| CTRI Number |
CTRI/2024/04/065521 [Registered on: 10/04/2024] Trial Registered Prospectively |
| Last Modified On: |
28/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Ayurvedic and allopathic management along with diet and yoga in uncontrolled type 2 diabetes mellitus |
|
Scientific Title of Study
|
Efficacy of Integrated Ayurveda Protocol in Inadequately Controlled Type 2 Diabetes Mellitus A Randomized Controlled Clinical Trial |
| 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 Asha |
| Designation |
PG Scholar |
| Affiliation |
KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi Karnataka |
| Address |
Dept of Kayachikitsa KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur, Belagavi, Karnataka
Belgaum
KARNATAKA
590003
India |
| Phone |
8607059548 |
| Fax |
|
| Email |
sangwanfire12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suketha Kumari |
| Designation |
Reader |
| Affiliation |
KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi Karnataka |
| Address |
Dept of Kayachikitsa KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi Karnataka
Belgaum
KARNATAKA
590003
India |
| Phone |
9483637757 |
| Fax |
|
| Email |
sukethashetty411@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suketha Kumari |
| Designation |
Reader |
| Affiliation |
KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi Karnataka |
| Address |
Dept of Kayachikitsa KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi Karnataka
Belgaum
KARNATAKA
590003
India |
| Phone |
9483637757 |
| Fax |
|
| Email |
sukethashetty411@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Shri BMK Ayurveda Hospital Shahapur Belagavi Karnataka OPD No 6 OPD No 3 |
|
|
Primary Sponsor
|
| Name |
Dr Asha |
| Address |
KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi Karnataka |
| Type of Sponsor |
Other [Self] |
|
|
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 ASHA |
KLE Shri BMK Ayurveda Hospital and research centre Shahpur Belagavi |
KAHERs Shri BMK
Ayurveda Hospital and
research centre
Shahpur Belagavi Dept
of Kayachikitsa OPD no
6 OPD no 3
Belgaum
KARNATAKA
Belgaum
KARNATAKA |
8607059548
sangwanfire12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for research on human subjects Shri BMK Ayurveda Mahavidyalaya and Hospital Shahapur Belagavi 590003 |
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 | Comparator Arm (Non Ayurveda) | | - | Standard antidiabetic care | Ongoing antidiabetic oral
medications (for more than or equal to 90 days
prior to intervention)
Standard Dietary and
lifestyle protocol
| | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Nishakatakadi kashaya gulika, Reference: Sahasrayogam, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: lukewarm water), Additional Information: 1 Nishakatakadi Kashaya Gulika (2gm/day) 2-tab BD with lukewarm water before breakfast and dinner 2 Ayurveda diet intervention (Annexure-1) 3 Yoga Sculpt (modified yoga protocol) (Annexure-2)
Annexure-1 Diet chart for diabetes(1200Kcal plus or minus 50Kcal) per day (Protein 45.5gm per day,CHO 177gm,Fat 31.7gm per day of ayurevda diet
Annexure 2- modified yoga protocol
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1 Diagnosed T2DM with chronicity of equal to or less
than one year duration
2 Age group between 18 to 50 years
3 Glycosylated hemoglobin (HbA1c) between 7.0
percent to 10.5 percent
4 Subject who submits written informed consent |
|
| ExclusionCriteria |
| Details |
1 Subjects with uncontrolled hypertension (with BP
more than or equal to 140/90 mmHg)
2 Subjects with established diagnosis of CAD or
any other clinically significant cardiovascular
disease
3 Subjects with established cases of
cerebrovascular accidents such as stroke etc
4 Subjects with any complications of Type 2
Diabetes Mellitus such as retinopathy,
neuropathy, nephropathy etc
5 Pregnant and lactating women
6 Subjects not fit for Yoga performance |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| HbA1c |
0th 90th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| weight waist circumference FBS PPBS Triglycerides Triglyceride glucose index |
weight waist circumference FBS PPBS Urine sugar BMI (Baseline 30th 60th 90th day)
Triglyceride glucose index Triglycerides and QoL-SF36(baseline and 90th day)
|
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 3 |
|
Date of First Enrollment (India)
|
01/05/2024 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Diabetes is a chronic, metabolic disease characterized by elevated levels of blood
glucose, which leads overtime to serious damage to the heart, blood vessels, eyes,
kidneys and nerves. Diabetes affects an estimated 537 million adults worldwide
between the age of 20 to 79 (10.5% of all adults in this age range). By 2030, 643
million people will have diabetes globally, increasing to 783 million by 2045. Type
2 Diabetes mellitus(T2DM) accounts for more than 90 – 95% of all patients with
diabetes. In epidemiological surveys and as per the American Diabetes Association
(ADA), Inadequately controlled T2DM is measured as a glycated hemoglobin level of
>7%. An anti-diabetic drug’s therapeutic strategy should be able to stop the advancement of
diabetes complications as well as glycaemic control. [v] Because they are successful at
lowering blood glucose levels and have the fewest adverse effects, alternative
medicines for diabetes have recently gained popularity. If this all-encompassing approach is proven to be successful, it might be safer and better
tolerated. Ayurvedic medicine’s importance would also be highlighted by the absence
of supporting data, which could spark the start of additional randomized controlled
trials. The risk of macrovascular and microvascular problems in T2DM is reduced by
glycemic management. Pharmacological treatment and a change in lifestyle are
required for good glycemic control to be achieved and maintained. Pharmacological
treatment of T2DM has several drawbacks because it can cause hypoglycemia,
vitamin B12 deficiency, increased cardiovascular risk, etc. Yoga, Panchakarma
2
therapies, and Ayurvedic food and treatment will all be incorporated into the treatment
plan to promote adequate glycemic control and slow the development of problems. Thus, the need of the hour is to study the efficacy of Integrated Ayurveda protocol in
comparison to Standard protocol in T2DM. |