| CTRI Number |
CTRI/2025/03/082152 [Registered on: 11/03/2025] Trial Registered Prospectively |
| Last Modified On: |
10/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Ayurvedic Medicine in Anxiety |
|
Scientific Title of Study
|
Randomized Controlled Trail Of Jivaniya Gan Dravya Vati In Ojakshaya With Special Reference To Generalised 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 |
Meerabai Tatyarao |
| Designation |
PG scholar |
| Affiliation |
Siddhakala Ayurved mahavidyalaya ,sangamner |
| Address |
OPD number 1, Kayachikitsa department,Siddhakala Ayurved mahavidyalaya, Pimparne road ,sangamner Ahemdnagar, Maharashtra,422605
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
7020484805 |
| Fax |
|
| Email |
lambemeera108@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Omkar Vinayak Kortikar |
| Designation |
HOD of Department of Kayachikitsa |
| Affiliation |
Siddhakala Ayurved Mahavidyalaya, Sangamner |
| Address |
Kayachikitsa department Siddhakala Ayurveda mahavidyalaya,Pimparne Road,sangamner
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9850218004 |
| Fax |
|
| Email |
omkar_kortikar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd Omkar Vinayak Kortikar |
| Designation |
HOD of Department of Kayachikitsa |
| Affiliation |
Siddhakala Ayurved Mahavidyalaya, Sangamner |
| Address |
Kayachikitsa department Siddhakala Ayurveda mahavidyalaya,Pimparne Road,sangamner
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9850218004 |
| Fax |
|
| Email |
omkar_kortikar@yahoo.com |
|
|
Source of Monetary or Material Support
|
| siddhakala ayurved mahavidyalay,Pimparne road,sangamner Khurd,Sangamner,Ahilyanagar,Maharashtra,422605 |
|
|
Primary Sponsor
|
| Name |
Meerabai Tatyarao |
| Address |
Siddhakala ayurved mahavidyalay,Pimparne road ,Sangamner khurd,Sangamner,Ahamadnagar,Maharashtra,India.Pincode-422605 |
| 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 Meerabai Tatyarao |
Siddhakala ayurved Mahavidyalaya, sangamner |
OPD number 1, Kayachikitsa department, Siddhakala Ayurved
mahavidyalaya, Pimparne road , sangamnner Ahmadnagar, MAHARASHTRA
Ahmadnagar
MAHARASHTRA |
7020484805
lambemeera108@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Board of Ayurved Research and Statistics Committee of Siddhakala Ayurved Mahavidyalaya,Sangamner |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F411||Generalized anxiety disorder. Ayurveda Condition: OJAKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Jivaniya Gan Dravya Vati, Reference: Ashtanga Hridaya Samhita,Sutra Sthan, ,Chapter number 11,Shloka number 41, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Godugdha), Additional Information: -Aushadh Sevan Kaala-VyanoUdan Kala,Anupaan Matra 5 to 10 ml | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Jatamansi Vati , Reference: Bhavprakash Nighantu, Karpuradi Varga, Jatamansi , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Koshna Jal), Additional Information: -Aushadha Sevan Kala - Vyanoudana |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients up to Moderate level of Anxiety below 14 points on GAD 7 Scales,Patient having lakshnas of Ojakshaya. |
|
| ExclusionCriteria |
| Details |
Patient taking psychotropic drugs four weeks prior to study,Substance abuse like Alcohol,Pregnant and Lactating Mothers,Patients with Ischemic Heart Disease,Hypertension,Myocardial Infarction,Cerebrovascular event,Cardiac arrythmias,Diabetes and active Malignant disease. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of Oral administration of 500 mg Jivaniya Gan Dravya Vati twice a day with Godugdha 5 to 10 ml for 30 days in managment of Ojakshay with special reference to Generalised Anxiety Disorder Based on diffrence in Parameters of GAD 7 scale and DSM v criteria assessed before and after treatment |
10 th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To conceptually study the Ojakshya & its management by relevant ancient methodology.
To observe the adverse effect of Jivaniya Gan Dravya Vati in Ojakshaya if any.
To asses any correlation between Oja & Generalised Anxiety Disorder 10 Edit || Delete
|
10 th day |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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)
|
03/04/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This study is Randomized Open labelled Controlled Clinical Trail Comparing The Safety and Efficacy Of Jivaniya Gan Dravya Vati 500 mg and Controlled Drug Jatamansi Vati 500 mg for 30 days in 74 patient With Generalised Anxiety Disorder and effect on Generalised Anxiety Disorder 7 Scale . |