| CTRI Number |
CTRI/2024/07/070097 [Registered on: 05/07/2024] Trial Registered Prospectively |
| Last Modified On: |
26/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Clinical study to evaluate the add on effectiveness of sorghum samp and poly herbal tea in diabetes mellitus type II |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the add on effectiveness of sorghum samp (yavanala yusha) and poly herbal tea in the management of diabetes mellitus type II |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr K Samudrudu |
| Designation |
PhD Scholar |
| Affiliation |
SDM College of Ayurveda and Hospital Hassan |
| Address |
Department of swasthavritta and yoga
SDM College of Ayurveda and Hospital Hassan
B M Road, Thanniruhalla, Hassan,
Karnataka 573201, India.
Hassan
KARNATAKA
573201
India |
| Phone |
8310423646 |
| Fax |
|
| Email |
samudrudukage@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivakumar |
| Designation |
Associate Professor |
| Affiliation |
SDM College of Ayurveda and Hospital Hassan |
| Address |
Department of swasthavritta and yoga
SDM College of Ayurveda and Hospital Hassan
B M Road, Thanniruhalla, Hassan,
Karnataka 573201, India.
Hassan
KARNATAKA
573201
India |
| Phone |
9886259437 |
| Fax |
|
| Email |
drshivakumar@sdmcahhassan.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr K Samudrudu |
| Designation |
PhD Scholar |
| Affiliation |
SDM College of Ayurveda and Hospital Hassan |
| Address |
Department of swasthavritta and yoga
SDM College of Ayurveda and Hospital Hassan
B M Road, Thanniruhalla, Hassan,
Karnataka 573201, India.
Hassan
KARNATAKA
573201
India |
| Phone |
8310423646 |
| Fax |
|
| Email |
samudrudukage@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM College of Ayurveda and Hospital Hassan |
|
|
Primary Sponsor
|
| Name |
Dr K Samudrudu |
| Address |
Department of swasthavritta and yoga
SDM College of Ayurveda and Hospital Hassan
B M Road, Thanniruhalla, Hassan,
Karnataka 573201, India. |
| Type of Sponsor |
Other [Individual] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shivakumar |
SDM College of Ayurveda and Hospital Hassan |
OPD 6 Madhumeha OPD
SDM College of Ayurveda and Hospital Hassan
B M Road, Thanniruhalla, Hassan,
Karnataka 573201, India.
Hassan
KARNATAKA |
9886259437
drshivakumar@sdmcahhassan.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan |
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: DIABETES MELLITUS TYPE II, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: SORGHUM SAMP (YAVANALA YUSHA), Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 20(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: WARM WATER), Additional Information: YUSHA FORM | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: POLY HERBAL TEA, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: WARM WATER), Additional Information: INSTANT TEA FORM | | 3 | Comparator Arm (Non Ayurveda) | | - | ROUTINE DIET | PATIENT WILL BE ALLOWED TO FOLLOW REGULAR ANTI DIABETIC MEDICINES AND ROUTINE DIET |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects fulfilling at least one of the diagnostic criteria
2.Less than 2 years of diagnosis
3.Age: 20 – 60 Years
4.Irrespective of the gender, religion and socio economic status
5.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
P.C.O.D.
Thyroid Dysfunction
Carcinoma
Ischemic Heart Disease.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) FBS
2) PPBS
3) HbA1C
4) Triglycerides |
0th day, 30th day, 60th day and 90th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Weight in kg
BMI
Waist circumference in cm |
interval of 0,30,60,90 days |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
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)
|
01/01/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Sorghum Samp 200ml and Polyherbal tea 50 ml will be given once in morning at 7:30 am and at 7pm respectively as a part of the daily diet in the management of Diabetes Mellitus type II. A minimum of 250 subjects fulfilling inclusion criteria will be selected for the study after subjecting them to thorough clinical examination as per the Proforma prepared for the study irrespective of gender, religion and socio-economic status and assigned into following 2 groups by alternative allocation method (1&2) Group 1: 125 subjects who are on Anti diabetic drugs will be continued same dose for 3 months. Group 2: 125 subjects will be given Sorghum Samp in the morning and Poly Herbal Tea in the evening as a part of daily diet along with Anti diabetic drugs which the subject is already taking will be continued in same dose for 3 months. |