| CTRI Number |
CTRI/2024/07/070882 [Registered on: 19/07/2024] Trial Registered Prospectively |
| Last Modified On: |
18/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness of Poly Herbal Tea in the management of Diabetes Mellitus type 2. |
|
Scientific Title of Study
|
Comparative clinical study to evaluate the add on effectiveness of poly herbal tea in the management Of Diabetes Mellitus Type 2 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sathwik M S |
| Designation |
PhD Scholar |
| Affiliation |
SDM College Ayurveda and hospital, Hasaana |
| Address |
Department of Swasthavritta and Yoga.
SDM College of Ayurveda and Hospital, Hassan
Department of Swasthavritta and Yoga.
OPD NO 10
SDM College of Ayurveda and Hospital, Hassan
Hassan
KARNATAKA
Dr Sathwik M S
India |
| Phone |
9538141275 |
| Fax |
|
| Email |
drsathwikms@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivakumar |
| Designation |
Associate professor |
| Affiliation |
SDM College of Ayurveda and Hospital, Hassan, 573201 |
| Address |
Associate professor,
Department of Swasthavritta and Yoga.
SDM College of Ayurveda and Hospital, Hassan
Department of Swasthavritta and Yoga.
OPD NO 10
SDM College of Ayurveda and Hospital, Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
9886259437 |
| Fax |
|
| Email |
drshiva.k@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sathwik M S |
| Designation |
PhD Scholar |
| Affiliation |
SDM College of Ayurveda and Hospital, Hassan, 573201 |
| Address |
Department of Swasthavritta and Yoga.
SDM College of Ayurveda and Hospital, Hassan
Departmentof Swasthavritta and Yoga.
OPD NO 10
SDM College of Ayurveda and Hospital, Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
9538141275 |
| Fax |
|
| Email |
drsathwikms@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM College of ayurveda and Hospital, Hassan, India, pin;573201 |
|
|
Primary Sponsor
|
| Name |
Dr Sathwik M S |
| Address |
phd scholar,Department of Swasthavritta and Yoga, Sri Darmasthala Manjunatheswara college of Ayurveda and Hospital, Hassan, 573201, India |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sathwik M S |
Sidramappa Danigond Memorial Trusts Ayurvedic Medical College and Hospital, Terdal |
Department of Swasthavritta and Yoga, Sidramappa Danigond Ayurvedic Medical College,
and HospitalCentre, Terdal- 587315, Karnataka
Bagalkot
KARNATAKA |
9538141275
drsathwikms@gmail.com |
| Dr Sathwik M S |
Sri Darmasthala Manjunatheswara College of Ayurveda and Hospital |
OPD no-10
Department of Swasthavritta and Yoga, Sri Darmasthala Manjunatheswara college of Ayurveda and Hospital,BM Road, Hassan-573201, Karnataka
Hassan
KARNATAKA |
9538141275
drsathwikms@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Communication of Decision of Institutional Ethical Committee(IEC) |
Approved |
| Institutional Ethical Committee For Research On Human Subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E11||Type 2 diabetes mellitus. Ayurveda Condition: PRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: karavellakadi herbal tea, Reference: charaka, Route: Oral, Dosage Form: Dravaka, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: -herbal tea | | 2 | Comparator Arm (Non Ayurveda) | | - | patient on Antidiabetic medication | 100 subjects who are on Antidiabetic drugs will be continue same dose. if new case is coming under study will be administered with ayurvedic anti diabetic drugs for 3 months |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects fulfilling at least one of the diagnostic criteria
2.Age: 30 year and above
3.subject Irrespective of the gender, religion and socio-economic status
4.subject Willing to give written consent
|
|
| ExclusionCriteria |
| Details |
1. Insulin dependent subjects.
2.Known case of Diabetic nephropathy
3.Known case of Ketoacidosis
4.Known case of Cerebrovascular diseases
5.Women in Pregnancy/lactation
6. Subjects with other systemic disorders such as
a) P.C.O.D
b) Thyroid Dysfunction.
c) C.A
d) Ischemic Heart Disease.
7.Known case of Mentally ill
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of Herbal Tea in the symptoms of Diabetes Mellitus Type 2 |
Effect of Herbal Tea in symptoms of Diabetes Mellitus type 2, after 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Compare effect of Poly Herbal Tea in symptoms of Diabetes Mellitus Type 2 in future |
Compare effect of Poly Herbal Tea in symptoms of Diabetes Mellitus Type 2 after 3 months |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/11/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="4"
Months="1"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A minimum of 200 subjects fulfilling inclusion criteria will be selected for the study after subjecting them through clinical examination as per the proforma prepared for the study irrespective of gender, religion and socioeconomic status and assigned into following 2 groups by alternative allocation method (1&2) group 1: 100 subjects who are on Antidiabetic drugs will be continued same dose. if new case is coming under study will be administered with ayurvedic anti diabetic drugs for 3 months. group 2: 100 subjects will be given karavellakadi herbal tea as part of daily diet twice a day along with antidiabetic drugs which the subject already taking will be continued in same dose. The stored herbal ingredients will be packed in to tea bags separately, each tea bag weighing 6g, customized tea bag boxes will be made to keep tea bags according to need and distribution. preparation of herbal tea ( by the subjects under study) : 6g of herbal tea bag is dipped in 50 ml of hot water for 5 minutes (both morning and evening) 7am and 7pm
Data will be collected using case report form designed by incorporatingall aspects ( Ayurvda and modern medicine) for the study. this collected data will be tabulated and analyzed using SPSS version 20 and analyzed using following statistical test
|