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CTRI Number  CTRI/2022/04/042133 [Registered on: 25/04/2022] Trial Registered Prospectively
Last Modified On: 22/01/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Efficacy of Ashwagandha extract on generalized anxiety disorder 
Scientific Title of Study   A randomized double-blind placebo-controlled study to determine the efficacy of ashwagandha extract on generalized anxiety disorder 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
AN-11SHO0322H3-WES08 version 1 dated March 15,2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Binu T Kuruvilla 
Designation  DGM, Research and Development 
Affiliation  Arjuna Natural Private Ltd 
Address  Arjuna Natural Pvt Ltd Bank Road, Aluva Ernakulam

Ernakulam
KERALA
683101
India 
Phone  09447818432  
Fax    
Email  drbinu@arjunanatural.com  
 
Details of Contact Person
Scientific Query  
Name  Sooraj R Kartha 
Designation  Clinical Research Associate 
Affiliation  Arjuna Natural Private Ltd 
Address  Arjuna Natural Pvt Ltd Bank Road, Aluva Ernakulam

Ernakulam
KERALA
683101
India 
Phone  9288004381  
Fax    
Email  sooraj@arjunanatural.com  
 
Details of Contact Person
Public Query  
Name  Sooraj R Kartha 
Designation  Clinical Research Associate 
Affiliation  Arjuna Natural Private Ltd 
Address  Arjuna Natural Pvt Ltd Bank Road, Aluva Ernakulam

Ernakulam
KERALA
683101
India 
Phone  9288004381  
Fax    
Email  sooraj@arjunanatural.com  
 
Source of Monetary or Material Support  
Arjuna Natural Pvt Ltd, Bank Road, Aluva 
 
Primary Sponsor  
Name  Arjuna Natural Private Limited 
Address  Arjuna Natural Pvt Ltd, Bank Road, Aluva 
Type of Sponsor  Other [Nutraceutical company] 
 
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 Deo Nidhi Mishra  Nirmal Hospital  Department of Internal Medicine, Opp. MLB Medical College, Gate No:3, Kanpur Road, Jhansi-284128
Jhansi
UTTAR PRADESH 		 09415031689

drmishra.nirmal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Nirmal Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Generalized Anxiety Disorder 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ashwagandha extract (SHPR)  Ashwagandha extract 120mg , one capsule daily for 60 days 
Intervention  Ashwagandha extract (SHPR)  Ashwagandha extract 60mg, one capsule daily for 60 days 
Comparator Agent  Placebo  microcrystalline cellulose 120mg , one capsule daily for 60 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Fulfilling the DSM –IV Criteria for Generalized Anxiety Disorder.
2. HAM-A total score > 20, Item 1 (anxious mood) ≥ 2, Item 2 (tension) ≥ 2.
3. Cortisol > 25 mcg/dl (morning (8– 9 am).
4. Clinical Global Impression-Severity of Illness (CGI-S) score ≥ 4.
5. Healthy subjects willing to give their informed consent. 
 
ExclusionCriteria 
Details  1. Montgomery-Asberg Depression Rating Scale (MADRS) total score greater than 12, with MADRS items 1 and 2 "apparent sadness" and "reported sadness” greater than or equal to 2.
2. Current serious suicidal or homicidal risk, MADRS Item 10 (suicidal thoughts) score greater than 1 at the screening or randomization visit or a suicide attempt in the 6 months prior to screening.
3. Night shift workers (8 pm to 8 am)
4. Subjects who have not participated in a similar investigation in the past three months.
5. Having psychotic tendencies such as schizophrenia or taking any psychotropic medicines.
6. Alcohol dependence, chain-smoking, any psychedelic, narcotic substance abuse.
7. psychotic tendencies such as schizophrenia or taking any psychotropic medicines.
8. co-morbid illnesses such as cardiovascular, endocrine, renal, or other chronic diseases likely to affect stress/anxiety or limit normal function.
9. Positive pregnancy, breastfeeding, pregnancy planning.
10. Any serious acute or chronic medical condition that in the judgment of the investigator would make it inappropriate for the subject to participate in this study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Change From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A)   Day 0 to Day 60 
 
Secondary Outcome  
Outcome  TimePoints 
Change from Baseline in the HAM-A Score  From baseline to day 15, 30, & 45  
Change from Baseline in the Cortisol level  From baseline to days 0,15,30,45,60 
Change from Baseline in Clinical Global Impression scores   From baseline to days 0,30,60  
Change from Baseline in PSS   From Baseline to days 0, 30, 60 
Change from Baseline in PGIC   From Baseline to days 0, 30,60 
Change from Baseline in CBC, RFT, LFT   From Baseline to days 0,30,60 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   25/04/2022 
Date of Study Completion (India) 15/08/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drbinu@arjunatural.com].

  6. For how long will this data be available start date provided 01-04-2023 and end date provided 13-04-2026?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Generalized anxiety disorder (GAD) is marked by excessive and exaggerated worry about everyday life without an inducing event. The anxiety can dominate a person’s thinking so much so that it affects his work and relationships, even his day-to-day activities. This double-blinded placebo-controlled study intends to study the efficacy of ashwagandha extract 60 and 120mg in the management of GAD. The primary outcome is the change in the HAMA from baseline to day 60. The study duration is 60 days.  
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