, up to 3 months

Trial Locations

Locations (1): Clinical Research Unit for Homeopathy,Siliguri
🇮🇳
Darjiling, WEST BENGAL, India
Clinical Research Unit for Homeopathy,Siliguri
🇮🇳Darjiling, WEST BENGAL, India
Dr Gurudev Choubey
Principal investigator
7908955160
gurudev.choubey@gmail.com