| CTRI Number |
CTRI/2025/02/080808 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
07/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the effect of vruddhadaru (Argyriea speciosa Linn.)on anxiety |
|
Scientific Title of Study
|
Randomized controlled clinical study to evaluate the efficacy of vruddhadaru churna in treatment of generalized anxiety disorder in geriatric age group. |
| 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 Pallavi Gajanan Chincholkar |
| Designation |
PG Scholar |
| Affiliation |
Tilak Ayurved Mahavidyalaya, Pune |
| Address |
Dravyaguna department, Tilak Ayurved Mahavidyalaya, Rasta peth, Pune
Dravyaguna department, Tilak Ayurved Mahavidyalaya, Rasta peth, Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
8805606053 |
| Fax |
|
| Email |
pchincholkar7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Asmita Uday Jadhav |
| Designation |
PG Guide |
| Affiliation |
Tilak Ayurved Mahavidyalaya, Pune |
| Address |
Dravyaguna department, Tilak Ayurved Mahavidyalaya, Rasta peth, Pune
Dravyaguna department, Tilak Ayurved Mahavidyalaya, Rasta peth, Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
9359772607 |
| Fax |
|
| Email |
asmita.niramaya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Asmita Uday Jadhav |
| Designation |
PG Guide |
| Affiliation |
Tilak Ayurved Mahavidyalaya, Pune |
| Address |
Dravyaguna department, Tilak Ayurved Mahavidyalaya, Rasta peth, Pune
Dravyaguna department, Tilak Ayurved Mahavidyalaya, Rasta peth, Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
9359772607 |
| Fax |
|
| Email |
asmita.niramaya@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Pallavi Gajanan Chincholkar |
| Address |
Tilak Ayurved Mahavidyalaya and Seth Tarachand Ramnath charitable Ayurved hospital Rasta Peth, Pune |
| 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 Pallavi Gajanan Chincholkar |
Tilak Ayurved Mahavidyalaya and Seth Tarachand Ramnath charitable Ayurved hospital |
Seth Tarachand
Ramnath charitable
Ayurved hospital OPD no 27, 4 th floor,
583/2 Rasta peth, pune
411011, Maharashtra,
India
Pune
MAHARASHTRA |
8805606053
pchincholkar7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Tilak Ayurved Mahavidyalaya and Seth Tarachand Ramnath charitable Ayurved hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F411||Generalized anxiety disorder. Ayurveda Condition: CITTAVIBRAMA-SANNIPATAJAJVARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vruddhadaru churna, Reference: Bhavprakash Nighantu Guduchyadi Varga 211, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
patients suffering from symptoms of genralized anxiety disorder such as fatigue, mental confusion , worry, sleep disturbances, restlessness lower level of cognitive ad somatic distress, panic disorder, more dizziness and faintness |
|
| ExclusionCriteria |
| Details |
Serious illness such as cancer kidney disease and heart disease
known case of mental retardation or having any other psychological disorders |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| reduction in symptoms of generalised anxiety disorder |
45 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
increase quality of life
sound sleep |
45 days |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
25/02/2025 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - Nil
- For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Present study is based on understanding the effect of Vruddhadaru churna in Generalised Anxiety Disorder in geraiatic patients suffering from fatigue, mental confusion, sleep disturbances, restlessness, lower level of cognitive and somatic distress and panic disorders. current study will include 50 patients which will be divided into two groups for better understanding. study will be of 45 days with 30 days of intervention with 1gm of Vruddhadaru churna with jala in patients of Group A. Group B will be treated with conventional Protocol of Anxiety. Folllowup will be taken after 15 days of intervention. It is expected to have reduction in the above mentioned symptoms with the 30 days intervention |