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CTRI Number  CTRI/2019/11/022100 [Registered on: 21/11/2019] Trial Registered Prospectively
Last Modified On: 18/11/2019
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   Study the effect of herbal medicine, Sensoril (Aswagandha)in patients with chronic stress 
Scientific Title of Study   An 8 week, randomized, double blind, placebo controlled study of the efficacy, safety and tolerability of Sensoril in subjects with mild to moderate, chronic stress 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR TUHIN KANTI BISWAS 
Designation  PROFESSOR 
Affiliation  J B Roy State Ayurvedic Medical College and Hospital 
Address  Research Unit J B ROY STATE AYURVEDIC MEDICAL COLLEGE AND HOSPITAL 170 172 RAJA DINENDRA STREET, KOLKATA
Research Unit J B ROY STATE AYURVEDIC MEDICAL COLLEGE AND HOSPITAL 170 172 RAJA DINENDRA STREET, KOLKATA
Kolkata
WEST BENGAL
700004
India 
Phone  9433173272  
Fax    
Email  biswastuhin@rediffmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR TUHIN KANTI BISWAS 
Designation  PROFESSOR 
Affiliation  J B Roy State Ayurvedic Medical College and Hospital 
Address  Research Unit J B ROY STATE AYURVEDIC MEDICAL COLLEGE AND HOSPITAL 170 172 RAJA DINENDRA STREET, KOLKATA
Research Unit J B ROY STATE AYURVEDIC MEDICAL COLLEGE AND HOSPITAL 170 172 RAJA DINENDRA STREET, KOLKATA
Kolkata
WEST BENGAL
700004
India 
Phone  9433173272  
Fax    
Email  biswastuhin@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  DR TUHIN KANTI BISWAS 
Designation  PROFESSOR 
Affiliation  J B Roy State Ayurvedic Medical College and Hospital 
Address  Research Unit J B ROY STATE AYURVEDIC MEDICAL COLLEGE AND HOSPITAL 170 172 RAJA DINENDRA STREET, KOLKATA
Research Unit J B ROY STATE AYURVEDIC MEDICAL COLLEGE AND HOSPITAL 170 172 RAJA DINENDRA STREET, KOLKATA
Kolkata
WEST BENGAL
700004
India 
Phone  9433173272  
Fax    
Email  biswastuhin@rediffmail.com  
 
Source of Monetary or Material Support  
Natreon INC, Rishi Tech Park, Premises No. 02 360, New Town, Kolkata 700160 
 
Primary Sponsor  
Name  Natreon Inc Branch Office India 
Address  Research and Development Center Premise No 02 360 Rishi Tech Park (Ground Floor) Action Area 1D Newtown Kolkata 700 156  
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 
Srikanta Pandit  Research Unit, J.B. Roy State Ayurvedic Medical College and Hospital  170 172 Raja Dinendra Street Kolkata
Kolkata
WEST BENGAL 		 9831723650

srikantapandit@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee JB Roy State Ayurvedic Medical College and Hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F411||Generalized anxiety disorder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo  500 mg single daily for 8 weeks 
Intervention  Aqueous extract of Withania sominifera   Aqueous extract of Withania somnifera coded as Sensoril will be administered in three divided doses as 125 mg single daily for 8 weeks, 250 mg single daily for 8 weeks and 500 mg single daily for 8 weeks  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Age 18 to 60 years, Community dwelling subjects, predominant complaint is anxiety, depression, or sleep disturbances related to chronic stress having Score of 3 or higher on Item 3 of the PSS and Score of 28 or higher on the PSS. This cut off implies an average score of at least 2 for each item. Anxiety, depression, or other symptoms are not a result of exposure to recent, current major life events to which adaptation may occur as a natural event like bereavement or to which adaptation is unlikely cancer or other severe or terminal medical illness. Duration of anxiety, depression, insomnia, or other symptoms related to stress is more than 3 month, this will help to ensure that patients with self limiting stressors are not included, and will help to ensure that patients have failed to cope within 3 months, implying that they will not spontaneously cope, thereafter. Residence within the catchment area of the hospital with reasonable confirmation of feasibility of compliance with study visits. Provision of signed informed consent.
 
