FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2019/03/018074 [Registered on: 13/03/2019] Trial Registered Prospectively
Last Modified On: 25/06/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A Clinical study of Ashwagandha extract on Sleep in patients with sleep difficulty and Healthy individuals 
Scientific Title of Study   Clinical Evaluation of Ashwagandha Standardized Extract (KSM 66) for its Pharmacological Actions on Sleep in Subjects Having Insomnia and Healthy Subjects: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
DYP-Pharm-WS-02-2018; Version 1.1, dt. 09/04/2018  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Deepak Langade 
Designation  Professor and Head, Pharmacology 
Affiliation  Dr D Y Patil Medical College, Hospital And Research Center 
Address  Department of Pharmacology 5th floor D Y Patil University School of Medicine and Hospital Plot NO. 2, Sector-5, Nerul, Navi Mumbai

Thane
MAHARASHTRA
400706
India 
Phone  02227702218  
Fax  02227709576  
Email  deepak.langade@dypatil.edu  
 
Details of Contact Person
Scientific Query  
Name  Deepak Langade 
Designation  Professor and Head, Pharmacology 
Affiliation  Dr D Y Patil Medical College, Hospital And Research Center 
Address  Department of Pharmacolgy 5th floor D Y Patil University School of Medicine and Hospital Plot NO. 2, Sector-5, Nerul, Navi Mumbai

Thane
MAHARASHTRA
400706
India 
Phone  02227702218  
Fax  02227709576  
Email  deepak.langade@dypatil.edu  
 
Details of Contact Person
Public Query  
Name  Deepak Langade 
Designation  Professor and Head, Pharmacology 
Affiliation  Dr D Y Patil Medical College, Hospital And Research Center 
Address  Department of Pharmacolgy 5th floor D Y Patil University School of Medicine and Hospital Plot NO. 2, Sector-5, Nerul, Navi Mumbai

Thane
MAHARASHTRA
400706
India 
Phone  02227702218  
Fax  02227709576  
Email  deepak.langade@dypatil.edu  
 
Source of Monetary or Material Support  
Dr D Y Patil Medical College, Hospital and Research Center Plot 2, Sector 5, Nerul, Navi Mumbai 400706 
 
Primary Sponsor  
Name  Dr D Y Patil Medical College Hospital and Research Center 
Address  Plot 2 Sector 5 Nerul Navi Mumbai 400706 
Type of Sponsor  Private medical college 
 
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 Deepak Langade  D Y Patil Medical College, Hospital and Research Center  Department of Pharmacology 5th floor D Y Patil UNiversity School of Medicine & Hospital Sector-5, Nerul, Navi Mumbai
Thane
MAHARASHTRA 		 02227702218

deepak.langade@dypatil.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC), Padmashree Dr D Y Patil Medical College, Hospital and Research Center, Navi Mumbai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F510||Insomnia not due to a substance orknown physiological condition,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ashwagandha extract  Capsule KSM 66 300mg One daily capsule for 90 days The Ashwagandha root powder (grinded) contains around 0.5% with anolides (maximum). KSM 66 Ashwagandha root extract contains 5% with anolides. 
Comparator Agent  Placebo capsule  Onecapsule daily for 90 days Placebo capsule identical to KSM 66 Ashwagandha but without active ingredients 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Diagnosis of insomnia based on DSM-IV criteria
2. More than 30 minutes to fall asleep and subjective total sleep time of ≤6.5 hours per night (for at least 3 nights per week); and daytime complaints associated with disturbed sleep
3. Habitual bedtime between 8.30 pm to midnight
4. Body Mass Index between 16.5 to 30 kg/sq.m.
5. Subjects able to understand the sleep diary and are able to and willing to fill the sleep log diary and follow other procedures required by the study protocol
6. Subjects who sign the informed written consent 
 
ExclusionCriteria 
Details  1. Pregnant or breast-feeding women or women with positive urinary pregnancy test at screening.
2. Known clinically significant endocrine, metabolic, hepatic, renal, cardiovascular, gastrointestinal, respiratory, haematological or neurological illnesses.
3. Presence of any current psychiatric disorders that are judged by investigator as potentially causing or contributing to insomnia.
4. Subjects who suffer from sleep disorder other than primary insomnia including restless leg syndrome and sleep apnea.
5. Substance dependence/ abuse in the past one year or with alcohol abuse are ineligible.
6. Those using tobacco products during night awakenings.
7. History of seizures or significant head trauma.
8. Subjects who travelled across four or more time zones or worked on night or rotating shifts in previous 7 days before study initiation or who plan to do the same during the study period.
9. Currently taking any medication on a regular basis (except for antihypertensives, antidiabetics, lipid lowering agents and drugs for primary cardiovascular prophylaxis).
10. Any other investigational drug was used within three months prior the entry in this study.
11. Those who cannot be relied upon to comply with the test procedures or are unwilling to give informed consent. 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Sleep Onset Latency (SOL)  6 wks. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Total sleep time (TST) by Actigraphy
2. Wake After Sleep Onset by Actigraphy
3. Sleep Efficiency, i.e. Total Time In Bed (TTIB)
4. Pittsburgh Sleep Quality Index (PSQI)
5. Change from baseline in number and duration of sleep interruptions (assessed by Sleep log)
6. Quality of sleep (Sleep log)
7. Day-time naps (Sleep log)
8. Nature of waking activities (Sleep log)
9. Mental alertness on rising
10. HAM-A score
11. Adverse events 		 Baseline, 1 week, 3 weeks and 6 weeks 
 
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   N/A 
Date of First Enrollment (India)   08/04/2019 
Date of Study Completion (India) 10/04/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 22/07/2019 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not yet published 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Insomnia is a common public health problem with an estimated prevalence in both Western and Asian general populations in the range of 11-50%. Insomnia refers to unsatisfactory sleep quantity, manifesting as difficulty in falling asleep or early morning awakening, with or without poor sleep quality, manifesting as increased number of nightly awakenings or daytime sleepiness. It is classified as primary insomnia when it is not known to be due to any precipitating factor. An estimated 10-15% adults suffer from chronic primary insomnia. Primary insomnia is a sleep disorder not attributable to a medical, psychiatric, or environmental cause. 
Plant derived drugs have been used since antiquity for the treatment of insomnia. Ashwagandha is commonly used in emaciation of children (when given with milk, it is the best tonic for children), debility from old age, rheumatism, vitiated conditions of vata, leucoderma, constipation, insomnia, nervous breakdown, goiter etc. (Sharma, 1999). This herb is considered an adaptogen which is a nontoxic herb that works on a nonspecific basis to normalize physiological function, working on the HPA axis and the neuroendocrine system. It is effective for insomnia but does not act as a sedative. It’s rejuvenative and nervine properties produce energy which in turn help the body to settle and sleep. Thus, it helps the body to address a stress related condition rather than masking it with sedatives. An herb that rejuvenates the nervous system, erases insomnia and eases stress. Animal and human studies have demonstrated that Ashwagandha has anti-anxiety and mood-elevating capabilities. However, clinical effects of Ashwagandha in sleep are lacking. Hence, this prospective, randomized, placebo-controlled study is being planned to evaluate the pharmacological effects of Ashwagandha Standardized Extract (KSM66) on sleep in subjects having insomnia and healthy subjects.
The aim of this study is to assess the potential of standardized extract Ashwagandha (Withania Somnifera) in treatment of Insomnia.
This work will try to identify the potential for the use of Ashwagandha standardized extract for treatment of Insomnia by assessment of the effect of Ashwagandha on sleep in healthy subjects and those with insomnia.
 
Close