| CTRI Number |
CTRI/2017/09/009774 [Registered on: 14/09/2017] Trial Registered Retrospectively |
| Last Modified On: |
19/07/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of ALERT Capsule in Generalized Anxiety Disorder |
|
Scientific Title of Study
|
Efficacy and Safety of ALERT Capsule in the Managment of Generalized Anxiety Disorder-An Open Label Clinical Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BMK/15/BRT/01 , Version-4, Date-6.10.2015 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Basavaraj R Tubaki |
| Designation |
Professor and Head |
| Affiliation |
KLEU BMK Ayurveda Mahavidyalaya |
| Address |
Dept of Kayachikitsa
KLEU BMK Ayurveda Mahavidyalaya Shahapur
Belgaum
Belgaum
KARNATAKA
590003
India |
| Phone |
09448634660 |
| Fax |
08312424157 |
| Email |
ayurbasavaraj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Basavaraj R Tubaki |
| Designation |
Professor and Head |
| Affiliation |
KLEU BMK Ayurveda Mahavidyalaya |
| Address |
Dept of Kayachikitsa
KLEU BMK Ayurveda Mahavidyalaya Shahapur
Belgaum
Belgaum
KARNATAKA
590003
India |
| Phone |
09448634660 |
| Fax |
08312424157 |
| Email |
ayurbasavaraj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Basavaraj R Tubaki |
| Designation |
Professor and Head |
| Affiliation |
KLEU BMK Ayurveda Mahavidyalaya |
| Address |
Dept of Kayachikitsa
KLEU BMK Ayurveda Mahavidyalaya Shahapur
Belgaum
Belgaum
KARNATAKA
590003
India |
| Phone |
09448634660 |
| Fax |
08312424157 |
| Email |
ayurbasavaraj@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vasu Research Centre [VRC]
(A Division of VASU Health Care Pvt. Ltd.)
896/A, G.I.D.C., Makarpura, Vadodara- 390010
|
|
|
Primary Sponsor
|
| Name |
Vasu Research Centre VRC A Division of VASU Health Care Pvt Ltd |
| Address |
896/A G.I.D.C. Makarpura Vadodara- 390010 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 B R Tubaki |
KLE Ayurveda Hospital |
Manasollasa Center, Room No.13,KLE Ayurveda Hospital,
KLEU BMK Ayurveda Mahavidyalaya, Shahapur
Belgaum
KARNATAKA |
08312424157
ayurbasavaraj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Research on Human Subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Generalized Anxiety Disorder (GAD)as per DSM V criteria, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ALERT Capsules |
It contains Celastrus paniculatus (Jyotishmati) Seed oil, and Cow Ghee, processed with Acorus calamus (Vaj) Rhizome, Convolvulus pluricaulis (Shankhapushpi) Whole plant,Nardostachys jatamansi (Jatamansi) Rhizome, and Eclipta alba (Bhringraj) Whole plant. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
60.00 Day(s) |
| Gender |
Both |
| Details |
(1) Patients (Male & Female) between the age group of 18 and 60 years and willing to give consent to participate in the study.
(2) Patients having Generalized Anxiety Disorder 7 (GAD-7) score ≥ 10
(3) Patients having Hamilton Anxiety Rating Score (HAM-A) ≥ 11
(4) Patients suffering from psycho- physiological insomnia especially due to anxiety.
|
|
| ExclusionCriteria |
| Details |
(1) Patients below 18 years and above 60 years
(2) Patients with Hamilton Depression Rating Scale score >13
(3) Patients suffering from any serious liver, kidney and cardiac diseases.
(4) Patients having history of any genetic disorders
(5) Patients on hypnotic medicine or other drugs which known to cause drowsiness.
(6) Lactating & pregnant women
(7) Patients on any Psychotropic or Nuerotrophic drugs 4 weeks prior to the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcomes will be effect of drug on subjective and objective parameters |
baseline, 15th, 30th, 45th & 60th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of drug safety and patient’s compliance |
base line, 15th day, 30th day, 45th day, 60th day |
|
|
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)
|
04/04/2016 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Generalized anxiety disorder (GAD) is characterized by excessive,
uncontrolled and often irrational worry, that is, apprehensive expectation
about events or activities. In India, around 6-10% population is suffering from
GAD. Anxiolytic drugs are extremely tempting, and prescribed to millions of individuals
suffering from anxiety and stress. But some of them (like Benzodiazepines,
Buspirone) are known to produce side effects like hypotension, nausea, memory
loss, sexual dysfunction, headache etc. Thus, it needs to
search for safe and effective solution. The
present study is to be initiated for evaluating clinical efficacy and safety of
Alert Capsule in the management of Generalized Anxiety Disorder (GAD). Disease
specific inclusion and exclusion criteria have been selected and shall
be employed for the enrolment of patients. For the assessment of efficacy
appropriate subjective parameters like Generalized Anxiety Disorder 7 (GAD-7)
scale, Hamilton Anxiety Rating Scale (HAM-A), Hamilton Depression Rating Scale
(HAM-D), WHO Quality of life BREF, Pittsburg sleep quality index, Clinical
global Impression will be used. On another hand, bio-chemical parameter like
serum cortisol level will be analysed as anxiety marker other investigations
like liver Function test, Renal Function test, Complete blood profile like Hb,
ESR, RBC, PCV, MCV, MCH, MCHC, WBC, WBC Differential, total platelet count, MPV
and blood clotting time will be evaluated. Urine & Stool routine
examination will also be carried out. Total study period in a patient will be of 60
days. Treatment with test drug will be provided for 1 month and followed by 1
month period of placebo interventional observation period. Follow-up visit is
to be scheduled at every 2 weeks of interval with 4 follow up. All the
laboratory investigations will be carried out at base line and 30th day.
However evaluation with all the clinical assessment scales will be carried out
at all the visits. Appropriate statistics
tools shall be applied to find out statistical significance of undergoing
therapy. |