Study the effect of haridra powder on blood sugar in pre diabetic patients

A Randomised Open LabelControlled prospective Phase II clinical study of Haridra Churna on Glycemic control in Pre-Diabetic subjects

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/09/015795

Enrollment

146

Registered

2018-09-20

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-01

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

Conditions

None listed

Interventions

Intervention1: Unprocessed Haridra Churna: 5 gm twice daily before meals with lukewarm water for 24 weeks Control Intervention1: Processed Haridra Churna: 5 gm twice daily before meals with lukewarm w

Eligibility

Inclusion criteria

Inclusion criteria: Pre-diabetic subjects with HbA1c of 6 to 6.4 Subjects who agree to participate in the study and submit a written informed consent form

Exclusion criteria

Exclusion criteria: 1. Known Cases of DM, both type I and II. 2. Past history of gestational diabetes 3. Subjects on ß-blockers, thiazide diuretics, corticosteroids, HRT. 4. Uncontrolled Hypertensive subjects(with or without medication > 140/90 mmHg) 5. Any unstable Heart disease 6. Patients with concurrent Hepatic Dysfunction (defined as AST and/or ALT > 2 times of the upper normal limit) or Renal Dysfunction (defined as S. creatinine > greater than ULL), uncontrolled Pulmonary Dysfunction (asthmatic and COPD subjects). 7. Pregnant / Lactating women. 8. Alcoholics and/or drug abusers 9. Patients with evidence of malignancy 10. Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuroendocrinal disorders, etc.) 11. Patients who have completed participation in any other clinical trial during the past six (06) months. 12. Any other condition which the Investigator thinks may jeopardize the study.

Design outcomes

Primary

Measure	Time frame
Change in Glycosylated Hemoglobin (HbA1c)Timepoint: from baseline at 12 weeks and 24 weeks.	—

Secondary

Measure	Time frame
1. Change in Fasting blood sugar (min 8 hrs after dinner) 2. Change in Post prandial blood sugar (2 hours after breakfast) 3. Change in Plasma Insulin 4. Change in HOMA IR 5. Change in Lipid profile 6. Change in BMI and waist circumference 7. Change in Symptoms - Diabetes Symptoms Questionnaire (DSQ) 8. Change in SF-36 (RAND) Health Survey Score 9. Any SAE /ADR or change in laboratory parametersTimepoint: from baseline and at 12 and 24 weeks	—

Measure

Time frame

1. Change in Fasting blood sugar (min 8 hrs after dinner) 2. Change in Post prandial blood sugar (2 hours after breakfast) 3. Change in Plasma Insulin 4. Change in HOMA IR 5. Change in Lipid profile 6. Change in BMI and waist circumference 7. Change in Symptoms - Diabetes Symptoms Questionnaire (DSQ) 8. Change in SF-36 (RAND) Health Survey Score 9. Any SAE /ADR or change in laboratory parametersTimepoint: from baseline and at 12 and 24 weeks

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Countries

India

Contacts

Public ContactShishir Purushottam Pande

Ayurved Seva Sanghs Ayurved Mahavidyalaya Nashik

shishir.nsk@gmail.com2513112

Outcome results