| CTRI Number |
CTRI/2024/05/067568 [Registered on: 17/05/2024] Trial Registered Prospectively |
| Last Modified On: |
16/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of IgE level on Tamak Swas |
|
Scientific Title of Study
|
Diagnostic evaluation of Tamak Swas on the basis of IgE level |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Smirti Priyanshu |
| Designation |
MD (Scholar) |
| Affiliation |
Government Ayurvedic College & Hospital Patna |
| Address |
Department of Rog Nidaan evam Vikriti Vigyaan, Government Ayurvedic College & Hospital Patna
Patna
BIHAR
800003
India |
| Phone |
7717790935 |
| Fax |
|
| Email |
smritipriyanshu5244@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Basant Kumar Thakur |
| Designation |
Professor |
| Affiliation |
Government Ayurvedic College & Hospital Patna |
| Address |
Department of Rog Nidaan evam Vikriti Vigyan, Government Ayurvedic College & Hospital Patna
Patna
BIHAR
800003
India |
| Phone |
9430252475 |
| Fax |
|
| Email |
drbkthakur@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Basant Kumar Thakur |
| Designation |
Professor |
| Affiliation |
Government Ayurvedic College & Hospital Patna |
| Address |
Department of Rog Nidaan evam Vikriti Vigyaan, Government Ayurvedic College & Hospital Patna
Patna
BIHAR
800003
India |
| Phone |
9430252475 |
| Fax |
|
| Email |
drbkthakur@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic College & Hospital Patna, Kadamkuan, Patna, Bihar, India 800003 |
|
|
Primary Sponsor
|
| Name |
Dr Smirti Priyanshu |
| Address |
Department of Rog Nidaan evam Vikriti Vigyan, Government Ayurvedic College & Hospital Patna, Kadamkuan, Patna, Bihar, India 800003 |
| Type of Sponsor |
Other [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 |
| Dr Smirti Priyanshu |
Government Ayurvedic College & Hospital Patna |
Department of Rog Nidaan, Government Ayurvedic College & Hospital Patna, Kadamkuan, Patna, Bihar, India 800003
Patna
BIHAR |
7717790935
smritipriyanshu5244@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J454||Moderate persistent asthma. Ayurveda Condition: TAMAKASVASAH, |
|
|
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 |
The age of patient should be between 20-60 years.
The sign and symptom of the patients should be based on ayurvedic views. |
|
| ExclusionCriteria |
| Details |
Pregnant and lactating women.
Life threatening disorders. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of tamaka swasa symptoms like ghurghurakam,swasakrichrata,anidra,ura parswa peeda, nishtyutante,aseeno labhate saukhyam on the basis of ige. |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluation of additional symptoms |
15 days |
|
|
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)
|
03/06/2024 |
| 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="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This study is an observational study to know the disease tamak swas on the basis of IgE level, that will be conducted in Government Ayurvedic College and Hospital at Patna, Bihar in the department of Rognidan Evam Vikriti Vigyan in a group of 60 patients. |