| CTRI Number |
CTRI/2024/11/076459 [Registered on: 08/11/2024] Trial Registered Prospectively |
| Last Modified On: |
08/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To Check The effect Of Different Species Of Chirayata In Fever |
|
Scientific Title of Study
|
To Evaluate The Clinical Efficacy Of a Variety Of Chirayata Swertia purpurascens D.Don C.B.Clarke as Jwaraghna in Pratishyaya |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ProfNavneetKumarSharma |
| Designation |
Professor |
| Affiliation |
R.G.G P.G AYURVEDIC COLLEGE PAPROLA |
| Address |
Room 205 Dravyaguna department Old Building Rajiv Gandhi Government Post graduate Ayurvedic College Paprola Dist Kangra Himachal Pradesh
Near Sai University Padiharkhar dist- Kangra Himachal pardesh
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418080689 |
| Fax |
|
| Email |
dr.navneetsharma@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Chinmay mohanty |
| Designation |
Pg scholar |
| Affiliation |
R.G.G P.G AYURVEDIC COLLEGE PAPROLA HIMACHAL PRADESH |
| Address |
Room205 Dravyaguna deptt old building Rajiv Gandhi Government Postgraduate Ayurvedic College Paprola
Dist Kangra Himachal Pradesh
Rajiv Gandhi Ayurvedic college boys hostel room no.10
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
6370016370 |
| Fax |
|
| Email |
chinmaymohanty629@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Navneet Kumar Sharma |
| Designation |
Professor |
| Affiliation |
R.G.G P.G AYURVEDIC COLLEGE PAPROLA |
| Address |
Room205 Dravyaguna deptt old building Rajiv Gandhi Government Postgraduate Ayurvedic College Paprola Dist Kangra Himachal
Pradesh
House Number 03 Near Sai university village Padharkhar Kangra Himachal Pradesh
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418080689 |
| Fax |
|
| Email |
dr.navneetsharma@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Rajiv gandhi govt. Post graduate Ayurvedic college and hospital Paprola himachal pardesh 176115 |
|
|
Primary Sponsor
|
| Name |
Prof Navneet Kumar Sharma |
| Address |
R.G.G P.G AYURVEDIC COLLEGE AND HOSPITAL PAPROLA Himachal Pradesh 176115 |
| 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 Chinmay Mohanty |
Rajiv Gandhi Government Ayurvedic hospital |
OPD 209 Department of Dravyaguna
Kangra
HIMACHAL PRADESH |
6370016370
chinmaymohanty629@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RajivGandhigovernmentpostgraduateayurvediccollegeandhospitalpaproladisttkangraHPAyurvediccollegeroadPaprolaDisttkangraHPInstitutionalethicscommitteeHuman |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J00||Acute nasopharyngitis [common cold]. Ayurveda Condition: PRATISYAYA-UPADRAVAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: chirayitatablet, Reference: Rajnighantu, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Antarabhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -lukewarmwater), Additional Information: -none |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
patient willing for trial |
|
| ExclusionCriteria |
| Details |
patient not willing for trial known case of other chest pathology known case of nasal polyp epistaxis Age below 16years and above70 years |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| relief from the symptoms of the patients |
3rd day and last 7th day of trial |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Cure the root cause of the disease. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/11/2024 |
| 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="25"
Months="6"
Days="10" |
|
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
|
For the trial, subject will be selected from the OPD/IPD of R.G.G P.GAyurvedic College and Hospital, Paprola. There will be 30 patients who will be registered and assessed to evaluate the effect of Chirayita in Pratishyaya Jwaraghna. |