| CTRI Number |
CTRI/2023/02/050095 [Registered on: 27/02/2023] Trial Registered Prospectively |
| Last Modified On: |
25/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study for testing whether Guduchi (Tinospora cordifolia) ghana vati along with Tab. Multivitamin is more effective in managing post COVID-19 fatigue than Tab. Multivitamin alone. |
|
Scientific Title of Study
|
Randomized controlled clinical trial of add on effect of Guduchi(Tinospora cordifolia (Wild.)Miers)ghana vati with tab. Multivitamin on post covid- 19 Klama (fatigue) |
| 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 Patil |
| Designation |
PG Scholar |
| Affiliation |
Tilak ayurved Mahavidyalaya |
| Address |
Tilak Ayurved Mahavidyalaya, Second floor,Jagtap road, Rasta peth, Dravyaguna vibhag, Pune 411011.
Pune
MAHARASHTRA
411011
India |
| Phone |
9764231293 |
| Fax |
|
| Email |
patilsnehav1111@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Apoorva Sangoram |
| Designation |
Head of department , Dravyaguna Vibhag |
| Affiliation |
Tilak ayurved Mahavidyalaya |
| Address |
Tilak Ayurved Mahavidyalaya, Second floor,Jagtap road, Rasta peth, Dravyaguna vibhag, Pune 411011.
Pune
MAHARASHTRA
411011
India |
| Phone |
9822090305 |
| Fax |
|
| Email |
apoorvasangoram@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Apoorva Sangoram |
| Designation |
Head of department , Dravyaguna vibhag |
| Affiliation |
Tilak ayurved Mahavidyalaya |
| Address |
Tilak Ayurved Mahavidyalaya, Second floor,Jagtap road, Rasta peth ,Dravyaguna vibhag, Pune 411011.
Pune
MAHARASHTRA
411011
India |
| Phone |
9822090305 |
| Fax |
|
| Email |
apoorvasangoram@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sheth Tarachand Ramnath Charitable Ayurvedic Hospital, Rasta peth , pune 411011. OPD: Kayachikoitsa OPD,Ground floor,OPD building of Hospital. |
|
|
Primary Sponsor
|
| Name |
Dr. Sneha Patil |
| Address |
Tilak ayurved Mahavidyalaya, second floor,jagtap road, rasta peth Dravyaguna vibhag, pune 411011 |
| 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 Sneha Patil |
Sheth Tarachand Ramnath Charitable Ayurveda Hospital |
Kayachikitsa OPD, Sheth Tarachand Ramnath Charitable Ayurveda Hospital,Rasta peth, Pune
Pune
MAHARASHTRA |
9764231293
patilsnehav1111@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee of TAMV |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:U071||COVID 19 virus identified. Ayurveda Condition: KLAMAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Tab. Supradyn, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 1(NA), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: Water), Additional Information: This is the conventional drug used for treating post COVID-19 fatigue | | 2 | Comparator Arm (Non Ayurveda) | | - | Tab. Supradyn | Route: Oral, Dosage form: Tablet, Dose: 1 Tablet, Frequency: od. | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Guduchi Ghana vati, Reference: Siddha Yog Samgraha, by Acharya Yadavji Trikamji, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -milk), Additional Information: Ayurvedic intervention will be given additional to the provisional medication. |
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with positive RTPCR test for COVID-19 dating back 20 to 60 days from the date of screening
2.Patients showing symptoms of Fatigue post COVID19. |
|
| ExclusionCriteria |
| Details |
1.known cases of immunosuppressive disorders.
2.Known case of or known history of major disorders like Cancer, Renal failure, Cardiac disorders. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Guduchi (Tinospora cordyfolia) Ghana vati when used with Tab. Multivitamin releives the symptoms of post COVID-19 klama (fatigue) more effectively than Tab.Multivitamin alone.when tested fatigue with Chalder fatigue scale. |
follow up on baseline,1st week,2nd week,3rd week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Guduchi ghanavati improves Agni of participants when the Abhyavaran shakti of patients compared before and after study. |
follow up on 2nd and 3rd week |
| Guduchi ghana Vati increases weight of patients when measured with weighing scale, before and after treatment. |
Follow up on 2nd and 3rd week |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/03/2023 |
| 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="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
This study is a randomized parallel group active controlled study to evaluate the add on effect of Guduchi (Tinospora cordyfolia) along with Tab. Multivitamin in Post COVID-19 Klama or Fatigue. Assessment criteria - Primary outcome measures will be Objective criteria: Fatigue assessment by Chalder Fatigue Scale (CFQ-11). Follow up on 0th,7th,14th and 21st day will be done. Subjective criteria : Personal relief in symptoms like feeling of tiredness, weakness, and other improvement signs like regaining enthusiasm in work etc. Follow up on 0th,7th,14th and 21st day will be done. Secondary outcome measure is measurement of improvement in quality of life, betterment of Agni (digestive power/metabolism) of patient , weight gain or improvement in power if any.
|