| CTRI Number |
CTRI/2023/02/050096 [Registered on: 27/02/2023] Trial Registered Prospectively |
| Last Modified On: |
22/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study of whether Jatamansi (Nordostachys jatamansi DC) fant along with conventional treatment is more effective in managing post COVID anxiety than conventional method alone. |
|
Scientific Title of Study
|
A Randomised Controlled Clinical Trial Of Add on Effect OF Jatamansi (Nardostachys Jatamansi DC) Fant With Conventional Post COVID Protocol in Post COVID Anxiety |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vd Mahesh Tambe |
| Designation |
PG Scholar |
| Affiliation |
Tilak Ayurved Mahavidyalaya Pune |
| Address |
Tilak Ayurved Mahavidyalaya and Seth Tarachand Ramnath Charitable Ayurved Hospital, Rasta peth Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
8275579044 |
| Fax |
|
| Email |
mt223333@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Asmita Jadhav |
| Designation |
Assistant professor |
| Affiliation |
Tilak Ayurved Mahavidyalaya Pune |
| Address |
Tilak Ayurved Mahavidyalaya and Seth Tarachand Ramnath Charitable Ayurved Hospital, Rasta peth Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
9922437678 |
| Fax |
|
| Email |
asmita.niramaya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Asmita Jadhav |
| Designation |
Assistant professor |
| Affiliation |
Tilak Ayurved Mahavidyalaya Pune |
| Address |
Tilak Ayurved Mahavidyalaya and Seth Tarachand Ramnath Charitable Ayurved Hospital, Rasta peth Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
9922437678 |
| Fax |
|
| Email |
asmita.niramaya@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. |
|
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Primary Sponsor
|
| Name |
Vd Mahesh Tambe |
| Address |
Sheth Tarachand Ramnath Charitable Ayurvedic Hospital, Rasta peth , pune 411011. OPD:Kayachikoitsa OPD,Ground floor,OPD building of Hospital. |
| Type of Sponsor |
Other [Self] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Vd Mahesh Tambe |
Sheth TarachandRamnath CharitableAyurveda Hospital |
Kayachikitsa OPD,Sheth TarachandRamnath Charitable AyurvedaHospital,Rasta peth,Pune
Pune
MAHARASHTRA |
8275579044
mt223333@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics Committee of TAMV |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F418||Other specified anxiety disorders. Ayurveda Condition: MANA-SANTAPAH, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Jatamansi, Reference: Bhavprakash, Route: Oral, Dosage Form: Phanta, Dose: 20(ml), Frequency: hs, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 4 Weeks, Reference: No, Route: NA, Dosage Form: Phanta, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: |
|
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Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Post covid patients of Mild and Moderate anxiety of age group 16-80 yrs. will be selected irrespective of their gender and religion.
2. As per clinical examination and specific anxiety disorder scale post covid patients fulfilling the criteria of Mild and Moderate anxiety will be selected.
3. Patients willing to give consent to participate in the trial.
|
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| ExclusionCriteria |
| Details |
1. Patients with known case of serious illness such as cancer, kidney disease, heart disease.
2. Patients with known case of Mental retardation or having any other psychological disorder.
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| Add on effect of Jatamansi (Nardostachys jatamansi DC) fant is more effective than conventional post covid protocol in management of post covid anxiety when tested with Hamiltons anxiety scale (HAM-A) |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Jatamansi (Nordostachys jatamansi) Fant improves Kanti, medha of patients |
Follow up on 7th, 14th, 21th and 28th day |
|
|
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
|
Non yet |
|
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 randomised parellel group active controlled study to evaluate the add on effect of Jatamansi ( Nordostachys jata mansi) fant with conventional post covid protocol in post covid anxiety
Assesement criteria-
Primary outcome measures will be -
Objective criteria - Hamilton’s Anxiety Rating Scale ( HAM-A) Follow up on - 7th , 14th, 21th and 28th day will be taken
Subjective criteria - Personal relief in symptoms like Hridgrah, Ucchavasadhikya , Anidra , unmattachittatva, etc Follow up on 7th , 14th, 21th and 28th day will be taken
Secondary outcome measurement - improvement in life of patients, improvement in kanti, weight hain, etc |