CTRI/2019/05/019452 [Registered on: 30/05/2019] Trial Registered Prospectively
Last Modified On:
14/06/2020
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Ayurveda
Study Design
Randomized, Parallel Group Trial
Public Title of Study
Clinical study on Yesaka Liquid in diabetic patients
Scientific Title of Study
A Randomized, multi-center, Open labeled, Comparative, Prospective Clinical Study To Evaluate Efficacy and Safety of Yesaka Liquid as an Add-on therapy to Oral Hypoglycemic Agent (OHA) in Type 2 Diabetic Patients.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
YSK/DM/SHPL/2019, Version 1.0, 02nd Apr 2019
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Shishr Pande
Designation
Professor
Affiliation
Ayurved Seva Sanghs Ayurved Mahavidyalaya Ganeshwadi Panchvati Nashik Maharashtra
Address
Ayurved Sanshodhan Vibhag, OPD No 7A Ground Floor Ayurved Seva Sanghs Ayurved Mahavidyalaya Ganeshwadi Panchvati Nashik Maharashtra
Nashik MAHARASHTRA 422003 India
Phone
9420830818
Fax
Email
shishir.nsk@gmail.com
Details of Contact Person Scientific Query
Name
Dr Sanjay Tamoli
Designation
Director
Affiliation
Target Institute of Medical Education and Research
Address
Target Institute of Medical Education and Research
A Wing 402- A,B,C, Jaswanti Allied Business Center, Ramchandra Lane Extension, Kachpada, Malad west, Mumbai
Mumbai (Suburban) MAHARASHTRA 400064 India
Phone
9322522252
Fax
Email
targetinstitute@yahoo.com
Details of Contact Person Public Query
Name
Dr Sanjay Tamoli
Designation
Director
Affiliation
Target Institute of Medical Education and Research
Address
Target Institute of Medical Education and Research
A Wing 402- A,B,C, Jaswanti Allied Business Center, Ramchandra Lane Extension, Kachpada, Malad west, Mumbai
MAHARASHTRA 400064 India
Phone
9322522252
Fax
Email
targetinstitute@yahoo.com
Source of Monetary or Material Support
Simandhar Herbal Pvt. Ltd.
Unit No 8 Gyan Mandir Building,
Gyan Mandir Road, Dadar West, Mumbai 400028
Primary Sponsor
Name
Simandhar Herbal Pvt Ltd
Address
Unit No 8 Gyan Mandir Building, Gyan Mandir Road, Dadar West, Mumbai 400028
MAMs SS Ayurveda Mahavidyalaya and Sane Guruji Arogya Kendra
Department of Kayachikitsa OPD No. 2 Ground Floor MAMs SS Ayurveda Mahavidyalaya and Sane Guruji Arogya Kendra Malwadi Hadapsar Pune, Maharashtra 411028 Pune MAHARASHTRA
9850393788
amolhartalkar@gmail.com
Dr Pavan Kumar Godatwar
National Institute of Ayurveda
Department of Roganidana & Vikriti Vijnana,OPD No 7, Ground floor, National Institute of Ayurveda, Madhav Vilas palace, Jorawar Singh gate, Amer Road,Jaipur,Rajasthan-302002 Jaipur RAJASTHAN
9314502834
gpawankumar@rediffmail.com
Dr Shailesh Deshpande
Parul Ayurveda Hospital
Department of Kaychikitsa, OPD no 106, Ground Floor, Parul Ayurveda Hospital, Parul University, P.O.Limba, Tal. Wagholia, Dist, Vadodara, Gujrat 391760 Vadodara GUJARAT
9763104451
dr.shaileshd@gmail.com
Dr Shrinivas Acharya
S.D.M. College of Ayurveda
P.G. Department of Kayachikitsa and Manasaroga, Ground Floor, OPD No. 7 S.D.M. College of Ayurveda, Kuthpady Udupi Karnataka 574 118 Udupi KARNATAKA
9448353813
gsa.ayurved@gmail.com
Details of Ethics Committee
No of Ethics Committees= 5
Name of Committee
Approval Status
Institutional Ethics Clearance committee –Human, Sri Dharmasthala Manjunatheshwara College of Ayurveda
Submittted/Under Review
Institutional Ethics Committee National Institute of Ayurveda Madhav Vilas Palace, Amer Road, Jaipur
Submittted/Under Review
Institutional Ethics Committee on Human Research,(PIA-IECHR)
Submittted/Under Review
Institutional Ethics Committee, Ayurved seva sangh Ayurved Mahavidyalaya, Nashik
Approved
Institutional Review Board For Research, MAMs SS Ayurveda Mahavidyalaya & Sane Guruji Aarogya Kendra
Submittted/Under Review
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Ongoing OHA(s)
As per physicians advise
Intervention
Yesaka Liquid
contains Phyllanthus emblica, Terminalia chebula, Terminalia bellerica, Eugenia jambolana, Picorhiza kurroa, Swertia chirata, Tinospora cordifolia, Gymnema Sylvestere, Curcuma longa, Salacia chinesis, Melia azardirachta
Dosage and Treatment Duration: In addition to the on-going OHA(s), 20 ml twice daily orally on before meal with lukewarm water for 90 days.
