Effect of homoeopathic intervention in Prediabetes.

Phase 3

• Conditions: Health Condition 1: null- Pre-diabetes

• Registration Number: CTRI/2016/09/007318
• Lead Sponsor: Central Council for Research in Homoeopathy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 397

Inclusion Criteria

•Indian diabetic risk score(IDRS) more than equal to 60

•Adults above 35 years with impaired glucose regulation (2hrs oral glucose tolerance test with 75 g glucose load more than equal to 140 mg per dL and ,less than 200 mg per dl, fasting plasma glucose concentration of 6.1mmol/L ( >110 mg/dL) or greater but less than 7.0 mmol per L (126mg per dL) as recommended by WHO (1999).

•Patients who are negative on Glutamic acid Decarboxylase (GAD) antibodies and insulin antibodies

•Written informed consent

Exclusion Criteria

•Self reported HIV positivity

•Self reported cardiovascular disease such as bundle block, uncontrolled hypertension (SBP >180 mmHg or DBP >105 mmHg on treatment). Milder degrees of hypertension would prompt referral to primary care provider for treatment but would not exclude.

•Stroke or transient ischemic attack in the past 6 months

•Recent or significant abdominal surgery (e.g. gastrectomy) during last six months.

•Unable or unwilling to give informed consent and comply with study protocol

•Likely to move away from participating clinics in next 01 year

•Pregnancy and Lactating mother

•Major psychiatric disorder which would impede conduct of the study

•Excessive alcohol intake, either acute or chronic. Those patients who are taking 60 ml in case males and 30 ml in case of females per day

•Diabetes at baseline evaluation evidenced by any of the following:

ï?­Fasting blood glucose 126 mg/dL [7.0 mmol/L]

ï?­2-hour blood glucose 200 mg/dL [11.1 mmol/L] based on 75 gm OGTT

ï?­Diabetes diagnosed by a physician and confirmed by other clinical data (e.g. documentation of a fasting

ï?­Plasma glucose 126 mg/dL [7.0 mmol/L] or a positive OGTT

•Ever used hypoglycemic medication (oral agents or insulin; except during GDM) i.e. in the last six months any medication which would affect the blood glucose metabolism will be excluded (corticosteroids, oral agents, insulin).

•Any systemic illness to be excluded (LFT, KFT).

•TSH test to exclude sub clinical and clinical hypothyroidism at baseline.

•Self reported thyroid disease, sub optimally treated.

•Patientsâ?? positive for GAD and insulin antibodies will be excluded.

Study & Design

• Study Type: Interventional
• Study Design: Not specified