FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/02/049470 [Registered on: 06/02/2023] Trial Registered Prospectively
Last Modified On: 31/03/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Crossover Trial 
Public Title of Study   Clinical trial on sleep disorders  
Scientific Title of Study   A double blind, randomized, crossover, two period, parallel group, single center, placebo controlled study to evaluate safety and efficacy of WSCS IIIM (comprising extract A and Extract B) for sleep disorder(s) in otherwise healthy volunteers 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
RRS/ AC /Insomnia/2022 Version 1.0 26 October 2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ashok Godavarthi 
Designation  C E O 
Affiliation  Radiant research services pvt. Ltd 
Address  Plot No:99/A, 8th Main Road, III Phase, Peenya Industrial Area, Bengaluru Karnataka, India

Bangalore
KARNATAKA
560058
India 
Phone  9880999297  
Fax    
Email  surya.ashok@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ashok Godavarthi 
Designation  C E O 
Affiliation  Radiant research services pvt. Ltd 
Address  Plot No:99/A, 8th Main Road, III Phase, Peenya Industrial Area, Bengaluru Karnataka, India


KARNATAKA
560058
India 
Phone  9880999297  
Fax    
Email  surya.ashok@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ashok Godavarthi 
Designation  C E O 
Affiliation  Radiant research services pvt. Ltd 
Address  Plot No:99/A, 8th Main Road, III Phase, Peenya Industrial Area, Bengaluru Karnataka, India


KARNATAKA
560058
India 
Phone  9880999297  
Fax    
Email  surya.ashok@gmail.com  
 
Source of Monetary or Material Support  
Indian Institute Of Intergrative Medicine, Post Bag No. 3, Canal Road, Jammu-180001, India 
 
Primary Sponsor
Modification(s)  
Name  CSIR Indian Institute of Integrative Medicine  
Address  Post Bag No. 3, Canal Road, Jammu-180001, India 
Type of Sponsor  Research institution 
 
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 
DrReginald Varadarajulu  Medstar Speciality Hospital  641/17, Department of neurology Room no 3 1/3, Kodigehalli Main Rd, Sahakar Nagar, Sanjeevini Nagar, Bengaluru, Karnataka 560092
Bangalore
KARNATAKA 		 9880101778

varadarajuludr.medstar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Medstar Speciality Hospital Ethics committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G470||Insomnia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo 300 mg capsules  Dosage: Capsules Dose: 300 mg Frequency: 2capsules at night after 1 hour of dinner Duration: 14 days (Day 1 to day 7 Wash period 7 days again Day 1 to Day 7) 
Intervention  WSCS IIIM 300 mg capsules   Dosage: Capsules Dose: 300 mg Frequency: 2capsules at night after 1 hour of dinner Duration: 14 days (Day 1 to day 7 Wash period 7 days again Day 1 to Day 7)  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  72.00 Year(s)
Gender  Both 
Details  1. Male volunteers who are 18 or older to 72 years.
2. Insomnia Severity Index 10-14
3. Meet diagnostic criteria for Insomnia Disorder per DSM-5
4. Willing and able to sign Informed consent form
5. Not planning on moving away from the area for the subsequent 12 weeks
6.Subjects should not have Milk during the study 
 
ExclusionCriteria 
Details  1. Night shift workers and individuals who nap 3 or more times per week over the preceding month
2. Consumption of caffeine beverages tea, coffee, or cola comprising usually more than 5 cups or glasses per day
3. Participation in another trial for insomnia
4. Subjects having milk on regular basis.
5. Persons who are unable to participate for the entire duration of the study, or in the opinion of the investigators, are likely to be noncompliant with the obligations inherent in the trial participation
6. Persons self describing with severe anxiety or severe depression BDI score of 29 or higher or severe anxiety BAI score of 36 or higher
7. Persons with a history of epilepsy, seizures, or dementia any significant,
severe or unstable, acute progressive medical or surgical condition stroke or head injury
8. Current alcohol or substance abuse/dependence must have greater than90 days of sobriety
9. Presence of other neurological disorders Ex multiple sclerosis, Parkinsons Disease
10. Presence of an untreated or unstable medical or psychiatric comorbid condition ex major depressive disorder or psychotic disorder requiring admission within the last two years People using psychotropic medication hypnotic or sedative medications may be included if they are on a stable dosage for the last 2 months prior to the study, if the dose remains stable throughout the study, and if the medication is judged to not interfere with the study outcomes.
11. Currently on medications known to produce insomnia ex
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
1. The primary end point is completion of 1-week treatment sessions on Day 0 and Day 8 with
cross over assessment.
2. Improvement of insomnia outcome is measured by Insomnia Severity Index (ISI), selfreported
questionnaire, actigraphy, polysmonography on Day 0 & Day 8. 		 Day 0 & Day 8. 
 
Secondary Outcome  
Outcome  TimePoints 
The Secondary end point is improvement in biomarker values from Day 0 to Day 8  Day 0 & Day 8. 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   10/02/2023 
Date of Study Completion (India) 16/03/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
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 - NO
Brief Summary  
The objective of this study is to validate the safety & efficacy of oral administration of Ashwagandha capsule (comprising extract A and Extract B) for sleep disorder (Insomnia) in otherwise healthy volunteersInsomnia, also known as sleeplessness, is a sleep disorder in which people have trouble sleeping. They may have difficulty falling asleep, or staying asleep as long as desired. Insomnia is typically followed by daytime sleepiness, low energy, irritability, and a depressed mood. It may result in an increased risk of motor vehicle collisions, as well as problems focusing and learning.

Withania somnifera, known commonly as Ashwagandha or winter cherry, is an evergreen shrub in the Solanaceae or nightshade family that grows in India, the Middle East, and parts of Africa.
Several other species in the genus Withania are morphologically similar. It has been traditionally known since ancient times in India for its numerous beneficial health activities. WS is one of the most important herbs in Ayurveda, which has been used for >3000 years in stress management, energy elevation and improving cognitive health and to lower inflammation, blood sugar levels, cortisol, anxiety, and depression. The plant is an erect, grayish, evergreen shrub with long tuberous roots, short stems, ovate and petiolate leaves, and greenish axillary and bisexual flowers. The leaves, roots, stems and flowers bear medicinal values with 29 common metabolites derived from the leaves
and root extracts. To date, this medicinal plant has been found to have anti-epileptic, antiinflammatory, anti-arthritic, anti-depressant, anti-coagulant, anti-oxidant, anti-diabetic, anti-pyretic efficacies along with palliative effects such as analgesic, rejuvenating, regenerating and growthpromoting effects.
 
Close