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study the effect of Amlyadhya Loham a herbo mineral formulation in Amlapitta (dyspepsia) or Hyperacidity

An Analytical & Clinical Study to evaluate the effect of Amladhya Loham in Amlapitta (Dyspepsia) - An open labelled single arm study - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/11/076917
Enrollment
30
Registered
2024-11-18
Start date
Unknown
Completion date
Unknown
Last updated
2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K30- Functional dyspepsia

Interventions

None listed

Sponsors

Sushrutha Ayurvedic Medical College and Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: I. Classical Symptoms of Amlapitta 1. Aruchi (anorexia) 2. Gurukoshthatva (heaviness in abdomen) 3. Gaurav (lethargy) 4. Vibandh (Constipation) 5. Shiroruja (Headache) 6. Utklesh (Nausea) 7. Tiktamlodgar (Acid eructation) 8. Klama (exhaustion) and 9. Hrid- Kanta Daha (heartburn) will be considered for the study and examined on the basis of Dosha Dushya etc with a help of a special proforma after having a written consent. II. Rome IV diagnostic criteria for Dyspepsia (Patients presenting with recurrent upper GI symptoms suggestive of dyspepsia for at least the past 6 months) One or more of the following: 1. Bothersome postprandial fullness 2. Bothersome early satiation 3. Bothersome epigastric pain 4. Bothersome epigastric burning AND III. Patients with any of the following features will be evaluated clinically for other diagnoses with dyspepsia and will be ruled out (No evidence of systemic metabolic structural disease that is likely to explain the symptoms) 1. Signs or symptoms of GI bleeding. 2. Unexplained iron deficiency anemia. 3. Unintentional weight loss. 4. Palpable abdominal mass or lymphadenopathy on exam. 5. Family history of gastric cancer and no recent upper endoscopy. 6. Dysphagia. 7. Persistent vomiting.

Exclusion criteria

Exclusion criteria: ? Age below 18 above 60 years ? Volunteers with evidence of malignancy ? Suffering from major Systemic diseases ? Metabolic diseases other than Dyspepsia ? Chronic diseases with long run of medications ? Pregnant ladies & lactating women ? Participants currently taking medications or supplements that may affect the present study ? Participants currently enrolled in any other clinical trials or having participated in any other clinical trial in the past 30 days. ? Participants with history or currently under substance abuse. ? Any other conditions which investigator things may jeopardize the study.

Design outcomes

Primary

MeasureTime frame
To assess analytical properties & evaluate the therapeutic effects of Amladhya Loham in managing symptoms of Amlapitta (Dyspepsia).Timepoint: 0 day and 31st day

Secondary

MeasureTime frame
1. To prepare Amladhya Loham 2. Evaluate the safety of Amladhya Loham 3. Analyze the changes in symptomatology & clinical parameters of Amlapitta (Dyspepsia) using Assessment Criteria for Subjective parameters 4. Assess the reduction in frequency & severity of Dyspepsia with GSRS questionnaire Timepoint: 0 day & 31st day

Countries

India

Contacts

Public ContactDr Abhishek Biswas

Sushrutha Ayurvedic Medical College and Hospital

punyargangadkar@gmail.com8088694522

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026