| CTRI Number |
CTRI/2022/04/041912 [Registered on: 19/04/2022] Trial Registered Prospectively |
| Last Modified On: |
13/04/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to evaluate the influence of strength of satva in Pulmonary Tuberculosis patients |
|
Scientific Title of Study
|
Development of scale for the assessment of strength of Satva and to evaluate its influence on RÄjayaká¹£mÄ with special reference to Pulmonary Tuberculosis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arunima P S |
| Designation |
PG Scholar |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Vikriti Vigyan,Faculty of Ayurveda, Institute of Medical Science, Banaras Hindu University, Varanasi,
Uttar Pradesh, India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7356259443 |
| Fax |
|
| Email |
arunimaps888@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof P S Byadgi |
| Designation |
Professor |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Vikriti Vigyan,Faculty of Ayurveda, Institute of Medical Science, Banaras Hindu University, Varanasi,
Uttar Pradesh, India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9450711759 |
| Fax |
|
| Email |
psbyadgi@bhu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Arunima P S |
| Designation |
PG Scholar |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Vikriti Vigyan,Faculty of Ayurveda, Institute of Medical Science, Banaras Hindu University, Varanasi,
Uttar Pradesh, India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7356259443 |
| Fax |
|
| Email |
arunimaps888@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Vikriti Vigyan,Faculty of Ayurveda, Institute of Medical Science, Banaras Hindu University, Varanasi,
Uttar Pradesh, India |
|
|
Primary Sponsor
|
| Name |
Institute of Medical Science Banaras Hindu University Varanasi Uttar Pradesh India |
| Address |
Department of Vikriti Vigyan,Faculty of Ayurveda, Institute of Medical Science, Banaras Hindu University, Varanasi,
Uttar Pradesh, India |
| 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 |
| ARUNIMA P S |
Sir Sunderlal Hospital |
Department of Vikriti Vigyan,Faculty of Ayurveda Institute of Medical Science , Banaras Hindu University,Varanasi Uttar Pradesh
Department of Kayacikitsa,Faculty of Ayurveda Institute of Medical Science , Banaras Hindu University,Varanasi, Uttar Pradesh
Department of TB and Chest,Institute of Medical Science , Banaras Hindu University,Varanasi, Uttar Pradesh
Varanasi
UTTAR PRADESH |
7356259443
arunimaps888@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A150||Tuberculosis of lung, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Confirmed pulmonary tuberculosis patients irrespective of gender
2.Patients with well controlled comorbid conditions
3.Age group between 18-70 years
|
|
| ExclusionCriteria |
| Details |
1.Not willing to complete the consent process as describe in proforma.
2.Inability to comply with study procedures and methods.
3.HIV patients
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the type of Satva and its role in response to the treatment of Pulmonary Tuberculosis. |
1.5yr |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the association of types of Satva with adverse reactions and complications of Pulmonary Tuberculosis. |
1.5 yr
|
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
25/04/2022 |
| 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="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
|
This study is a single group prospective observational study to evaluate the strength of satva and its role in Pulmonary Tuberculosis. The primary outcome will association of the type of Satva and its role in response to the treatment of Pulmonary Tuberculosis. The secondary outcome will be the association of types of Satva with adverse reactions and complications of Pulmonary Tuberculosis. |