Clinical Study to Evaluate Efficacy and Safety of Dabur Ratnaprash Sugar Free Diabetic patients

Completed

• Conditions: Type 2 diabetes mellitus without complications,

• Registration Number: CTRI/2015/11/006390
• Lead Sponsor: Dabur India Limited

Brief Summary

This study is two Arm, Randomized, Open Labeled, Prospective, Multi-Centre, Clinical Study to Evaluate Efficacy and Safety of Dabur Ratnaprash Sugar Free (DRDC/2015/003) in Controlled Type II Diabetic patients. Study will be multicentric and type II diabetic subjects in age group of 18 to 70 years  would be randomized to either of the two groups i.e Group A –  one teaspoon of Dabur Ratnaprash Sugar free followed with a glass of milk without sugar twice daily for 90 days and Group B – a glass of milk without sugar twice daily for 90 days in 1:1 ratio.Both the groups will be advised to continue their regular diet/Exercise/Drug regimen as they were already taking. A glass of milk will be considered as 100-200 ml. Treatment period will be 90 days with total 8 visits including screening & randomization. Expected number of completers is planned to be 100 subjects. The study would include various assessment parameters including changes in glucose,energy,stamina, physical strength , stress, symptoms of Diabetes, micro-albuminuria, dose of OHAs, Physician’s Global evaluation for overall change on CGI-I Scale, clinically significant abnormal laboratory parameters,global assessment of overall safety of Dabur Ratnaprash Sugar free as per the physician & Subject

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-12
• Last Update Posted: 2019-11-02

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Subjects suffering from Type II Diabetes Mellitus for more than one year, and stabilized on either exercise/diet regimen or mono / poly drug oral anti-diabetic therapy.
• Subjects having HbA1c value below 8% at screening.
• Subjects having Fasting Plasma Glucose 90 -150 mg/dl (both inclusive) and postprandial glucose in the range of 110-180 mg/dl at screening.
• Subjects in the age group of 18 to 70 years, both inclusive.
• Subjects of female gender or non-pregnant, non-lactating females, .
• A urine pregnancy test is required for all female subjects of childbearing potential unless subject has had a hysterectomy, tubal ligation, or is > 2 years postmenopausal.
• Subjects willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form.

Exclusion Criteria

• Subjects on Insulin therapy.
• Known cases of Severe/Chronic hepatic or renal disease.
• Known subject of any active malignancy.
• Subjects giving history of significant cardiovascular event < 12 weeks prior to randomization.
• Subjects having known major complications of Diabetes like Ketoacidosis, Nephropathy, Neuropathy, Retinopathy, and Diabetic wounds.
• Subjects having known chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
• Known subjects of having active metabolic or gastrointestinal diseases that may interfere with nutrient absorption, metabolism, or excretion, excluding diabetes.
• Subjects using any other investigational drug within 1 month prior to recruitment 9.
• Known hypersensitivity to any of the ingredients used in study drug 10.
• Pregnant and Lactating females.
• Subjects currently participating in any other Clinical study 12.
• Any other condition due to which patients are deemed to be unsuitable by the investigator for reason(s) not specifically started in the exclusion criteria.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Assessment of changes in HbA1c % (Glycosylated Hemoglobin %) levels.	90 Days (3 Months)
2. Assessment of quality of life (QOL) on WHO QOL Questionnaire	90 Days (3 Months)

Secondary Outcome Measures

Name	Time	Method
To Assess changes in fasting & pp plasma glucose,energy level, stamina, physical strength , stress level, symptoms of Diabetes, micro-albuminuria, dose of OHAs, Physician’s Global evaluation for overall change on CGI-I Scale,clinically significant abnormal laboratory parameters, Global assessment of overall safety of Dabur Ratnaprash Sugar free as per the physician & Subject

Trial Locations

Locations (3)

Ayurved Seva Singhs Ayurved Mahavidyalaya; 🇮🇳 Nashik, MAHARASHTRA, India

D Y Patil College of Ayurveda; 🇮🇳 Mumbai, MAHARASHTRA, India

KVTR College of Ayurved, Boradi; 🇮🇳 Dhule, MAHARASHTRA, India

Ayurved Seva Singhs Ayurved Mahavidyalaya

🇮🇳Nashik, MAHARASHTRA, India

Dr Shishir Pandey

Principal investigator

9420830818

shishir.nsk@gmail.com