Clinical study on Yesaka Liquid in diabetic patients

Phase 2/3

Completed

• Conditions: Type 2 diabetes mellitus without complications,

• Registration Number: CTRI/2019/05/019452
• Lead Sponsor: Simandhar Herbal Pvt Ltd

Brief Summary

It is a randomized,multi-center, open labeled, comparative, prospective clinical study to evaluateefficacy and safety of Yesaka Liquid as an Add-on therapy to Oral HypoglycemicAgent (OHA) in Type 2 Diabetic Patients. The study will be conducted at fivesites in India. As per computer generated randomization list, subjects will receiveeither on-going OHA(s)+ 20 ml twice daily orally on before meal with lukewarmwater or ongoing OHA(s) for 90 days. The primary objectives of the study willbe to evaluate change in HbA1C (Glycosylated Hemoglobin) value between thegroups (Pre and post) and monthly changes in WHOQOL over three months of thestudy treatment between the groups. The secondary objectives of the study willbe to evaluate Monthly changes in fasting and postprandial plasma glucoselevels between the groups over three months of study treatment, change in HOMAIR score between the two groups (Before and after treatment), change in fastingserum Insulin level between the groups (Before and after treatment), monthlychange in dose of OHAs between the groups, monthly change in weight, BMI, waistcircumference, Hip Circumference, waist: Hip ratio, Basal Metabolic Rate (BMR),Body fat percentage (Instrumental evaluation) between the groups, changes inclinical symptoms of Type 2 DM i.e. Polydipsia, Polyphasia, Polyurea, &Fatigue between the groups, change in global assessment for overall Change bythe subject at the end of 90 days of study treatment between the groups, changein global assessment for overall Change by the investigator at the end of 90days of study treatment between the groups, change in tolerability of studydrugs by assessing ADRs on study completion between the groups and change inLaboratory parameters like Liver function tests (LFT), Renal function tests(RFT), Lipid profile, complete blood count (CBC), ESR, Hb%, Urine Examinationand ECG on study completion between the groups on day 0, day 30, day 60, day90.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-06
• Last Update Posted: 2020-06-14

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 1.Subjects suffering from Type 2 Diabetes Mellitus for more than one year, and stabilized on mono/ polydrug anti-diabetic therapy for at least last 3 months.
• 2.Subjects having HbA1C value 7-11% (both inclusive) at screening.
• 3.Subjects having Fasting Plasma Glucose between 126 -252 mg/dl (both inclusive) at screening.
• 4.Subject’s ECG not demonstrating any signs of uncontrolled arrhythmia / acute ischemia and X- ray chest not showing any active lesion of tuberculosis.
• 5.A urine pregnancy test is required for all female subjects unless subject has had a hysterectomy, tubal ligation, or is > 2 years post menopause.
• 6.Subjects willing to follow the procedures as per the study protocol and voluntarily signing informed consent form.

Exclusion Criteria

• 1.Subjects on insulin therapy.
• 2.Subjects suffering from type-1 DM or types of Diabetes mellitus other than Type-2 3.Subjects with known history of chronic hepatic or renal disease.
• 4.Subjects with known history of active malignancy.
• 5.Subjects with known history of significant cardiovascular event 12 weeks prior to randomization.
• 6.Subjects with known history of major complications of Diabetes like Ketoacidosis, Nephropathy, Neuropathy, Retinopathy, and Diabetic wounds.
• 7.Subjects with known history of chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
• 8.Subjects with known history of active metabolic or gastrointestinal diseases that may interfere with nutrient absorption, metabolism, or excretion, excluding diabetes.
• 9.History of Use of any other investigational drug within 1 month prior to randomization 10.Known history of hypersensitivity to ingredients used in study drug 11.Pregnant and Lactating females.
• 12.Any other conditions which in the opinion of investigator will place the subject at risk or will influence the conduct of study or interpretation of results.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Changes in HbA1C (Glycosylated Hemoglobin) value between the groups (Pre and post)	Day -7, Day 0, Day 30, Day 60, Day 90
2.Monthly changes in WHOQOL over three months of the study treatment between the groups	Day -7, Day 0, Day 30, Day 60, Day 90

Secondary Outcome Measures

Name	Time	Method
1.Monthly changes in BSL F and PP levels	2.Change in HOMA IR score

Trial Locations

Locations (5)

Ayurved Seva Sangh’s Ayurved Mahavidyalaya; 🇮🇳 Nashik, MAHARASHTRA, India

MAMs SS Ayurveda Mahavidyalaya and Sane Guruji Arogya Kendra; 🇮🇳 Pune, MAHARASHTRA, India

National Institute of Ayurveda; 🇮🇳 Jaipur, RAJASTHAN, India

Parul Ayurveda Hospital; 🇮🇳 Vadodara, GUJARAT, India

S.D.M. College of Ayurveda; 🇮🇳 Udupi, KARNATAKA, India

Ayurved Seva Sangh’s Ayurved Mahavidyalaya

🇮🇳Nashik, MAHARASHTRA, India

Dr Shishr Pande

Principal investigator

9420830818

shishir.nsk@gmail.com