| CTRI Number |
CTRI/2021/12/039026 [Registered on: 29/12/2021] Trial Registered Prospectively |
| Last Modified On: |
01/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
SURVEY STUDY TO ASSESS URDHWA-TRIKSANDHARAN KARMA OF AVALAMBAKA KAPHA IN TAILORS |
|
Scientific Title of Study
|
AN OBSERVATIONAL STUDY TO ASSESS URDHWA-TRIKSANDHARAN KARMA OF AVALAMBAKA KAPHA IN TAILORS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Meghana Sopan Darvatkar |
| Designation |
MD Scholar |
| Affiliation |
MAMS Sumatibhai Shah Ayurved Mahavidyalaya Hadapsar 28 |
| Address |
Department of Kriya sharir MAMS Sumatibhai Shah Ayurved Mahavidyalaya Malwadi, Hadapsar Pune
5/2/3/1 AMBEGAON BUDRUK SINHGAD ROAD DHABADI SADASHIV DAGAT NAGAR PUNE
Pune
MAHARASHTRA
411028
India |
| Phone |
8830987244 |
| Fax |
|
| Email |
darvatkarmeghana1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anil Deshpande |
| Designation |
Lecturer |
| Affiliation |
MAMS Sumatibhai Shah Ayurved Mahavidyalaya Hadapsar 28 |
| Address |
Department of Kriya Sharir MAMS Sumatibhai Shah Ayurved Mahavidyalaya Malwadi, Hadapsar Pune
MAMS Sumatibhai shah Ayurved Mahavidyalya Malwadi, Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
8830987244 |
| Fax |
|
| Email |
deshpandeanil04@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Meghana Sopan Darvatkar |
| Designation |
MD Scholar |
| Affiliation |
MAMS Sumatibhai Shah Ayurved Mahavidyalaya Hadapsar 28 |
| Address |
Department of Kriya Sharir MAMS Sumatibhi Shah Ayurved Mahavidyalaya Malwadi, Hadapsar Pune
5/2/3/1 Ambegaon Budruk sinhgad road dhabadi sadashiv dangat nagar pune
Pune
MAHARASHTRA
411028
India |
| Phone |
8830987244 |
| Fax |
|
| Email |
darvatkarmeghana1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Kriya Sharir MAMS Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune 411028 |
|
|
Primary Sponsor
|
| Name |
Meghana Sopan Darvatkar |
| Address |
Department of Kriya Sharir MAMS Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune 411028 |
| Type of Sponsor |
Other [[PRINCIPLE INVESTIGATOR (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 |
| Meghana Sopan Darvatkar |
Sane Guruji Arogya Kendra Malwadi |
MAMS Sumatibhai Shah Ayurved Mahavidyalaya and Sane Guruji Arogya Kendra opd 2 Malwadi, Hadapsar Pune 411028
Pune
MAHARASHTRA |
8830987244
darvatkarmeghana1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAMS Sumatibhai Shah Ayurved Mahavidyalaya and Sane guruji Arogya Kendra Malwadi Hadpsar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Individuals working in Tailoring Profession |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Individuals doing tailoring work for more than 5 years At least 5 days per week and more than 6 hours per day conventional tailors |
|
| ExclusionCriteria |
| Details |
Individuals having H/O major illness in the past regarding cervical spine H/O surgical intervention regarding cervical spine Any known congenital disease |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess Urdhwa-Trikasandhrana Karma of Avalambaka Kapha in tailors |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess Urdhwa-Trikasandhrana Karma of Avalambaka Kapha in tailors |
1 day |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/02/2022 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This is an Observational study to Assess Urdhwa-Trikasandharana Karma of Avalambaka Kapha in Tilors, i.e. Individuals working in tailoring profession may have problems related to vertibro-occipital and acromio-humeral joint as term Trika corresponds to these joints. By the assessment of Urdhwa-Trikasandharana Karma of Avalambaka Kapha in Tilors rate of future disease/disorders can be identified.
Individuals of either gender working in tailoring Profession for more than 5 years At least 5 days per week and more than 6 hours per day will be selected for the study. Urdhwa-Trikasandharana Karma of Avalambaka Kapha can be assessed and quality of life can be improved by reducing rate of future diseases. |