A comparative study of Dhanyakadi Churna and Panchnimbadi Churna in 62 patients of Urdhwag Amlapitta or Gastro Oesophageal Reflux Disease.

Phase 3

Not yet recruiting

• Conditions: Gastro-esophageal reflux disease without esophagitis. Ayurveda Condition: AMLAPITTAM,

• Registration Number: CTRI/2025/05/086950
• Lead Sponsor: Seth R V Ayurved Hospital

Brief Summary

The primary objective of this open, randomized, comparative clinical study is to evaluate and compare the efficacy of Dhanyakadi Churna and Panchnimbadi Churna in the management of Urdhwag Amlapitta, a condition in Ayurveda correlating with gastroesophageal reflux disease (GERD), characterized by symptoms such as indigestion, nausea, sour belching, burning sensations in the chest and throat, and fatigue. Rooted in Ayurvedic principles, Urdhwag Amlapitta is believed to arise from the vitiation of Pitta dosha due to lifestyle and dietary factors. This clinical trial includes 62 patients, randomly assigned into two groups (31 each), with both groups receiving their respective churna at a dose of 3 grams twice daily for 21 days, administered with honey. The primary hypothesis posits that both formulations are equally effective in treating Urdhwag Amlapitta, while secondary hypotheses explore whether one treatment demonstrates superior efficacy over the other. The study seeks to provide scientific evidence for the use of these Ayurvedic formulations as viable alternatives to conventional pharmacological treatments.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-02-06
• Last Update Posted: 2025-08-05

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Not specified
• Target Recruitment: 62

Inclusion Criteria

• Age 18 to 60 years Gender All genders Symptoms Urdhwag Amlapitta Hrit Kantha Dah, Tikt Amlodgar, Utklesha, Avipak, Aruchi, Klama.
• Compliance Patients who are willing and able to adhere to the study protocol, including prescribed treatments and follow-up schedules.
• Health Status Patients with no significant comorbidities that could interfere with the Study outcomes or the safety of the participant, as determined by a clinical assessment.
• Medication History Patients who have not used any other Ayurvedic or allopathic treatments for Urdhwag Amlapitta in the past two weeks.

Exclusion Criteria

Pregnancy and Lactation Psychiatric Disorders Chronic or Severe Medical Conditions Recent Surgery Current Use of Confounding Medications Substance Abuse Participation in Other Trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Utklesha	3 weeks
Avipak	3 weeks
Hrit Kantha daha	3 weeks
Tikta amlodgar	3 weeks
Aruchi	3 weeks
Klama	3 weeks

Trial Locations

Locations (1)

Seth R V Ayurved College and Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Seth R V Ayurved College and Hospital

🇮🇳Mumbai, MAHARASHTRA, India

Dr Nisha Sahebrao Tarte

Principal investigator

09082901128

tartenisha27@gmail.com