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CTRI Number  CTRI/2023/01/049214 [Registered on: 25/01/2023] Trial Registered Prospectively
Last Modified On: 11/07/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A randomized, double-blind standard controlled trial Comparing two leading brands of Ashwagandha products in patients suffering from mental health-related symptoms like stress, anxiety, depression, and sleep disorders. 
Scientific Title of Study   Comparison of two leading brands of Ashwagandha products in patients suffering from mental health related symptoms like stress, anxiety, depression and sleep disorders: A randomized, double-blind, standard 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 Sagar S Mandlik 
Designation  Consultant Physician and Critical Care Specialist 
Affiliation  Vakratund Hospital Pvt. Ltd 
Address  Vakratund Hospital Pvt. Ltd, Raghukul Sankul Behind Hotel Bandhuraj Mumbai Agra National Highway Pathardi Phata Nashik

Nashik
MAHARASHTRA
422010
India 
Phone  9225343885  
Fax    
Email  sagarmandlik007@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Mr Ayan Neogi 
Designation  Managing Director 
Affiliation  Vivforever Aesthetics Pvt. Ltd 
Address  103 A Bhairavi Doordarshan CHS Gokuldham Goregaon East Mumbai

Mumbai
MAHARASHTRA
400063
India 
Phone  9967968612  
Fax    
Email  ayanneogi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Mr Ayan Neogi 
Designation  Managing Director 
Affiliation  Vivforever Aesthetics Pvt. Ltd 
Address  103 A Bhairavi Doordarshan CHS Gokuldham Goregaon East Mumbai

Mumbai
MAHARASHTRA
400063
India 
Phone  9967968612  
Fax    
Email  ayanneogi@gmail.com  
 
Source of Monetary or Material Support  
Herbochem 
Vakratund Hospital 
 
Primary Sponsor  
Name  Herbochem 
Address  38 Technocrats Industrial Estate, Balanagar, Hyderabad 500037 
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 
Dr Sagar S Mandlik  Vakratunda Hospital Pvt. Ltd  Raghukul Sankul, Behind Hotel Bandhuraj, Mumbai Agra National Highway, Pathardi Phata, Nashik
Nashik
MAHARASHTRA 		 9225343885

sagarmandlik007@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Navsanjeevani Hospital Ethics Committee  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, (2) ICD-10 Condition: F439||Reaction to severe stress, unspecified, (3) ICD-10 Condition: F330||Major depressive disorder, recurrent, mild,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ashwagandha Capsules of Herbochem   Ashwagandha Capsules of Herbochem 500 mg, Once Daily, Orally for 90 Days. 
Comparator Agent  KSM 66 Ashwagandha 600 mg Capsules  KSM 66 Ashwagandha 600 mg Capsules, Once Daily, Orally for 90 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients of either sex between 18 and 60 years of age
2. Patients suffering from mental health-related symptoms of with stress, anxiety, depression, and sleep disturbance.
3. Patients providing written informed consent
 
 
ExclusionCriteria 
Details  1. Pregnant and lactating patients
2. Patients with liver and kidney impairment
3. Patients addicted to alcohol or psychotropic drugs
4. Patients with severe other psychiatric illnesses
5. Patients who have participated in any clinical trial in the last six months
6. Patients taking Ayurvedic medicines containing Ashwagandha.
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
• Reduction in Hamilton Depression Scale Score on day 30, 60 and 90, from baseline score on day 0
• Reduction in Beck Anxiety Inventory score on day 30, 60 and 90, from baseline score on day 0
• Reduction in Perceived Stress Score on day 30, 60 and 90 from baseline score on day 0
• Improvement in Pittsburgh Sleep Quality Index on day 30, 60 and 90 from baseline score on day 0 		 Day 0, 30, 60 & 90 
 
Secondary Outcome  
Outcome  TimePoints 
• Reduction in Serum Cortisol level on day 30, 60 and 90 from baseline level on day 0  Day 0, Day 30, Day 60 & Day 90 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   31/01/2023 
Date of Study Completion (India) 19/08/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 https://www.msjonline.org/index.php/ijrms/article/view/13146 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Mental health related symptoms are common among the population. These typically include depression that interferes with the patient enjoying a healthy and happy life. In a very large number of cases, it is associated with stress and anxiety, so that most patients suffer from these symptoms concomitantly. A commonly associated problem is that of sleep disorders, that worsen the condition of the patient. In the recent past, prolonged lockdown, social isolation and economic problems have added to the problem of depression leading to major illnesses.

Current treatment of these mixed mental problems leaves much to be desired, and most drugs have serious adverse effects such as insomnia/sleepiness, sexual dysfunction, tolerance and weight gain. The biggest problem with some of these drugs is delayed onset of action in addition to low efficacy. Ashwagandha (Withania somnifera) has demonstrated a variety of beneficial effects in animal and human studies including adaptogenic, anti-stress, anti-anxiety an anti-depressant activity. It has also been used for long to treat sleep disturbance. In this study a formulation of WS is being studied in comparison with a marketed brand on a double blind, randomized, basis, using a variety of scales for anxiety, depression, stress and sleep quality. For each of these symptoms a specific scale that has been validated worldwide will been used. 
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