| CTRI Number |
CTRI/2025/01/079152 [Registered on: 21/01/2025] Trial Registered Prospectively |
| Last Modified On: |
11/12/2024 |
| 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
|
Clinical study on Psychopharmacological therapeutic efficacy of Vidarikand in Management of Chittodwega (GAD) |
|
Scientific Title of Study
|
Clinical study on Psychopharmacological therapeutic efficacy of Vidarikand (Pueraria tuberosa Roxb. ex Willd) in the Management of Chittodwega (Generalized Anxiety Disorder) - An Open Randomized Controlled Clinical trial |
| 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 Anushka Motwani |
| Designation |
PG Scholar (Dravyaguna Vigyan) |
| Affiliation |
D.Y. Patil School of Ayurveda |
| Address |
Department of Dravyaguna Vigyan, OPD no.1,
D.Y. Patil School of Ayurveda Deemed to be University, Nerul, Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9145465410 |
| Fax |
|
| Email |
anushkamotwani29@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Charushila Giri |
| Designation |
Professor and HOD |
| Affiliation |
D.Y. Patil School of Ayurveda |
| Address |
Department of Dravyaguna Vigyan, OPD no.1,
D.Y. Patil School of Ayurveda Deemed to be University, Nerul, Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9892356496 |
| Fax |
|
| Email |
charushila.giri@dypatil.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Charushila Giri |
| Designation |
Professor and HOD |
| Affiliation |
D.Y. Patil School of Ayurveda |
| Address |
Department of Dravyaguna Vigyan, OPD no.1,
D.Y. Patil School of Ayurveda Deemed to be University, Nerul, Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9892356496 |
| Fax |
|
| Email |
charushila.giri@dypatil.edu |
|
|
Source of Monetary or Material Support
|
| D.Y. Patil Deemed to be University School of Ayurveda, Nerul, Navi Mumbai-400706, India |
|
|
Primary Sponsor
|
| Name |
D.Y. Patil School of Ayurveda Deemed to be University, Nerul, Navi Mumbai |
| Address |
D.Y. Patil School of Ayurveda Deemed to be University, Nerul, Navi Mumbai
Thane district, India
400706 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Charushila Giri |
D.Y. Patil School of Ayurveda |
Department of Dravyaguna Vigyan, OPD no.1,
D.Y. Patil School of Ayurveda Deemed to be University, Nerul, Navi Mumbai
Thane
MAHARASHTRA |
9892356496
charushila.giri@dypatil.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC of D.Y. Patil Deemed to be University, School of Ayurveda, Nerul |
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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Ashwagandha , Reference: Research article, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Koshna jala), Additional Information: Nil | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vidarikand , Reference: Su.Apasmar.Chi, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Koshna jala), Additional Information: Nil |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
39.00 Year(s) |
| Gender |
Both |
| Details |
Patients having cardinal symptoms of GAD for more than 6 months |
|
| ExclusionCriteria |
| Details |
Patients below 18 and above 39 years
Patients with other ADs like OCD, BPD, phobias etc.
Pregnant and lactating women
Immunocompromised patients
Patients with Substance abuse disorders |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in Anxiety symptoms, as measured by HAM-A, DASS 21, AAA Scale over the course of intervention |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in Anxiety and its symptoms |
60 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 3 |
|
Date of First Enrollment (India)
|
01/02/2025 |
| 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="1"
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
|
Chittodwega is a psychological disorder which can be defined as an ’anxious state of mind.’ Generalized Anxiety disorder’ is an anxiety disorder characterized by anxiety and worry that is not associated with a particular object, situation or event but seems to be a constant feature of a person’s day to day life, along with physical symptoms of stress lasting a period of 6 months. Impact of GAD on quality of life : Excessive concern, restlessness, difficulty sleeping, tiredness, irritability, sweating, trembling etc. interfere with work, relationships and other parts of life, suicidal thoughts, if untreated may lead to major psychological disorders (psychosis, schizophrenia) GAD is under detected due to fear and shyness. It has high prevalence rates, poor quality of life, difficulties in detection, treatment, tendency to be chronic and associated with comorbidities. Even then it remains least studied. Treatment gap : 70-80 % Problems in conventional treatments : SSRIs have various side effects ( Nausea, Drowsiness, Insomnia, habit forming, sedating, sexual problems, agitation etc.) Need for safer treatment : All these limitations are encouraging the patients to explore for possible therapies in complementary and alternative systems of medicine. Ayurveda is a great treasure of precious concepts like Rasayana (Rejuvenation therapy) which can be very well utilized to combat with this burning issue. In Sushrut Apasmar Chikitsa, use of Vidaryadi gana and Kakolyadi gana have been mentioned which is a direct reference for use of Vidarikand (Su.Uttarsthana.61.29) for our present study of Manas vikar. Besides, Puerarin an active constituent of vidari has already been proven as an anxiolytic, neurotonic. With present study we hope to explore the role of Vidarikand in Chittodwega.
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