| CTRI Number |
CTRI/2023/05/052306 [Registered on: 04/05/2023] Trial Registered Prospectively |
| Last Modified On: |
03/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
observational study of association of medovaha srotodushti in chronic kidney disease patients. |
|
Scientific Title of Study
|
An observational study of association of medovaha srotodusthi in patients of chronic kidney disease. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sneha Bhagwan Chate |
| Designation |
PG scholar |
| Affiliation |
Tilak ayurved mahavidyalaya, Pune |
| Address |
Tilak Ayurved Mahavidyalaya, rognidan department,Rasta Peth,Pune
Tarachand hospital,Rasta peth , pune
Pune
MAHARASHTRA
411011
India |
| Phone |
8999805330 |
| Fax |
|
| Email |
snehabchate@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aishwarya Ranade |
| Designation |
Assistant professor MD PhD Rognidan |
| Affiliation |
Tilak Ayurved Mahavidyalaya , Pune |
| Address |
Tilak Ayurved Mahavidyalaya, rognidan department,Rasta Peth,Pune
Tarachand hospital, Rasta Peth, Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
9423876727 |
| Fax |
|
| Email |
ashmr81@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aishwarya Ranade |
| Designation |
Assistant professor MD PhD Rognidan |
| Affiliation |
Tilak Ayurved Mahavidyalaya , Pune |
| Address |
Tilak Ayurved Mahavidyalaya,Rasta Peth,Pune.
Sheth Tarachand hospital,pune
Pune
MAHARASHTRA
411011
India |
| Phone |
9423876727 |
| Fax |
|
| Email |
ashmr81@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tilak Ayurved Mahavidyalaya,Rasta peth,Pune |
|
|
Primary Sponsor
|
| Name |
Tilak Ayurved Mahavidyalaya |
| Address |
Tilak Ayurved Mahavidyalaya,Rasta peth,Pune |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Sneha Bhagwan Chate |
Tilak ayurved mahavidyalaya |
Tilak Ayurved Mahavidyalaya,Rasta peth,Pune
Seth Tarachand Hospital
Pune
MAHARASHTRA |
8999805330
snehabchate@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| TILAK AYURVED MAHAVIDYALAYA AND SHETH TARACHAND RAMNATH CHARITABLE HOSPITAL INSTITUTIONAL ETHICS COMMITTEE |
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, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient will be selected irrespective of gender,religion,marital status,economical status.2. Known case of chronic kidney disease patients from affiliated hospital.3.patient who are dignosed for Chronic kidney disease with decreased estimated glomerular filtration of less thann 60ml/min/1.73m2 |
|
| ExclusionCriteria |
| Details |
1.Patients belonging to age group below 20years and 70years of age.2.Patients estimated glomerular filtration rate of above 60ml/min/1.73m2 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Association of medovaha srotodushti in the patients of chronic kidney disease |
18months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Association of meda dhatu kshaya in chronic kidney disease.
2. Association of meda dhatu vriddhi in chronic kidney disease. |
18 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
12/05/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
12/05/2023 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To Study of association of Medovaha srotodushti in patients of chronic kidney disease. In Ayurveda the metabolism amongst various tissues and organ systems is described with concept of srotas. Srotas are the micro-channels that provide nutrition to subsequent dhatus(tissue). The normalcy of srotasas in both structural and functional way is important to maintain health status of body. Various Acharyas, have described srotasas like Rasavaha srotas, Raktavaha srotas, Medovaha srotas, etc. In Ayurveda ahara digested by agni, it convert into rasa and subsequent dhatus. Acharya Charak, stated the function of meda dhatu as to maintain sneha in body. This sneha is transported via medovaha srotas. Vitiation of the Medovaha srotas leads to diseases like Prameha, Sthoulya, etc To study association of Meda dhatu kshaya in patients of chronic kidney disease. To study association of Meda dhatu vriddhi in patients of chronic kidney disease. |