| CTRI Number |
CTRI/2024/05/067179 [Registered on: 10/05/2024] Trial Registered Prospectively |
| Last Modified On: |
25/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study management of ayurvedic formulation in generalized anxiety disorder. |
|
Scientific Title of Study
|
A single arm clinical study to evaluate the efficacy of an ayurvedic formulation in the management of Generalized Anxiety Disorder.
|
| 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 Nilang Rajnikant Bhimani |
| Designation |
MD Scholar Kayachikitsa |
| Affiliation |
Dr. D. Y. Patil college of Ayurveda and Research center |
| Address |
Kayachikitsa Department,OPD no. 15
Dr.D.Y.Patil College of Ayurveda and Research centre Sant tukaram
nagar, pimpri, pune
Pune
MAHARASHTRA
411018
India
Pune
MAHARASHTRA
411018
India |
| Phone |
9825621176 |
| Fax |
|
| Email |
nilang.patel99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhijit D Shekhar |
| Designation |
M.D. (Kayachikitsa) |
| Affiliation |
Dr. D. Y. Patil college of Ayurveda and Research center |
| Address |
Kayachikitsa Department,OPD no. 15
Dr.D.Y.Patil College of Ayurveda and Research centre Sant tukaram
nagar, pimpri, pune
Pune
MAHARASHTRA
411018
India
Pune
MAHARASHTRA
411018
India |
| Phone |
9764546495 |
| Fax |
|
| Email |
abhijit.shekhar@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhijit D Shekhar |
| Designation |
M.D. (Kayachikitsa) |
| Affiliation |
Dr. D. Y. Patil college of Ayurveda and Research center |
| Address |
Kayachikitsa Department,OPD no. 15
Dr.D.Y.Patil College of Ayurveda and Research centre Sant tukaram
nagar, pimpri, pune
Pune
MAHARASHTRA
411018
India
Pune
MAHARASHTRA
411018
India |
| Phone |
9764546495 |
| Fax |
|
| Email |
abhijit.shekhar@dpu.edu.in |
|
|
Source of Monetary or Material Support
|
| Dr.D.Y.Patil College of Ayurveda and Research centre Sant tukaram nagar, pimpri, pune |
|
|
Primary Sponsor
|
| Name |
Dr. Nilang Rajnikant Bhimani |
| Address |
Dr.D.Y.Patil College of Ayurveda and Research centre Sant tukaram
nagar, pimpri, 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 Nilang Rajnikant Bhimani |
Dr.D.Y.Patil College of Ayurveda and Research centre |
Kayachikitsa Department,OPD no. 15
Dr.D.Y.Patil College of
Ayurveda and
Research centre Sant
tukaram nagar, pimpri,
pune 411018
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
9825621176
nilang.patel99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR. DYPCA & RC INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F411||Generalized anxiety disorder. Ayurveda Condition: MANOVAHASROTOVIKARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Brahmi, Sankhpushpi, Jatamansi, Haritaki, Usira, Parushaka, Gorakhmundi, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Ghrut), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients fulfilling the diagnostic criteria for the Anxiety Disorders as per DSM 5
Age group - between 18 years to 70 years.
Voluntarily participation in the clinical trial and agreeing to follow study procedures
Not participating in any other interventional drug clinical studies before completion of the present study.
|
|
| ExclusionCriteria |
| Details |
Inability to intake or tolerate oral medications
Pregnant or lactating women
Patients with current or has a history of substance use disorder
Patients having severe renal or hepatic impairment
Patients who displayed marked suicidal intent or known suicidal tendencies
Patient suffering from any psychiatric disorder other than GAD.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in generalised anxiety disorder symptoms
Improvement in hamilton anxiety rating scale |
28 days study with 2 follow up (14 day and 28
day) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
assess improvement in sleep through Insomnia Severity Index.
assess improvement in Quality of Life through ‘Quality of Life Enjoyment and Satisfaction Questionnaire’ (Q-LES-Q).
|
28 days study with 2 follow up (14 day and 28
day) |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "35"
Final Enrollment numbers achieved (India)="35" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
27/05/2024 |
| Date of Study Completion (India) |
10/09/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
To study the efficacy of ayurvedic formulation in the management of generalized anxiety disorder (chittodvega) and total 30 patients will be enrolled and ayurvedic formulation of 500mg 2 vati in morning and evening will be given after food with ghee for duration of 28 days and follow up will be done on 14th and 28th day and final conclusion will be drawn on the basis of statistical methods. |