| CTRI Number |
CTRI/2024/11/076991 [Registered on: 19/11/2024] Trial Registered Prospectively |
| Last Modified On: |
13/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
An observational study of association of rasavaha srotas dushti and sleep pattern |
|
Scientific Title of Study
|
An observational study of association of rasavaha srotas dushti and sleep pattern |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
BALAJI TRYAMBAKRAO BIRADAR |
| Designation |
PG Scholar |
| Affiliation |
Tilak Ayurveda Mahavidyalaya |
| Address |
Rognidan Department,Tilak Ayurveda Mahavidyalaya Rasta peth pune Tarachand hospital rasta peth Maharashtra 411011
Pune
MAHARASHTRA
411011
India |
| Phone |
7517813934 |
| Fax |
|
| Email |
balaji.biradar333@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vidya Naik |
| Designation |
MD Associate Professor ( Rognidan Evum Vikriti Vigyan) |
| Affiliation |
Tilak Ayurveda Mahavidyalaya |
| Address |
Rognidan Department, Tilak Ayurveda Mahavidyalaya Rasta peth pune Tarachand hospital Rasta peth Pune Maharashtra pin code 411011
Pune
MAHARASHTRA
411011
India |
| Phone |
9422003150 |
| Fax |
|
| Email |
vidya.r.naik@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vidya Naik |
| Designation |
MD Associate Professor ( Rognidan Evum Vikruti Vigyan) |
| Affiliation |
Tilak Ayurveda Mahavidyalaya |
| Address |
Rognidan Department, Tilak Ayurveda Mahavidyalaya Rasta peth pune Tarachand hospital Rasta Peth pune Maharashtra pin code 411011
Pune
MAHARASHTRA
411011
India |
| Phone |
9422003150 |
| Fax |
|
| Email |
vidya.r.naik@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tilak Ayurveda Mahavidyalaya Rasta peth pune Maharashtra pin code 411011, India |
|
|
Primary Sponsor
|
| Name |
Tilak Ayurveda Mahavidyalaya |
| Address |
Tilak Ayurveda Mahavidyalaya Rasta peth pune Maharashtra pin code 411011 |
| 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 |
| Dr Balaji Tryambakrao Biradar |
Seth Tarachand Ramnath Charitable Ayurvedic Hospital Pune |
Rognidan Department, Seth Tarachand Ramnath Charitable Ayurvedic Hospital Rasta Peth Pune pin code 411011
Pune
MAHARASHTRA |
7517813934
balaji.biradar333@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tilak Ayurved Mahavidyalaya And Seth Tarachand Ramnath Charitable Ayurvedic Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:R69||Illness, unspecified. Ayurveda Condition: RASAVAHASROTODUSHTIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Participant will be selected irrespective of religion, marital status, economical status.
2) Participant having any of the following symptoms- Ashradha, Aruchi, Asyavairsya, Arasynata, Hrullasa, Gourav, Tandra, Angamarda, Jwar, Tam, panduta, srotasrodha, klaibya, agnisaad, krushaangata, agnisaad, ayatakal vali, ayatakal palitya. |
|
| ExclusionCriteria |
| Details |
1) Participant belonging to age group below 20 years and above 60 years of age.
2) Known case of Major illness (For ex.Heart diseases,Lungs diseases, Brain diseases and diseases including all vital organs) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the Association of rasavaha srotas dushti and sleep pattern. |
18 months, 0 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the effect of sleep pattern on Rasadhatu |
18 months, 0 weeks |
|
|
Target Sample Size
|
Total Sample Size="97"
Sample Size from India="97"
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)
|
15/12/2024 |
| 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
|
To study the Association of rasavaha srotas dushti and Sleep pattern . To Study the effect of sleep pattern on Rasadhatu vruddhi lakshana To Study the effect of sleep pattern on Rasadhatu kshay lakshana
|