| CTRI Number |
CTRI/2017/07/009095 [Registered on: 21/07/2017] Trial Registered Retrospectively |
| Last Modified On: |
01/08/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of Aswagandha and Mandookaparni in Manodwega (GAD) patients |
|
Scientific Title of Study
|
Clinical evaluation of A comprehensive Ayurvedic intervention in Manodwega (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 |
Dr G V Ramana |
| Designation |
Research officer (Ay) Scientist 2 |
| Affiliation |
Advanced centre for Ayurveda in Mental health & Neurosciences |
| Address |
Advanced centre for Ayurveda in Mental health & Neurosciences, NIMHANS campus, Hosur road, Bangalore
Bangalore
KARNATAKA
560029
India |
| Phone |
08026995243 |
| Fax |
08026567546 |
| Email |
gvr1528@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr D Sudhakar |
| Designation |
Asst Director (AY)SC3 |
| Affiliation |
Advanced centre for Ayurveda in Mental health & Neurosciences |
| Address |
Advanced centre for Ayurveda in Mental health & Neurosciences, NIMHANS campus, Hosur road, Bangalore
Bangalore
KARNATAKA
560029
India |
| Phone |
08026567546 |
| Fax |
08026567546 |
| Email |
acamhns.bengaluru@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr D Sudhakar |
| Designation |
Asst Director (AY)SC3 |
| Affiliation |
Advanced centre for Ayurveda in Mental health & Neurosciences |
| Address |
Advanced centre for Ayurveda in Mental health & Neurosciences, NIMHANS campus, Hosur road, Bangalore
Bangalore
KARNATAKA
560029
India |
| Phone |
08026567546 |
| Fax |
08026567546 |
| Email |
acamhns.bengaluru@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central council for Research in Ayurvedic sciences, New Delhi
Ministry of AYUSH, Govt of India |
|
|
Primary Sponsor
|
| Name |
Central council for Research in Ayurvedic sciences |
| Address |
No 61 to 65 Institutional area Opp D block Janakpuri New delhi |
| Type of Sponsor |
Government funding agency |
|
|
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 G V Ramana |
Advanced centre for Ayurveda in mental health and neuro sciences |
NIMHANS campus Bangalore
Room no -03
Bangalore
KARNATAKA |
08026995243
08026567546
acamhns.bengaluru@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| centers ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Diagnosed cases of Generalized Anxiety Disorder based on DSM IV criteria, (1) ICD-10 Condition: F411||Generalized anxiety disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
GROUP I |
Group I:
1. Ashvagandha churna (Bhava prakasha nighantu). In tablet form.
Dose 1.5 gm (3 tablets of 500 mg each) twice daily
Dosage form Tablet
Route of Administration Oral
Time of Administration Twice a day after food
Anupana Luke warm water
Duration of therapy 12 weeks
2. Mandookaparni churna (Bhava prakasha nighantu). In tablet form.
Dose 1.5 gm (3 tablets of 500 mg each) twice daily
Dosage form Tablet
Route of Administration Oral
Time of Administration Twice a day after food
Anupana Luke warm water
Duration of therapy 12 weeks
|
| Comparator Agent |
GROUP II |
1. Ashvagandha churna (Bhava prakasha nighantu). In tablet form.
Dose 1.5 gm (3 tablets of 500 mg each) twice daily
Dosage form Tablet
Route of Administration Oral
Time of Administration Twice a day after food
Anupana Luke warm water
Duration of therapy 12 weeks
2. Mandookaparni churna (Bhava prakasha nighantu). In tablet form.
Dose 1.5 gm (3 tablets of 500 mg each) twice daily
Dosage form Tablet
Route of Administration Oral
Time of Administration Twice a day after food
Anupana Luke warm water
Duration of therapy 12 weeks
3. Shirodhara with Ksheerbala taila (Sahasrayoga taila prakaran) for 30 minutes daily for initial seven days along with above medication.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Age between 18 to 45 years of either sex
2. Diagnosed Cases of GAD Based on DSM IV diagnostic criteria for Generalized Anxiety Disorder
3. Willing to give written informed consent for the participation.
|
|
| ExclusionCriteria |
| Details |
1. Age less than 18 years and more than 45 years.
2. Depression
3. Social phobias
4. Hypertension
5. Cardiac diseases
6. Epilepsy
7. Asthma and COPD
8. Hyperthyroidism
9. Diabetes
10. Alcoholics and Drug addicts
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary Outcome Measure
To assess improvement in total Hamilton anxiety rating scale
|
Periodically once in 4 weeks till 12 weeks duration |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary Outcome Measure
To observe change in individual components of Hamilton anxiety rating scale
|
At the end of study period of 3 years |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
12/09/2013 |
| Date of Study Completion (India) |
16/12/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
no |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized parallel group clinical trial assessing the efficacy of Ashwagandha (Withania Somnifera) and Mandukaparni (Bacopa Monerii) in 3gm dose per day (1.5gm BID) in group I, and along with these medicines Shirodhara (Pouring of medicated herbal oil on the forehead for 30 minutes ) with Ksheerabala taila in Group II. The intervention period for internal medicines is 12 weeks in both the groups and Shirodhara in Group II will be during first 7 days. The study centre is Advanced centre for Ayurveda in Mental health and neurosciences, NIMHANS campus Bangalore. The primary objective is assessment of the safety and efficacy of intervention in terms of changes in HRS for Anxiety in Manodwega (GAD patients).
Shirodhara is an Ayurvedic treatment procedure in which medicated oils are poured in a stream on the fore head for a period of 30 minutes. It is having effects like improving concentration, induces sleep and has a tranquilizing effect.
|