A clinical study of DIADROPSZ, an ayurvedic product in treatment of Type 2 Diabetes Melitus

Active, not recruiting

• Conditions: Type 2 diabetes mellitus without complications,

• Registration Number: CTRI/2017/03/008057
• Lead Sponsor: Clinfound Clinical Research Services PvtLtd

Brief Summary

Most of the othertreatment methods for diabetes mellitus regard it as a largely dietary disease.But Ayurveda here differs widely in its outlook. Ayurveda does not regarddiabetes mellitus as a disease that can be treated by mere medicine or by adietary regimen. The Ayurvedic treatment for diabetes mellitus is based on anentire change in the lifestyle of the person.The current study looks at the  efficacy of an Ayurveda combination in Diabetes Melittus.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-09
• Last Update Posted: 2018-11-21

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 1.Body mass index (BMI) below 40 kg/m².
• Group A 1.25 Drug naive or previously treated Type 2 DM or patients willing to shift to sole Ayurvedic treatment.
• 2.Hemoglobin A1c (HbA1c) ≥7.5% and ≤11% or 3.Fasting Plasma Glucose (FPG) ≥130 mg/dL Group B.
• 1.25 patients with Type 2 DM with Modern Pharmaceutical Medication having insufficient glucose control.
• 2.Insufficient glucose control defined as laboratory results that are within the values established by the study such as an Hemoglobin A1c (HbA1c) ≥7.5% and ≤11% or a Fasting Plasma Glucose (FPG) ≥130 mg/dL.

Exclusion Criteria

• 1.Type 1 diabetes.
• 2.Current need for Insulin treatment.
• 3.Complication of DM.
• 4.Patients with concurrent serious Hepatic Dysfunction (defined as AST and/or ALT > 3 times of the upper normal limit) or Renal Dysfunction (defined as S.
• creatinine > 1.6mg/dl), uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) or other concurrent severe disease.
• 5.Women who are pregnant or lactating 6.Smokers/Alcoholics and/or drug abusers 7.
• Patient with poorly controlled Hypertension 8.
• Patients with evidence of malignancy 9.
• Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Hemoglobin A1c (HbA1c) at Week 12 (End of study).	Baseline and Week 12 (End of study).

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in Fasting Plasma Glucose (FPG)	Baseline Day 10 Day 20 Day 30
Change from Baseline in 2-hr Post-Meal Glucose (PMG)	Baseline Day 10 Day 20 Day 30
Changes from Baseline in BMI	Baseline Day 10 Day 20 Day 30
Symptomatic changes assessed using Ayurvedic symptom questionnaire	Baseline Day 10 Day 20 Day 30

Trial Locations

Locations (1)

Nangelil Ayurveda Medical College; 🇮🇳 Ernakulam, KERALA, India

Nangelil Ayurveda Medical College

🇮🇳Ernakulam, KERALA, India

DrSarat K Babu

Principal investigator

09446413215

saratayur@gmail.com