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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 
Public Title of Study   Role of Ashwagandha in the management of Mild to Moderate Depression among adolescents 
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   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
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  
 
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  
 
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  
 
Source of Monetary or Material Support  
All India Institute of Ayurveda 
 
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 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
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 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee All India Institute of Ayurveda   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:F330||Major depressive disorder, recurrent, mild. Ayurveda Condition: VISHADAH/DINATA (KEVALAVATA), (2) ICD-10 Condition:F331||Major depressive disorder, recurrent, moderate. Ayurveda Condition: VISHADAH/DINATA (KEVALAVATA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-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
2Comparator Arm (Non Ayurveda)-Placebo and CounselingPlacebo 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)
 
Inclusion Criteria  
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 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduction in the PHQ-9 score.  Before Treatment-After Treatment (8weeks) 
 
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) 
 
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" 
Phase of Trial   N/A 
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 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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 negligencePromoting 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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