| CTRI Number |
CTRI/2024/12/078230 [Registered on: 17/12/2024] Trial Registered Prospectively |
| Last Modified On: |
12/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To study the relation between Eight Cardinal Symptoms of Obesity Related disorder in Obese diabetic patients with Special Reference to HbA1C Levels |
|
Scientific Title of Study
|
An observational study of Ashtadosha lakshana of Medoroga in sthool pramehi with special reference to HbA1C level |
| Trial Acronym |
NIl |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vd Rajashri Ganpat Mane |
| Designation |
B.A.M.S. PG Scholar |
| Affiliation |
Department of Rognidan Avum Vikriti vigyana |
| Address |
Ayurved Rugnalay and sterling multispeciality hospital pathology lab
room no. 115 sector no.27 pradhikaran nigdi pune. PDEAs College
of Ayurved And Research Centre Nigdi Pune
room no. 115 sector no.27 pradhikaran nigdi pune. PDEAs College
of Ayurved And Research Centre Nigdi Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
8007047247 |
| Fax |
|
| Email |
rgmane22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR RAGINI R PATIL |
| Designation |
Head of the Department |
| Affiliation |
Department of Rognidan Avum Vikriti vigyana |
| Address |
Ayurved Rugnalay and sterling multispeciality hospital pathology lab
room no. 115 sector no.27 pradhikaran nigdi pune. PDEAs College
of Ayurved And Research Centre Nigdi Pune
room no. 115 sector no.27 pradhikaran nigdi pune. PDEAs College
of Ayurved And Research Centre Nigdi Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9422300242 |
| Fax |
|
| Email |
patilragini26@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Vd Rajashri Ganpat Mane |
| Designation |
B.A.M.S. PG Scholar |
| Affiliation |
Department of Rognidan Avum Vikriti vigyana |
| Address |
Ayurved Rugnalay and sterling multispeciality hospital pathology lab
room no. 115 sector no.27 pradhikaran nigdi pune. PDEAs College
of Ayurved And Research Centre Nigdi Pune
room no. 115 sector no.27 pradhikaran nigdi pune. PDEAs College
of Ayurved And Research Centre Nigdi Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
8007047247 |
| Fax |
|
| Email |
rgmane22@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College of Ayurved and Research Centre Nigdi Pune Maharashtra 411044
|
|
|
Primary Sponsor
|
| Name |
Not Applicable |
| Address |
Not Applicable |
| Type of Sponsor |
Other [Not Applicable] |
|
|
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 |
| Vd Rajashri Ganpat Mane |
PDEAs Ayurved Rugnalay and Sterling multispeciality Hospital, Nigdi pradhikaran Pune |
Pathology lab room no
115 sector 27
Pradhikaran Nigdi Pune
Pune MAHARASHTRA
Pathology lab room no
115 sector 27
Pradhikaran Nigdi,
Pune
Pune
MAHARASHTRA
,Nigdi,Pune 411044
Pune
MAHARASHTRA |
8007047247
rgmane22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Pune District Education Associations College of Ayurved and Research Centre Sector No 25 Pradhikaran Nigdi Pune 411044 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E00-E89||Endocrine, nutritional and metabolic diseases. Ayurveda Condition: PRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
known cases of Diabetes Mellitus having BMI≥25kg/m2 |
|
| ExclusionCriteria |
| Details |
1.Patients suffering from Tuberculosis, Rheumatoid arthritis and Thyroid.
2. Patient’s on steroidal medications.
3. Known cases of Systemic lupus erythematous, Malignancy etc.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the realationship of Eight Cardinal Symptoms of Obesity Related disorder in Obese diabetic patients with Special Reference to HbA1C Levels |
12 Months |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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
|
N/A |
|
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="1"
Months="6"
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
|
1) Title An observational study of Ashtadosha lakshana of Medoroga in sthool pramehi with
special reference to HbA1C level.
2) Objectives Primary Objective -To study the relation between Ashtadosha lakshana of Medoroga
and HbA1C level in sthool pramehi. Secondary Objective- To study the relation between Ashtadosha lakshana of
Medoroga and BMI in sthool Pramehi.
3) Methodology I. APPROPRIATE STUDY DESIGN –
It is an Observational study. II.STUDY SETTING –
The proposed study will be done in three levels. L EVEL 1 (CONCEPTUAL) – Ayurvedic literature regarding Ashtadosha lakshana of
Medoroga, Sthool Pramehi, modern concept of Type 2 Diabetes mellitus, and HbA1C
will be studied. LEVEL 2 (OBSERVATIONAL) –Observation of Ashtadosha lakshanas of Medoroga in
sthool pramehi with special reference to HbA1C will be done. LEVEL 3 (ANALYSIS) – Analysis of generated data will be performed for Qualitative and
Quantitative data for result. STUDY PLACE –Institutional Hospital STUDY DURATION –18 Months. III.STUDY POPULATION –
6
Known cases of Diabetes mellitus having BMI ≥25kg/m2 IV.SAMPLE SIZE –4(pq)/e2
p-prevalence rate i.e.0.11[16]
q=1-p=0.89
e=allowable error=0.08
sample size=4(pq)/e2
=4*0.11*0.89/ (0.08)2
=61.187 For convenience purpose 70 patients will be taken V. APPROPRIATE SAMPLING TECHNIQUE –
Purposive sampling technique will be taken. VI.METHOD OF SELECTION OF STUDY SUBJECT – A. INCLUSION CRITERIA –
1. Age group between 30 to 60 years
2. known cases of Diabetes Mellitus having BMI≥25kg/m2
3. Irrespective of gender, caste, socio-economical class and marital status. B. EXCLUSION CRITERIA –
1.Patients suffering from Tuberculosis, Rheumatoid arthritis and Thyroid.
2. Patient’s on steroidal medications.
3. Known cases of Systemic lupus erythematous, Malignancy etc. |