| CTRI Number |
CTRI/2020/02/023484 [Registered on: 20/02/2020] Trial Registered Prospectively |
| Last Modified On: |
14/02/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
A Study to establish the association between Sheetsthan niwas(places devoid of sunlight) in Tamak Shwasa (Bronchial Asthma) |
|
Scientific Title of Study
|
Case Control Study to establish the association between Sheetsthan niwas in Tamak Shwasa (Bronchial Asthma) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashok kumar Madan singh |
| Designation |
Associate Professor |
| Affiliation |
chaudhary brahm prakash ayurved charak sasthan |
| Address |
Department of Rog nidan evum vikriti Vigyana.
Chaudhary brahm prakash ayurved charak sansthan.
najaffgarh. New delhi.
New Delhi
DELHI
110073
India |
| Phone |
9899867606 |
| Fax |
|
| Email |
ashokdagar01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashok kumar Madan singh |
| Designation |
Associate Professor |
| Affiliation |
chaudhary brahm prakash ayurved charak sasthan |
| Address |
Department of Rog nidan evum vikriti Vigyana.
Chaudhary brahm prakash ayurved charak sansthan.
najaffgarh. New delhi.
New Delhi
DELHI
110073
India |
| Phone |
9899867606 |
| Fax |
|
| Email |
ashokmadan01@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gulshan sharma |
| Designation |
pg scholar |
| Affiliation |
Guru Gobind Singh Indraprastha University, |
| Address |
Department of Rog nidan evum vikriti Vigyana.
Chaudhary brahm prakash ayurved charak sansthan.
najaffgarh. New delhi.
sector 16 c, Dwarka Delhi , 110078,
South West
DELHI
110073
India |
| Phone |
8544753982 |
| Fax |
|
| Email |
gulsharma00@gmail.com |
|
|
Source of Monetary or Material Support
|
| chaudhary bhram prakash ayurved charak sansthan. |
|
|
Primary Sponsor
|
| Name |
chaudhary bhram prakash ayurved charak sansthan |
| Address |
chaudhary bhram prakash ayurved charak sansthan.
new delhi. |
| Type of Sponsor |
Government medical college |
|
|
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 Gulshan Sharma |
chaudhary bhram prakash ayurved charak sansthan. |
DEPARTMENT OF ROGNIDAN AVUM VIKRITI VIGYAN.
South West
DELHI |
8544753982
gulsharma00@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC - CBPACS. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J454||Moderate persistent asthma, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
known case of tamak shawasa wsr to bronchial asthma patients.
patients of mild and moderate asthma according to NAEPP classification.
|
|
| ExclusionCriteria |
| Details |
patients of severe asthma.
bronchial asthma associated with other morbid disorders.
pregnant woman and lactating mother. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
compare the strength of association between sheetsthana nivasa in etiopathogenesis of tamak shawasa.
|
6 months.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
compare the strength of association between vitamin D defeciency in etiopathogenesis of tamaka shawasa.
|
6 MONTHS |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
25/02/2020 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
The study will be published in higher peer reviewed journals. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
shawasa word indicates both physiological and pathological state of respiration. tamaka shawsa is one of the five types of disease shawasa which reflects in pranvaha strotas but develops through amashaya. the main causative factors responsible for tamaka shawsa are dhooma, raja, ativyavaya, seethsthana nivasa and guru sheet bhojana. among the above mentioned nidana of tamaka shwasa the focus of present study is to ponder cheifly upon sheetsthana nivasa.
NULL HYPOTHESIS : There is non association between sheetsthana nivasa along with vitamin D level in etiopathogenensis of tamaka shawasa. ALTERNATE HYPOTHESIS: There is a significacant correlation between sheetsthana nivasa along with vitamin D level in etiopathogenensis of tamaka shawasa.
So the main aim of the study will be to compare the strength of association between sheetsthana nivasa , vitamin D defeciency in etiopathogenensis of tamaka shawasa. |