Health Condition 1: K929- Disease of digestive system, unspecified
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of either sex aged between 18 to 60 years. 2. Patient diagnosed with Ama-Ajirna (as per Ayurvedic classics) having the following symptoms/signs I. à¥?à¥?रà¥?ता(Heaviness of whole body/ abdomen), II. à¤?दà¥?à¤?ारशà¥?à¤?यथाà¤à¥?à¤?à¥?तमविदà¤?à¥?धà¤?(belching /snoitatcure just after meal), III. à¤?तà¥?à¤?à¥?लà¥?द(Nausea), IV. à¤?णà¥?डशà¥?फ(Swelling of the cheek), V. à¤?विà¤?à¥? à¤?शà¥?फ(Edema of the periorbital region), VI. सà¥?वादà¥?वासà¥?यता(sweet taste in mouth) 3. Willing and able to participate for 4 weeks &Subject should be able to provide a written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients suffering with other type of Ajirna viz. Vishatbdhajirna, Vidagdhajirna, Rasasheshajirna, Dinapakiajirna, Prakrutajirna 2. Subject with Red alarm features (unintentional weight loss, persistent vomiting, dysphagia, hematemesis, melena, fever, or jaundice) 3. Subject with known history of serious gastrointestinal disease (including peptic ulcers, malignancy, esophageal dysmotility, a previous endoscopic or radiological diagnosis of GERD and Barrettâ??s esophagus) 4. Patients with (Known cases of) Hypertension ( > 130/80mmHg). 5. Concomitant serious disease of vital organs such as the liver, kidney, heart or lungs. 6. Women who are pregnant, lactating, or planning to conceive. 7. Patients on prolonged (>=6 weeks) medication with corticosteroids, antidepressants, anticholinergics, etc. or any other drugs that may have an influence on the outcome of the study. 8. History of hypersensitivity to any of the trial drugs or their ingredients. 9. Patients who are judged by the investigators to be unsuitable to participate in the clinical trial (diagnosed psychotic illnesses, substance dependence or alcoholism) 10. Any other condition which the Investigator thinks may jeopardize the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Changes in symptoms of Amajirna à¥?à¥?रà¥?ता(Heaviness of whole body/ abdomen) à¤?दà¥?à¤?ारशà¥?à¤?यथाà¤à¥?à¤?à¥?तमविदà¤?à¥?धà¤?(belching /snoitatcure just after meal) à¤?तà¥?à¤?à¥?लà¥?द(Nausea) à¤?णà¥?डशà¥?फ(Swelling of the cheek) à¤?विà¤?à¥? à¤?शà¥?फ(Edema of the periorbital region) सà¥?वादà¥?वासà¥?यता(sweet taste in mouth) 2. Satisfactory therapeutic responseTimepoint: 1. baseline, 3rd Day, 7th days, 14th Day 2. within two week after completion of study medication | — |
Secondary
| Measure | Time frame |
|---|---|
| a. Psychological Assessment by Perceived Stress Scale(PSS) b. Agni assessment through Questionarries preparied by CCRAS. c. Disease relapse rate after treatment successTimepoint: a & b. baseline, 3rd Day, 7th days, 14th Day and 28th Day c. after 2 weeks of post treatment period | — |
Countries
India
Contacts
National AYurveda Research Institute, Cheruthuruthy, CCRAS