| CTRI Number |
CTRI/2021/09/036359 [Registered on: 09/09/2021] Trial Registered Prospectively |
| Last Modified On: |
08/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
A Comparative Clinical trial to study the effect of Takradhara and Shiro-abhyang with Yashtimadhuadya Tail in the management of Generalized Anxiety Disorder |
|
Scientific Title of Study
|
A Comparative Clinical study of Takradhara and Shiro-abhyang with Yashtimadhuadya Tail in the management of Chittodvega (Generalized Anxiety Disorder) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Swati Parmar |
| Designation |
Post graduation scholar |
| Affiliation |
shubhdeep ayurved medical college |
| Address |
Panchkarma opd shubhdeep ayurved medical college datoda indore
Panchkarma opd shubhdeep ayurved medical college datoda indore
Indore
MADHYA PRADESH
456010
India |
| Phone |
8878444476 |
| Fax |
|
| Email |
drswati.parmar123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Monika das |
| Designation |
Associate professor |
| Affiliation |
Shubhdeep ayurved medical college |
| Address |
Panchkarma opd shubhdeep ayurved medical college
indore
shubhdeep ayurved medical college datoda indore
Indore
MADHYA PRADESH
452020
India |
| Phone |
9425320769 |
| Fax |
|
| Email |
dasmonika16@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Monika das |
| Designation |
Associate professor |
| Affiliation |
Shubhdeep ayurved medical college |
| Address |
Panchkarma opd shubhdeep ayurved medical college
indore
shubhdeep ayurved medical college datoda indore
Indore
MADHYA PRADESH
452020
India |
| Phone |
9425320769 |
| Fax |
|
| Email |
dasmonika16@gmail.com |
|
|
Source of Monetary or Material Support
|
| shubhdeep ayurved medical college datoda indore mp pincode 452020 |
|
|
Primary Sponsor
|
| Name |
shubhdeep ayurved medical college |
| Address |
shubhdeep ayurved medical college datoda indore |
| Type of Sponsor |
Private medical college |
|
|
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 Swati Parmar |
Shubhdeep Ayurved Medical College |
Panchkarma OPD, Shubhdeep Ayurved Medical College, datoda, Khandwa road, indore 452020
Indore
MADHYA PRADESH |
8878444476
drswati.parmar123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitee Shubhdeep Ayurved Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F411||Generalized anxiety disorder. Ayurveda Condition: chittodvega, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
takradhara in chittodvega |
1 takradhara in chittodvega for 7 days
2 shiro-abhyang with yashtimadhuadhya tail for 7 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1 DSM-IV
2 patients with anxiety from last 6 months |
|
| ExclusionCriteria |
| Details |
1 patients above 70 and below 20 years of age
2 patients with any severe systemic illness |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in classical sign and symptoms of chittodvega (At the time of baseline and at the end of the treatment) |
Total study period 12 months and treatment period 3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of change in the clinical parameters |
Total study period 12 months and Treatment period 3 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
13/09/2021 |
| 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
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study of randomized interventional comparative clinical study of takradhara and shiro-abhyang with yashtimadhuadhya tail in chittodvega (generalized anxiety disorder). Total 60 patients will be enrolled in present study. Selected patients will be divided into two groups on the basis of computer generated randomization.
GROUP A 30 patients will be given takradhara for 7 days
GROUP B 30 patients will be given shiro-abhyang with yashtimadhuadhya tail |