Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1 Diagnosed Case of Type 2 Diabetes Mellitus (blood glucose level fasting more than 126mg per dl to less than 200 mg per dl Postprandial Blood glucose more than 200 mg per dl to less than 300 mg per dl HbA1C more than 6.5 percent to 8 percent) 2 Presence of gastrointestinal and dysbiosis symptoms suggestive of gut dysbiosis based on Dys R and Self Dysbiosis Severity Score (SDSS) In Dys R Scale maximum score is 14 (Score more than 8 Risk of dysbiosis and score less than or equal to 8 No risk of dysbiosis) Self-Dysbiosis Symptom Severity score Based on important symptoms of dysbiosis. Total number of questions is 15. Each question symptom may get value from 0 to 3 according to their intensity. Maximum number of total scores will be 45 and symptom severity classified as 1 to 15 Mild Dysbiosis 16 to 30 Moderate Dysbiosis 31 to 45 Severe Dysbiosis. Total score exceeding 30 will be considered for study. 3 Urine Indican test positive and or stool culture through MacConkey Agar Media and MRS Agar Media showing evidence of dysbiosis. 4 Participants willing to give consent for participating in the study. 5 Participants who can understand Bengali or Hindi or English language.
Exclusion criteria
Exclusion criteria: 1 Recent use (within 3 month) of antibiotics probiotics or prebiotics that could alter gut microbiota. 2 History of inflammatory bowel disease (IBD) irritable bowel syndrome (IBS) or chronic liver disease. (based on previous medical diagnosis or by red flag signs for example rectal bleeding weight loss fever). 3 Ongoing treatment with corticosteroids and immunosuppressants. 4 Alcohol or other substance abuse. 5 Pregnant and lactating mothers. 6 Unstable psychiatric illnesses.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in gastrointestinal and dysbiosis symptoms, assessed using the Self-Dysbiosis Severity Score (SDSS) and laboratory parameters (Urine Indican Test or/and Stool Culture through MacConkey Agar Media and MRS Agar Media).Timepoint: Baseline, 3rd month and 6th months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in fasting blood glucose level in individual with T2DM while observing changes in dysbiosis during homoeopathic treatment.Timepoint: Baseline, 3rd month and 6th months. | — |
Countries
India
Contacts
National Institute Of Homoeopathy