| CTRI Number |
CTRI/2024/09/073245 [Registered on: 02/09/2024] Trial Registered Prospectively |
| Last Modified On: |
31/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Effect of the herb Bhangjeera on anxiety. |
|
Scientific Title of Study
|
Evaluation of Extra pharmacopeial herb Bhangjeera (Perilla frutescens Linn.) seed in the management of Generalized Anxiety Disorder (GAD) in adults: An Exploratory Clinical Study |
| 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 Vanshika Sharma |
| Designation |
PG Scholar |
| Affiliation |
All India Institue of Ayurveda, New Delhi |
| Address |
Department of Dravyaguna Vigyana All India Institute of Ayurveda (AIIA) Mathura Road Gautam Puri Sarita Vihar New Delhi
South
DELHI
110076
India |
| Phone |
7018051065 |
| Fax |
|
| Email |
svanshika60@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Meena Deogade |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Ayurveda (AIIA) New Delhi |
| Address |
Department of Dravyaguna Vigyana All India Institute of Ayurveda (AIIA) Mathura Road Gautam Puri Sarita Vihar New Delhi
South
DELHI
110076
India |
| Phone |
9404049302 |
| Fax |
|
| Email |
drmmeena@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vanshika Sharma |
| Designation |
PG Scholar |
| Affiliation |
All India Institue of Ayurveda, New Delhi |
| Address |
Department of Dravyaguna Vigyana All India Institute of Ayurveda (AIIA) Mathura Road Gautam Puri Sarita Vihar New Delhi
South
DELHI
110076
India |
| Phone |
7018051065 |
| Fax |
|
| Email |
svanshika60@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Ayurveda, Mathura Road Gautam Puri Sarita Vihar New Delhi (110076) |
|
|
Primary Sponsor
|
| Name |
Dr Vanshika Sharma |
| Address |
All India Institute of Ayurveda, Mathura Road Gautam Puri Sarita Vihar New Delhi (110076) |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Vanshika Sharma |
All India Institute of Ayurveda, New Delhi |
Screening OPD number 4-5,Department of Dravyaguna Vigyana ,Room number 16, Ground Floor Hospital Block
South
DELHI |
7018051065
svanshika60@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Division of Translational Research & Biostatistics |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F40-F48||Anxiety, dissociative, stress-related, somatoform and other nonpsychotic mental disorders. 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: Perilla frutescens Linn (Bhangjeera), Reference: NA, Route: Oral, Dosage Form: Modaka, Dose: 12(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Lukewarm Water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients fulfilling the diagnostic criteria of GAD as per DSM V (Diagnostic and
Statistical Manual of Mental Disorders, 5th edition) guidelines.
2. Hamilton anxiety score 17 - 24. xviii
3. Age 18 to 45 years, irrespective to gender, caste, socio-economic status. |
|
| ExclusionCriteria |
| Details |
1. Patient suffering from known case of psychiatric disorder other than GAD.
2. Patient with known history of Thyroid dysfunction or any major systemic diseases requiring significant care.
3. Patient suffering from GAD and taking other medications.
4. Patient with substance, alcohol, Smoker’s dependence.
5. Pregnant women and lactating mothers.
6. Patients who are a known case of Diabetes Mellitus. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the anxiolytic effect of extrapharmacopoeial herb : Bhangjeera (Perilla frutesecens Linn) |
At the end of the intervention period i.e 60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Development of laddu/modaka of Bhangjeera (Perilla frutescens) |
Baseline |
|
|
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 3 |
|
Date of First Enrollment (India)
|
01/01/2025 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 (ADs) are among the most common psychiatric illnesses that impact
the quality of life, functioning and productivity of an individual. As per the World Mental
Health Survey (WMHS), the lifetime prevalence of Anxiety disorders across different
countries ranges between 3% and 19%. According to NMHS 2016, prevalence of ADs
was 2.57%.Though, the prevalence of anxiety disorder is less but the overall quality of
life of these patients is poor.
The conventional treatment of this condition indicates the use of sedatives, hypnotics and
antidepressant drugs along with the cognitive behavioral therapy. Still, the prognosis for
patients with generalized anxiety disorder is guarded. Many patients are not compliant with medications because of cost and adverse effects. Relapses are common, and patients
often search for physicians who comply with their needs. Because of the lack of conventional
medicine to cure the disorder and their considerable side effects, many opt for alternative
therapies.The herb Bhangjeera (Perilla frutescens Linn) has traditionally been used to treat depression-related disease, and is reported as potent anxiolytic. Japan has reported its clinical potential
in Age related Cognitive Decline (ARCD). Reviews reflect that oral administration of seed
is not reported in any clinical studies. Due to unfavorable palatability of seeds in their original
form, it is difficult to administer the seeds for therapeutic purposes for longer duration. To
explore its utilization, efforts are needed for development of better consumable forms / food
products, so that they can be incorporated in the diets of common man. Further the developed
consumable forms can also be used to ensure better patient compliance and evaluation of herb
for its pharmacological potential. |