| CTRI Number |
CTRI/2022/04/042122 [Registered on: 25/04/2022] Trial Registered Prospectively |
| Last Modified On: |
19/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Clinical study on Yesaka Plus Tablets in Type 2 Diabetic Patients |
|
Scientific Title of Study
|
A Double blind, Multi-center, Randomized, Prospective, Interventional, Placebo controlled, Clinical study to Evaluate Efficacy and Safety of Yesaka Plus Tablets in patients diagnosed with Type 2 Diabetes mellitus |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| YSK/DM/SHPL/2022, Version 1.0, 26th February 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vyankatesh Shivane |
| Designation |
Consulting Diabetologist and Endocrinologist |
| Affiliation |
Sadhana Diabesity Clinic |
| Address |
Sadhana Diabesity Clinic First Floor, B-6 New Bhavana Building, SVS Rd, Above Rajashree Productions & Marshalls Showroom,
Prabhadevi, Mumbai, Maharashtra
Mumbai
MAHARASHTRA
400025
India |
| Phone |
9820084780 |
| Fax |
|
| Email |
drvkshivane@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research Pvt. Ltd. |
| Address |
Target Institute of Medical Education and Research Pvt. Ltd. Fourth Floor,
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 Pvt. Ltd. |
| Address |
Target Institute of Medical Education and Research Pvt. Ltd. Fourth Floor,
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 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shishr Pande |
Ayurved Seva Sangh’s Ayurved Mahavidyalaya |
Ayurved Sanshodhan Vibhag
OPD No 7A, Ground Floor, Ayurved Seva Sangh’s Ayurved Mahavidyalaya, Ganeshwadi, Panchvati, Nashik, Maharashtra – 422003
Nashik
MAHARASHTRA |
9420830818
shishir.nsk@gmail.com |
| Dr Deepa Patil |
JSS Ayurveda Medical College and Hospital |
Department of Kayachikitsa, OPD No. 1, Ground Floor, JSS Ayurveda Medical College and Hospital, Lalitharipura Road, Allanahalli, Mysore, Karnataka- 570028
Mysore
KARNATAKA |
9886485005
deepsmysore@gmail.com |
| Dr Shripat Kore |
Sane Guruji Arogya Kendra |
Department of Kayachikitsa, Special OPD No. 2, 2nd floor, Sane Guruji Arogya Kendra, Malwadi Hadapsar, Pune-28
Pune
MAHARASHTRA |
8999076147
dkshripad@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Ayurved seva Sangh’s Ayurved Mahavidyalaya, Nashik |
Approved |
| Institutional Ethics Committee, JSS Ayurveda Medical College and Hospital, Mysore |
Approved |
| Institutional Ethics Committee, Khemdas Ayurved College and Hospital |
Approved |
| Institutional Ethics Committee, KVTR Ayurved College and Hospital, Boradi |
Approved |
| Institutional Review Board for Research, MAMs SS Ayurveda Mahavidyalaya & Sane Guruji Aarogya Kendra |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: PRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Yesaka Plus Tablet contains, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 1200(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: water), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Placebo Tablet | Subjects will be asked to consume Placebo tablet in a dose of 2 tablets twice daily orally after meals with water for 90 days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients diagnosed with type 2 diabetes mellitus for not more than one year and those are not on any oral hypoglycemic agent/insulin (regular basis).
2. Patients having HbA1C value between 6.5-8.5% (both inclusive) at screening.
3. Patients having Fasting Plasma Glucose between 126 -250 mg/dl (both inclusive) at screening.
4. Patients having postprandial glucose not more than 350 mg/dl at screening
5. Patient’s ECG does not demonstrate any signs of uncontrolled arrhythmia / acute ischemia.
6. A negative urine pregnancy test for all female patients unless patient has had a hysterectomy, tubal ligation, or is > 2 years post menopause.
7. Patients willing to follow the procedures as per the study protocol and voluntarily signing informed consent form
|
|
| ExclusionCriteria |
| Details |
1. Patients already on regular OHAs or on insulin therapy.
2. Patients suffering from type-1 DM or types of Diabetes mellitus other than Type-2
3. Patients with known history of chronic hepatic or renal disease.
4. Patients with known history of malignancy.
5. Patients with known history of significant cardiovascular event 12 weeks prior to randomization.
6. Patients with known history of major complications of Diabetes like Ketoacidosis, Nephropathy, Neuropathy, Retinopathy, and Diabetic wounds.
7. Patients with known history of chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
8. Patients 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 Patients 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
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Change in HbA1C% (Glycosylated Hemoglobin) over a period of three months and between the groups
2. Change in FBS and PPBS on monthly basis over 90 days (Before and after treatment) and between the groups
|
Day -7, Day 0, Day 30, Day 60, Day 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Change in Fasting Serum Insulin.
2. Change in HOMA-IR score
3. Change in clinical symptoms of Type 2 DM
4. Difference in the number of rescue medication required by each group
5. Monthly change in weight and BMI.
6. Change in quality of life assessed on QOLID.
7. Change in global assessment for overall change by subject and investigator.
8. Tolerability of study drugs
9. Change in Laboratory parameters
|
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" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
29/04/2022 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It
is a double blind, multi-center, randomized, prospective, interventional, placebo
controlled, clinical study to evaluate efficacy and safety of Yesaka Plus
Tablets in patients diagnosed with Type 2 Diabetes mellitus. The study will be
conducted at 4 centers in India. As
per computer generated randomization list, subjects will be either randomized
to Yesaka Plus Tablets group or Placebo Tablet group in 1:1 ratio. Subjects
will be asked to consume given medication in a dose of 2 tablets twice daily orally
after meals with water for 90 days. The primary objectives of the study will be
to assess change in HbA1C% (Glycosylated Hemoglobin) over a period of three
months and between the groups and change in FBS and PPBS on monthly basis over
90 days (Before and after treatment) and between the groups. The secondary
objectives will be to assess change in Fasting Serum Insulin, change in HOMA-IR
score, change in clinical symptoms of Type 2 DM, difference in the number of
rescue medication required by each group, monthly change in weight and BMI, change in quality of life assessed on QOLID, change
in global assessment for overall change by subject and investigator, tolerability
of study drugs and change in Laboratory parameters on day 0, day 30, day 60, day 90. |