| CTRI Number |
CTRI/2021/11/037967 [Registered on: 11/11/2021] Trial Registered Prospectively |
| Last Modified On: |
10/11/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda Behavioral |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
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Public Title of Study
|
Role of Ashwagandha in the management of Mild to Moderate Depression among adolescents |
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Scientific Title of Study
|
Effectiveness of Ashwagandha (Withania somnifera (L.) Dunal) In The Management Of Vishaada (Mild To Moderate Depressive Disorder) Among Adolescents: A Randomized Double Blind Placebo Controlled Trial |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR SONAM |
| Designation |
PhD Scholar |
| Affiliation |
All India Institute of Ayurveda (AIIA) |
| Address |
OPD-208, Dept. of Kaumarabhritya, Hospital block, All India Institute of Ayurveda, Sarita Vihar, Mathura Road, New Delhi
South DELHI 110076 India |
| Phone |
8285842084 |
| Fax |
|
| Email |
sonam2209best@gmail.com |
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Details of Contact Person Scientific Query
|
| Name |
DR Mahapatra Arun Kumar |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Ayurveda (AIIA) |
| Address |
OPD-208, Dept. of Kaumarabhritya, Hospital block, All India Institute of Ayurveda, Sarita Vihar, Mathura Road, New Delhi
South DELHI 110076 India |
| Phone |
8506821947 |
| Fax |
|
| Email |
ayuarun@gmail.com |
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Details of Contact Person Public Query
|
| Name |
DR SONAM |
| Designation |
PhD Scholar |
| Affiliation |
All India Institute of Ayurveda (AIIA) |
| Address |
OPD-208, Dept. of Kaumarabhritya, Hospital block, All India Institute of Ayurveda, Sarita Vihar, Mathura Road, New Delhi
South DELHI 110076 India |
| Phone |
8285842084 |
| Fax |
|
| Email |
sonam2209best@gmail.com |
|
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Source of Monetary or Material Support
|
| All India Institute of Ayurveda |
|
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Primary Sponsor
|
| Name |
All India Institute of Ayurveda |
| Address |
All India Institute of Ayurveda, Gautam Puri Sarita Vihar Mathura Road, New Delhi |
| Type of Sponsor |
Research institution and hospital |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sonam |
All India Institute of Ayurveda |
OPD-208 All India Institute of Ayurveda Hospital Block, Gautam Puri Sarita Vihar Mathura Road New Delhi South DELHI |
8285842084
sonam2209best@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee All India Institute of Ayurveda |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F330||Major depressive disorder, recurrent, mild. Ayurveda Condition: VISHADAH/DINATAÂ (KEVALAVATA), (2) ICD-10 Condition:F331||Major depressive disorder, recurrent, moderate. Ayurveda Condition: VISHADAH/DINATAÂ (KEVALAVATA), |
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Intervention / Comparator Agent
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| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Ashwagandha Aqueous extract and Counseling | (Procedure Reference: NA, Procedure details: Counseling will be done as per the SOP and guidelines for Adolescent Depression (GLAD),
Duration: 30-60min,
Frequency: one session once in a week for 8 weeks,
Timings: Afternoon or morning (as per feasibility of the patient)) (1) Medicine Name: Ashwagandha Aqueous extract, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 125(mg), Frequency: bd, Duration: 8 Weeks | | 2 | Comparator Arm (Non Ayurveda) | | - | Placebo and Counseling | Placebo capsules containing wheat/starch powder with identical shape, size, doses (125mg BD) and duration (8weeks) will be provided to the patient.
counseling will be done as per standard guidelines and SOP, for same duration as of interventional group (once in a week for 8 wks) |
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Inclusion Criteria
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| Age From |
10.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Participants showing signs of Mild to Moderate Depression as per DSM-V Criteria. (PHQ-9 score 5-14).
Participants providing written informed consent of caretakers/parents.
Participants providing written informed assent to participate in the study. |
|
| ExclusionCriteria |
| Details |
No Depression (PHQ- 9 score below or equals to 4) along with no other clinical manifestation.
Severe Depression (PHQ- 9 score equal or above 15).
Intelligent Quotient (IQ) Below 70 [Borderline Intelligence].
Any severe co-morbid psychiatric disorder, especially a diagnosis of bipolar disorder, schizophrenia, autism spectrum disorder, schizoaffective disorder or organic psychiatric disorder assessed by taking detailed history and examination.
Any other medical or neurological conditions or any other illness interfering with interventions.
Participants suffering from any systemic illness, history of epilepsy or chronic illness like hypo or hyperthyroidism.
Substance use disorder or dependency, suicidal ideations.
Current use of Anti-epileptics, anti-psychotic or psychotropic drugs (e.g., Selective Serotonin Reuptake Inhibitor, Serotonin and norepinephrine reuptake inhibitors etc.) and any other investigational drugs |
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant and Investigator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in the PHQ-9 score. |
Before Treatment-After Treatment (8weeks) |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in sleep quality of adolescents.
Improvement in Clinical Global Impression Score.
Improvement in the quality of life (QOL) |
Before Treatment-After Treatment (8weeks) |
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Target Sample Size
|
Total Sample Size="114" Sample Size from India="114"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
N/A |
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Date of First Enrollment (India)
|
20/11/2021 |
| 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 |
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Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
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NIL |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
Mental health is a part of overall health and well-being. It includes all the aspects viz. emotional, psychological as well as social well-being. Mental health is important at every stage of life, from childhood and adolescence through adulthood. The mental health services are the most neglected area among existing health care services. Inaccurate-assessment, lack of trained health-care providers and resources, lack of awareness, paucity of mental health specialists, low-socio-economic conditions and a social stigma of being managed for a mental health condition are the factors associated with its negligence. Promoting and protecting adolescents’ mental health will lead to great public health, economic and demographic benefits along with triple dividend health benefits – for adolescents now, for adolescents’ future lives and for the next generation too. Promotion of good sleeping and dietary habits, early detection and management of common problems (mental as well as social and sexual) may provide long term healthy lifestyle and morbidity and premature mortality may be reduced in adulthood. Considering the spectrum of the problem, the present study has been undertaken with a solution of improving adolescents’ mental health conditions as well as their quality of life. HYPOTHESIS: Clinical symptoms of Depression are reduced with improvement in sleep and quality of life in adolescents aged 10-16 years, diagnosed with mild to moderate depressive disorder who receive oral administration of aqueous extract of Ashwagandha (Withania somnifera (L.) Dunal) root 250mg per day in two divided doses (1 Capsule of 125mg twice daily) with lukewarm water along with counselling therapy for duration of 8 weeks compared with those who receive placebo with counselling therapy with identical doses and periods.
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