 
ExclusionCriteria 
Details  Anticipation of any change in stressors or life events either increase or decrease, across the course of the study. Any clinically significant medical or psychiatric symptoms for which initiation of medication is indicated, subjects with a DSM 5 diagnosis of Generalized Anxiety Disorder and those with a DSM 5 diagnosis of Dysthymia, however, will be eligible for recruitment provided that their Hamilton Anxiety or HAM-A and Hamilton Depression or HAM-D rating scale scores are each below 18. Any personality disorder, any alcohol or substance use disorder, current smoking 10 or more cigarettes per day will be excluded. Suicidal intent at any time during the past 4 weeks, as determined by self report will be excluded. Use of any psychotropic or nutraceuticals medication for more than 1 week during the past month, use of any psychotropic or nutraceuticals drug during the past week, current treatment with psychotherapy will be excluded.Past history of non-response to Withania somnifera will be excluded. Presence of untreated or unstable major medical comorbidity such as diabetes, hypertension, ischemic heart disease and neuropsychiatric disease, in this context, unstable refers to the occurrence of either a medical incident related to the disease or medication dose adjustment related to the disease during the past month will be excluded. Current or past history of any major medical or neuropsychiatric disorder that may confound the clinical picture of stress and the rating of its severity like mood disorder, psychosis, head injury and stroke will be excluded. If female and of childbearing potential, recruitment will be considered only if the patient is not pregnant, as determined by a pregnancy test, and not lactating, and if an undertaking is provided in the informed consent form that the patient will take sufficient contraceptive or other precautions to avoid conception during the treatment period and for at least one month thereafter, will be excluded.
 
 
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 
The efficacy of Sensoril prepared from aqueous extract of Withania somnifera will be determined in relation to placebo as a control treatment, across an 8 week period of treatment in community dwelling subjects who seek assistance for mood, sleep, and other psychological and behavioral problems related to stress, anxiety, and depression by questionnaire and biochemical tests.
 		 From base line to 8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To determine whether Sensoril attenuates anxiety or depression or reduces sleep latency and improves sleep efficiency. To determine whether Sensoril attenuates biochemical indices of inflammation and stress like salivary alpha amylase, serum cortisol, ACTH, DHEAS, hs C reactive protein, IL1b, IL6, and TNFa. To determine whether Sensoril is associated with discontinuation symptoms one week after abrupt drug discontinuation.
 		 30 months 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   02/12/2019 
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="6"
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)?  

Brief Summary  

This study is a randomized, double blind, placebo-control group, single centre trial for efficacy, safety and tolerability of Sensoril 125, 250 and 500 mg daily for 2 months in 120 patients mild to moderate stress that will be conducted in India. Subjects will follow up at 2 weeks, 4 weeks, and at an 8 week treatment endpoint. There will be an additional follow up at 9 weeks to assess treatment discontinuation symptoms, if any, and to assign the patient to treatment as usual. Clinical efficacy will be assessed using the following instruments. Perceived Stress Scale, HAM A, The 17 item HAM D, PSQI, WHOQoL Bref and VAS for energy, vitality, and drive. Biochemical efficacy will be assessed through the following investigations: Salivary alpha amylase, plasma cortisol, ACTH, DHEAS, hs C reactive protein, IL1b, IL6 and TNFa. Clinical safety will be assessed through  assessments criteria like pulse and heart rate, systolic and diastolic blood pressure and general and systemic physical examination. Clinical tolerability will be assessed using SAFTEE. Data will be statistically analyzed by examining the improvement score at treatment endpoint in a multivariable linear regression analysis with group and baseline score as the independent variables. Alpha for statistical significance will be set at p less than 0.05.

 
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