| CTRI Number |
CTRI/2025/04/085692 [Registered on: 25/04/2025] Trial Registered Prospectively |
| Last Modified On: |
25/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Screening |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
EFFICACY OF BRAHMI VATI AND ASHWAGANDHARISHTA IN
Generalized anxiety disorder |
|
Scientific Title of Study
|
Efficacy of brahmi vati and ashwagandharishta in (chittodwega) generalized anxiety disorder- Randomized controlled clinical trail |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anjali punia |
| Designation |
Phd scholar |
| Affiliation |
desh bhagat university |
| Address |
nh-44 amloh road mandi gobindgarh district fatehgarh sahib punjab-14,
nh-44 amloh road mandi gobindgarh district fatehgarh sahib punjab-14,
Fatehgarh Sahib
PUNJAB
147301
India |
| Phone |
7355551296 |
| Fax |
7355551296 |
| Email |
anjali.punia1991@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr RAKESH PAWAR |
| Designation |
professor department of kayachikitsa |
| Affiliation |
|
| Address |
nh-44 amloh road mandi gobindgarh district fatehgarh sahib punjab-14
nh-44 amloh road mandi gobindgarh district fatehgarh sahib punjab-14
Fatehgarh Sahib
PUNJAB
147301
India |
| Phone |
7505039976 |
| Fax |
7505039976 |
| Email |
anjali.punia1991@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr RAKESH PAWAR |
| Designation |
phd guide in kayachikitsa depatment |
| Affiliation |
desh bhagat university |
| Address |
nh-44 amloh road mandi gobindgarh district fatehgarh sahib punjab-14,
nh-44 amloh road mandi gobindgarh district fatehgarh sahib punjab-14,
Fatehgarh Sahib
PUNJAB
147301
India |
| Phone |
7505039976 |
| Fax |
|
| Email |
drpawar3757@gmail.com |
|
|
Source of Monetary or Material Support
|
| desh bhagat university mandi gobindgarh punjab 147301 |
|
|
Primary Sponsor
|
| Name |
Dr anjali punia |
| Address |
desh bhagat university |
| 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 |
| anjali punia |
iimt university |
nh-44 amloh road mandi gobindgarh district fatehgarh sahib punjab-14,
Fatehgarh Sahib
PUNJAB |
7355551296
anjali.punia1991@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| university ethics committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F411||Generalized anxiety disorder. Ayurveda Condition: CINTAJANYA-AROCAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: brahmi vati,, Reference: Sharangadhara Samhita, Madhyam Khanda, 9/198, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -water), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: ashwagandharishta, Reference: Bhaishjya Ratnavali Murcha Rogadhikara, 13,17, AFI Part-1,, Route: Oral, Dosage Form: Arishta, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients fulfilling the HAM-A Scale and QOL (Quality of Life) Assessment Criteria for
Generalized Anxiety Disorder.
2. Age group between 16-60 years |
|
| ExclusionCriteria |
| Details |
EXCLUSION CRITERIA [19]
1. Patients presenting with Major Organic Disorders and Psychotic Disorders
2. Patients below 16 years of age and above 60 years
3. Patients suffering from any other serious illness
4. Alcoholic, and self-harm or suicide risk.
5. Diagnosed with psychosis, schizophrenia, or bipolar illness currently or in the past.
6. Treatment with sertraline for two or more weeks within the previous three months.
7. Pregnant and lactating mothers. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in the Hamilton Anxiety Scale score, WHO- Quality of Life, |
0, 30, 60 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| not applicable |
not applicable |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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
|
N/A |
|
Date of First Enrollment (India)
|
12/05/2025 |
| 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="2"
Months="0"
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 - NO
|
|
Brief Summary
|
anxiety is normal and common process of stress.it is beneficial at time and harmful of health at time. on the beneficial side, anxiety alerts certain dangers and dangerous situation. which we might tentatively confront and helps us to prepare and pay attention to it. anxiety disorders are the most common of mental disorders .they affect approximately 30% of adults at some part of their lives. these disorders are harmful for our heath . they differ from normal feelings of anxiousness and nervous ness . they involve excessive fear and anxiety . at the same time ,these disorders can be treated as there are many treatment options to deal with them .women are likely to experience these disorders more than man
|