| CTRI Number |
CTRI/2025/07/091098 [Registered on: 17/07/2025] Trial Registered Prospectively |
| Last Modified On: |
16/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To check the difference in Blood Sugar Level and HbA1c after following modified Diet and Lifestyle |
|
Scientific Title of Study
|
SINGLE ARM CLINICAL STUDY TO ASSES THE EFFECTS OF DIETARY AND LIFESTYLE MODIFICATIONS IN
PRAMEHA (DIABETES MELLITUS TYPE II) PATIENTS WITH SPECIAL REFERENCE TO
BLOOD SUGAR LEVEL AND HbA1c
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rushabh Sureshchand Mandlecha |
| Designation |
MD Scholar of Rognidan evum Vikruti Vigyan |
| Affiliation |
LRP Ayurvedic Medical College, Islampur |
| Address |
LRP Ayurvedic Medical College and Hospital, Post Graduate Institute and Research Center Islampur
Department of Rognidan evum Vikruti Vigyan, LRP Ayurvrdic Medical College and Hospital, Post Graduate Institute and Research Center Islampur
Sangli
MAHARASHTRA
415409
India |
| Phone |
9049726543 |
| Fax |
|
| Email |
rushabhmandlecha1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhimanyu Patil |
| Designation |
Guide |
| Affiliation |
|
| Address |
Room No. 1, Department of Rognidan evum Vikruti Vigyan, LRP Ayurvedic Medical College and Hospital, Post Graduate Institute and Research Center Islampur
Sangli
MAHARASHTRA
415409
India |
| Phone |
9960538603 |
| Fax |
|
| Email |
manyupatil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhimanyu Patil |
| Designation |
Guide |
| Affiliation |
|
| Address |
Room No. 1, Department of Rognidan evum Vikruti Vigyan, LRP Ayurvedic Medical College and Hospital, Post Graduate Institute and Research Center Islampur
Sangli
MAHARASHTRA
415409
India |
| Phone |
9960538603 |
| Fax |
|
| Email |
manyupatil@gmail.com |
|
|
Source of Monetary or Material Support
|
| LRP Ayurvedic Medical College and Hospital, Post Graduate Institute and Research Center Islampur, Tq Walwa, Dist Sangli, State Maharashtra, Country India Pin Code 415409 |
|
|
Primary Sponsor
|
| Name |
Dr Rushabh Sureshchand Mandlecha |
| Address |
LRP Ayurvedic Medical College and Hospital, Post Graduate Institute and Research Center Islampur |
| 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 Rushabh Sureshchand Mandlecha |
LRP Ayurvedic Hospital, Islampur |
Room No. 1, Department of Rognidan evum Vikruti Vigyan, LRP Ayurvedic Medical College and Hospital, Post Graduate Institute and Research Center Islampur
Sangli
MAHARASHTRA |
9049726543
rushabhmandlecha1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| LRPAMC - Institutional Ethics Committee |
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 | Lifestyle | - | - | Dinacarya: Lifestyle changes
Wake up between 6 and 7 am, go to bed between 10 and 11 pm, avoid daytime sleepiness and nighttime wakefulness, and get 6 to 8 hours of sleep.
Meditate for ten minutes (sit in meditation). Drink a glass of warm water and do yoga, pranayama and exercise as much as you can for 1 to 18 hours after breakfast (asanas Padmasana, 1 to 2 Surya Namaskar etc. Exercise : brisk walking, climbing stairs, cycling, playing sports like football and volleyball, dancing, zumba, swimming, etc.)
Then, apply the udvartana with utana and take a bath with warm water.
Eat food at the right time, in the right quantity and with the right ingredients. Avoid sitting in one place for too long. Follow Sadvrutta and Brahmacharya. Control anxiety and mental emotions. Avoid negative thinking., Ritucarya: , Acara Rasayana:, Other:
, Pathya/Apathya:yes, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who fulfill the diagnostic criteria of Prameha (Diabetes Mellitus Type II) and regularly taking anti-diabetic drugs.
2. Age group having 30 to 60 Years age – Irrespective of any gender, religion, socioeconomic status, Blood Sugar Level, HbA1c level.
|
|
| ExclusionCriteria |
| Details |
1. Patients with Diabetes Mellitus Type I or on Insulin or not willing to participate
2. Pregnant, lactating women or on oral contraceptives
3. Known case of Uncontrolled Diabetes with its complications, Hypothyroidism, Cardiovascular, Neurological, Renal disorders and Drug induced obesity
4. Known case of acute complications like Chronic Heart Disease, Hepatitis
5. Known cases of Major systemic diseases such as Acquired Immuno Deficiency Syndrome, Ischemic Heart Disease, Carcinoma, Renal and Cerebral diseases
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effects of Dietary and Lifestyle Modifications in Prameha (Diabetes Mellitus Type ll) patients with special reference to Blood Sugar Level and HbA1c. |
Patients will be assessed on 30th, 60th, 90th day of follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To study the Nidanapanchaka of Prameha According to Ayurveda Samhitas.
2) To study Diabetes Mellitus according to Modern Science.
3) To study the Blood Sugar Level test.
4) To study the HbA1c test.
|
Patients will be assessed on 30th, 60th, 90th day of follow up |
|
|
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 2 |
|
Date of First Enrollment (India)
|
27/07/2025 |
| 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="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
|
Prameha :
Disease where more or excess urination is called as Prameha. According to WHO, Diabetes Mellitus is a metabolic disorder of multiple etiologies, including inappropriate diet and lifestyle habbits.
Chikitsa :
Prameha is treated by shodhan as well as shaman chikitsa, but shodhan chikitsa is mind difficult to administer and its time taking. Diet and Lifestyle Modifications may help in Prameha patients for prevention from complications of disease and cure from present disease.
BSL & HbA1c : These both are markers for Diebetes Mellitus.
|