Inclusion Criteria
Age From
20.00 Year(s)
Age To
70.00 Year(s)
Gender
Both
Details
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
ExclusionCriteria
Details
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
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Pharmacy-controlled Randomization
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
1. Changes in HbA1C (Glycosylated Hemoglobin) value between the groups (Pre and post)
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
Outcome
TimePoints
1. Monthly changes in BSL F and PP levels
2. Change in HOMA IR score
3. Change in fasting serum Insulin level
4. Monthly change in dose of OHAs
5. Monthly change in weight, BMI, waist circumference, Hip Circumference, waist: Hip ratio, BMR, Body fat percentage
6. Changes in clinical symptoms of Type 2 DM
7. Change in global assessment for overall change by the subject and investigator
8. Change in tolerability of study drugs
9. Change in Laboratory parameters and ECG.
Day -7, Day 0, Day 30, Day 60, Day 90
Target Sample Size
Total Sample Size="100" Sample Size from India="100" Final Enrollment numbers achieved (Total)= "0" Final Enrollment numbers achieved (India)="0"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
It is a randomized,
multi-center, open labeled, comparative, prospective clinical study to evaluate
efficacy and safety of Yesaka Liquid as an Add-on therapy to Oral Hypoglycemic
Agent (OHA) in Type 2 Diabetic Patients. The study will be conducted at five
sites in India. As per computer generated randomization list, subjects will receive
either on-going OHA(s)+ 20 ml twice daily orally on before meal with lukewarm
water or ongoing OHA(s) for 90 days. The primary objectives of the study will
be to evaluate change in HbA1C (Glycosylated Hemoglobin) value between the
groups (Pre and post) and monthly changes in WHOQOL over three months of the
study treatment between the groups. The secondary objectives of the study will
be to evaluate Monthly changes in fasting and postprandial plasma glucose
levels between the groups over three months of study treatment, change in HOMA
IR score between the two groups (Before and after treatment), change in fasting
serum Insulin level between the groups (Before and after treatment), monthly
change in dose of OHAs between the groups, monthly change in weight, BMI, waist
circumference, Hip Circumference, waist: Hip ratio, Basal Metabolic Rate (BMR),
Body fat percentage (Instrumental evaluation) between the groups, changes in
clinical symptoms of Type 2 DM i.e. Polydipsia, Polyphasia, Polyurea, &
Fatigue between the groups, change in global assessment for overall Change by
the subject at the end of 90 days of study treatment between the groups, change
in global assessment for overall Change by the investigator at the end of 90
days of study treatment between the groups, change in tolerability of study
drugs by assessing ADRs on study completion between the groups and change in
Laboratory parameters like Liver function tests (LFT), Renal function tests
(RFT), Lipid profile, complete blood count (CBC), ESR, Hb%, Urine Examination
and ECG on study completion between the groups on day 0, day 30, day 60, day
90.