| CTRI Number |
CTRI/2022/05/042410 [Registered on: 09/05/2022] Trial Registered Prospectively |
| Last Modified On: |
19/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [to prevent post covid complications] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical trial of Amalaki Rasayan in post covid patients |
|
Scientific Title of Study
|
Manufacturing, Analysis And Exploratory Clinical Trial Of Charakokta Amalaki Rasayan in POST COVID Patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sneha Salunkhe |
| Designation |
MD Scholar |
| Affiliation |
BVDU College of Ayurved, Bharati Vidyapeeth (Deemed to be University), Pune 411043 |
| Address |
Department of Kayachikitsa opd no 4 Bharati Vidyapeeth Deemed University College of Ayurved pune 411043
Department of Kayachiktsa opd no 4 Bharati Vidyapeeth Deemed University College of Ayurved Pune 411043
Pune
MAHARASHTRA
411043
India |
| Phone |
02024373954 |
| Fax |
|
| Email |
snehasalunkhe400@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Trupti Patil |
| Designation |
Assistant Professor |
| Affiliation |
BVDU College of Ayurved, Bharati Vidyapeeth (Deemed to be University), Pune 411043 |
| Address |
Department of Rasashastra Bharati Vidyapeeth Deemed University College of Ayurved, Pune 411043
Pune
MAHARASHTRA
411043
India |
| Phone |
02024373954 |
| Fax |
|
| Email |
truptibhole@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Trupti Patil |
| Designation |
Assistant Professor |
| Affiliation |
BVDU College of Ayurved, Bharati Vidyapeeth (Deemed to be University), Pune 411043 |
| Address |
Department of Rasashastra Bharati Vidyapeeth Deemed University College of Ayurved Pune 411043
Pune
MAHARASHTRA
411043
India |
| Phone |
02024373954 |
| Fax |
|
| Email |
truptibhole@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth Deemed University College of Ayurveda Pune 411043 |
|
|
Primary Sponsor
|
| Name |
Sneha Janardan Salunkhe |
| Address |
Department of RSBK Bharati Vidyapeeth Deemed University College of Ayurveda Pune |
| Type of Sponsor |
Other [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 D L Shinde |
Bharati Vidyapeeth Deemed to be University College of Ayurveda PunePune 43 |
Department of Kayachikitsa Opd no 4 Bharati Vidyapeeth Deemed to be University Ayurveda Hospital Pune Satara Road Pune 43
Pune
MAHARASHTRA |
9890111954
dshinde249@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee [BV(DU)COA-EC] |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:B972||Coronavirus as the cause of diseases classified elsewhere. Ayurveda Condition: VATAKAPOLBANA-SANNIPATAJVARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Amalaki Rasayan , Reference: Charaksamhita Chikitsasthana 1-2/8, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 10(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -water ), Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Post covid patients beyond 4 weeks of infection up to one year after active infection of covid 19, patients having symptoms of fatigue, anorexia, anxiety, headache, joint pain, dysponea |
|
| ExclusionCriteria |
| Details |
Patients with active covid 19 infection, any critical emergencies including cardiac diseases, known case of asthma, COPD, ARDS, critical post covid complications like stroke, renal failure, myocarditis, mukermycosis, etc, uncontrolled DM, HTN |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in WHO well being index and improvement in symptoms after 30 days intervention |
Improvement in WHO well being index and improvement in symptoms after 30 days intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in WHO well being index and improvement in symptoms after 30 days intervention |
30th day after intervention |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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)
|
15/05/2022 |
| 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)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study has been approved by institutional ethics committee of College of Ayurved, Bharati Vidyapeeth (Deemed to be University), Pune. We shall recruit patients subject to getting approval from CTRI, India. |