| CTRI Number |
CTRI/2024/07/070479 [Registered on: 11/07/2024] Trial Registered Prospectively |
| Last Modified On: |
11/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study To Evaluate Role of Brahmyadi churna and Ashvagandha churna with Satwavjaya chikitsa in Anxiety. |
|
Scientific Title of Study
|
A Randomized open labelled comparative clinical study to evaluate the combined efficacy of Brahmyadi churna and Asvagandha churna with Satwavjaya chikitsa in the management of Chittodvega 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 |
Dr Anupam |
| Designation |
PG Scholor |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research Hospital, Bangalore |
| Address |
OPD No. 5 Dept of PG Studies in Kayachikitsa Sri Sri College of
Ayurvedic Science and Research Hospital 21st Km Kanakpura Rd
Udayapura PO OB Chudahalli Bangalore
Bangalore
KARNATAKA
560082
India
Near art of living ashram
Bangalore
KARNATAKA
560082
India |
| Phone |
08076370183 |
| Fax |
|
| Email |
soroutanupam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gopalakrishna G |
| Designation |
Professor and Head of Department |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research Hospital, Bangalore |
| Address |
OPD No. 5 Dept of PG Studies in Kayachikitsa Sri Sri College of
Ayurvedic Science and Research Hospital 21st Km Kanakpura Rd
Udayapura PO OB Chudahalli Bangalore
Bangalore
KARNATAKA
560082
India
Bangalore
KARNATAKA
560082
India |
| Phone |
08076370183 |
| Fax |
|
| Email |
lakshmimp1981@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gopalakrishna G |
| Designation |
Professor and Head of Department |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research Hospital, Bangalore |
| Address |
OPD No. 5 Dept of PG Studies in Kayachikitsa Sri Sri College of
Ayurvedic Science and Research Hospital 21st Km Kanakpura Rd
Udayapura PO OB Chudahalli Bangalore
Bangalore
KARNATAKA
560082
India
Bangalore
KARNATAKA
560082
India |
| Phone |
08076370183 |
| Fax |
|
| Email |
lakshmimp1981@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Sri College of Ayurvedic Science and Research Hospital, Bangalore,560082,India |
|
|
Primary Sponsor
|
| Name |
Dr Anupam |
| Address |
OPD No. 5 Dept of PG Studies in Kayachitsa Sri Sri College of
Ayurvedic Science and Research Hospital 21st Km Kanakpura Rd
Udayapura PO OB Chudahalli Bangalore |
| Type of Sponsor |
Other [[Self]] |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anupam |
Sri Sri College of Ayurvedic Science and Research Hospital |
OPD No. 5, Department of PG Studies in Kayachikitsa ,21st KM Kanakapura Road Udaypura post, Bengaluru, Karnataka.
KARNATAKA
Bangalore
KARNATAKA |
8076370183
soroutanupam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Sri Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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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 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Brahmyadi churna , Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: -Honey), Additional Information: -Brahmyadi churna with Satwavajaya chikitsa. | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Ashwagandha churna, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: -Honey), Additional Information: -Ashwagandha Churna with Satwavajaya Chikitsa |
|
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects fulfilling criteria based on DSM-5 and those getting score between 8-23 in Hamilton Anxiety Rating Scale will be included in the study.
2.Subjects suffering from GAD for a minimum period of atleast 6 months
3.Subjects between age group of 20 to 60 years irrespective of gender.
4.Subjects willing to sign consent form.
|
|
| ExclusionCriteria |
| Details |
1.Subjects on use of anxiolytics or antidepressants in the previous 6 months.
2.Subjects diagnosed with other psychiatric illnesses like mood disorder, psychosis, depression etc. from past 12 months.
3.Subjects suffering from Generalised anxiety disorder associated with other serious systemic illnesses that would interfere with the treatment.
4.Subjects with uncontrolled hypertension , diabetes mellitus , thyroid dysfunction, renal dysfunction, organic mental disorder or psychoactive-substance related disorder, such as excess consumption of alcohol, amphetamine-like substances, or withdrawal from benzodiazepines.
5.Pregnant and Lactating Women.
|
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Significant decrease in signs and symptoms of GAD assessment based on Hamilton Anxiety rating Scale |
Before intervention- 0th
After intervention- 28th
Follow Up- 43rd day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Generation of in depth analysed data on different aspect of Disease .
Generation of Data on possible unexpected drug reaction |
Before intervention- 0th
After intervention- 28th
Follow Up- 43rd day. |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
25/07/2024 |
| 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="4"
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
|
Anxiety disorders are the most prevalent mental health issues across the world. Generalized anxiety disorder (GAD) is one among the most common kind of anxiety disorders characterized by persistant, excessive, and difficult to control worry and other associated symptoms such as fatigue, difficulty in concentration, sleep disturbances, restlessness, and abdominal discomfort. According to W.H.O Covid 19 pandemic triggered 25% increase in prevalence of anxiety and depression worldwide . Prevalence of Anxiety was found to be 35%, stress 53% in a study conducted on the population of 113,285 individuals.
According to NHMS Survey the overall prevalence of Anxiety Disorders in the adult population was found to be 2.57% and prevalence of GAD was found to be 0.57%. Generalised anxiety disorder is twice as common in women than men and often associated with chronic environmental stress. Usually patient seeks medical help because of the somatic complaints associated with GAD like muscle ache and tension, headaches, backaches, gastrointestinal issues, problems with sleep and fatique. All these leads to increased disability and decreases the quality of life of a person .Individuals with GAD are at significantly increased risk of impaired social and role functioning, mental health, and overall physical-mental well-being. Clinical trials have shown that anxiolytic drugs alone have limited long-term efficacy. Moreover , they often have adverse side effects including dependency, drowsiness, impaired cognition and memory, and sexual dysfunction. Considering wide magnitude of GAD in Indian subcontinent and absence of promising therapy suffering population is turning towards other systems for effective therapies. Being an alarming disease, it requires effective management.
In Ayurveda an exact co-relation to Generalised Anxiety Disorder is not found, but Udvega means anxiety, fear, distress or agitation and Chittodvega can be taken as affliction of mind with these,therefore in this study the term Chittodvega is compared with Generalised Anxiety Disorder. Acharyas have mentioned different Medhya Rasayanas for the management of mental illnesses and also Satwavajaya Chikitsa is a unique non-pharmacological approach for treating the mental disorders. Satwavajaya Chikitsa mentioned among Trividha Chikitsa by Acharya Charaka not only prevents the impairments of Dhee, Dhriti and Smriti but also brings them back to the normal state, playing a significant role in the maintenance of harmonious state between these three factors ultimately leading to happy healthy state of individual.
Considering that Brahmyadi Churna along with Satvavjaya Chikitsa are taken as trial intervention for the present study.
Whereas Ashvagandha Churna is a proven anxiolytic drug hence along with Satwavajaya Chikitsa it is taken as a control intervention for the present study.
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