| CTRI Number |
CTRI/2023/11/060192 [Registered on: 23/11/2023] Trial Registered Prospectively |
| Last Modified On: |
10/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effect of Masura yusha as Pathya in lowering the blood glucose level in Prediabetes |
|
Scientific Title of Study
|
A randomized controlled clinical study to evaluate the effect of Masura yusha as Pathya in Prediabetes |
| 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 LIKHITHA H K |
| Designation |
PG SCHOLAR, DEPARTMENT OF PG STUDIES IN SWASTHAVRITTA, ALVAS AYURVEDA MEDICAL COLLEGE |
| Affiliation |
ALVAS AYURVEDA MEDICAL COLLEGE AND HOSPITAL |
| Address |
ALVAS AYURVEDA MEDICAL COLLEGE AND HOSPITAL, VIDYAGIRI,
MOODABIDIRE, DAKSHINA KANNADA, KARNATAKA
574227, INDIA
MOODUBIDIRE, DAKSHINA KANNADA, KARNATAKA
574227, INDIA
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9481660944 |
| Fax |
|
| Email |
likhithachidgal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR NAGENDRA KUMAR BC |
| Designation |
PROFESSOR AND HOD, DEPARTMENT OF PG STUDIES IN SWASTHAVRITTA |
| Affiliation |
ALVAS AYURVEDA MEDICAL COLLEGE AND HOSPITAL |
| Address |
ALVAS AYURVEDA MEDICAL COLLEGE AND HOSPITAL, VIDYAGIRI,
MOODABIDIRE, DAKSHINA KANNADA, KARNATAKA
574227, INDIA
MOODABIDIRE, DAKSHINA KANNADA, KARNATAKA
574227, INDIA
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9844471581 |
| Fax |
|
| Email |
nagendra.k18@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR NAGENDRA KUMAR BC |
| Designation |
PROFESSOR AND HOD, DEPARTMENT OF PG STUDIES IN SWASTHAVRITTA |
| Affiliation |
ALVAS AYURVEDA MEDICAL COLLEGE AND HOSPITAL |
| Address |
ALVAS AYURVEDA MEDICAL COLLEGE AND HOSPITAL, VIDYAGIRI,
MOODABIDIRE, DAKSHINA KANNADA, KARNATAKA
574227, INDIA
MOODABIDIRE, DAKSHINA KANNADA, KARNATAKA
574227, INDIA
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9844471581 |
| Fax |
|
| Email |
nagendra.k18@gmail.com |
|
|
Source of Monetary or Material Support
|
| ALVAS AYURVEDA MEDICAL COLLEGE AND HOSPITAL |
|
|
Primary Sponsor
|
| Name |
LIKHITHA H K |
| Address |
ALVAS AYURVEDA MEDICAL COLLEGE AND HOSPITAL, VIDYAGIRI,
MOODABIDIRE, DAKSHINA KANNADA, KARNATAKA
574227, INDIA |
| 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 |
| LIKHITHA H K |
ALVAS AYURVEDA MEDICAL COLLEGE AND HOSPITAL |
OPD NUMBER - 8, DEPARTMENT OF SWASTHAVRITTA, ALVAS AYURVEDA
MEDICAL COLLEGE AND HOSPITAL
VIDYAGIRI, MOODABIDIRE
MOODUBIDIRE, DAKSHINA KANNADA,
KARNATAKA - 574227
Dakshina Kannada
KARNATAKA |
9481660944
likhithachidgal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL CLINICAL ETHICS COMMITTEE, ALVAS AYURVEDA MEDICAL COLLEGE |
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 | Classical | | (1) Medicine Name: MASURA YUSHA, Reference: YOGARATNAKARA, PURVAKHANDA, SIDDHANNA VARGA, MASURA YUSHA, Route: Oral, Dosage Form: Dravaka, Dose: 150(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: | | 2 | Comparator Arm | Lifestyle | - | - | Dinacarya: Not applicable, Ritucarya: Not applicable, Acara Rasayana:Not applicable, Other:Dietary Intervention, Pathya/Apathya:yes, Pathya:A common Diet chart based on Protocol for Prevention and Control of Diabetes through Ayurveda – Ministry of AYUSH. Govt. of India will be advised for 15 days. Diet chart contains 3 meals per day for 15 days., Apathya:Not applicable |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Fasting Plasma Glucose value between
100mg/dl – 125mg/dl
2. 2hr Plasma Glucose or OGTT value between
140mg/dl – 199mg/dl
3. Patients with or without following
features of Pre-diabetes:
-Increased thirst
-Frequent desire to urinate
|
|
| ExclusionCriteria |
| Details |
1. FPG value ≥ 126mg/dl
2. OGTT value ≥ 200mg/dl
3. Patients under Hypoglycemic drugs
4. Gestational diabetes
5. Patient with chronic systemic diseases
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Effect of treatment will be assessed on the basis
of gradation of both subjective and objective
parameters before and after treatment.
Subjective parameter:
• Increased thirst
• Frequent desire to
urinate
Scoring will be given to each parameter and will be assessed before and after the intervention.
Objective parameter:
• FBS
• PPBS
|
Study duration:45 days
15 days of intervention and follow up on 30th and 45th day.
OBSERVATION PERIOD: Patient will be assessed on 0th day and on 15th, 30th, 45th day.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Effect of treatment will be assessed on the basis
of FBS & PPBS before & after the treatment, 30th day & 45th day.
|
Study duration:45 days
15 days of intervention & follow up on 30th & 45th day.
OBSERVATION PERIOD: Patient will be assessed on 0th day & on 15th, 30th, 45th day.
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/12/2023 |
| 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="1"
Days="5" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
A minimum of 60 patients fulfilling the inclusion, exclusion and diagnostic criteria of Pre-diabetes irrespective of gender, religion, occupation, marital status and socio-economic status will be selected from OPD and IPD of Alvas ayurveda medical college and hospital and randomly divided into two equal groups, group A and group B. GROUP A: 30 patients of group A will be advised to follow Dietary Interventions for 15 days. GROUP B: 30 patients of group B will be given with 150ml of Masura Yusha once in a day at night time and advised to follow Dietary Interventions for 15 days. Patients will be assessed on 0th day and on 15th, 30th, 45th day. Patient will be assessed with subjective and objective parameters formulated and the data obtained will be recorded and statistically analysed. The study will be published in a reputed journal after the completion. |