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CTRI Number  CTRI/2011/091/000222 [Registered on: 17/02/2011]
Last Modified On: 20/02/2013
Post Graduate Thesis   
Type of Trial   
Type of Study    
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Study of efficacy and safety of KSM-66 Ashwagandhaa (Withania somnifera Dunal) in stress and anxiety and on general well being in healthy adults. 
Scientific Title of Study   A Single Centre, Prospective, Randomized, Double-blind Placebo Controlled Study of Safety And Efficacy of KSM-66 in Healthy Adults. 
Secondary IDs if Any  
Secondary ID  Identifier 
IX-KSM-66-01/04  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr.K.Chandrasekhar 
Designation   
Affiliation   
Address  Asha Hospital, 298, Road no.14,
Banjara Hills
Hyderabad
ANDHRA PRADESH
500001
India 
Phone  04023546538  
Fax  04023546538  
Email  kcsekhar56@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr.Shridhar Anishetty 
Designation   
Affiliation   
Address  Ixoreal Biomed Private Limited, 3rd floor, Sanali estate, Chirag ali lane, abids
Hyderabad
Hyderabad
ANDHRA PRADESH
500001
India 
Phone  04064513818  
Fax  04023204386  
Email  shridhar_anishetty@ixoreal.com  
 
Details of Contact Person
Public Query
 
Name  Dr.Shridhar Anishetty 
Designation   
Affiliation   
Address  Ixoreal Biomed Private Limited, 3rd floor, Sanali estate, Chirag ali lane, abids
Hyderabad
Hyderabad
ANDHRA PRADESH
500001
India 
Phone  04064513818  
Fax  04023204386  
Email  shridhar_anishetty@ixoreal.com  
 
Source of Monetary or Material Support  
Ixoreal Biomed Private Limited, #5-9-225, 3rd Floor, Sanali estate, Chirag ali lane, Abids, Hyderabad, Andhra Pradesh ? 500001. India. 
 
Primary Sponsor  
Name  Ixoreal Biomed Priavte Limited, #5-9-225, 3rd floor, Sanali estate, Chirag ali lane, Abids, Hyderabad, Andhra Pradesh- 500001, India 
Address   
Type of Sponsor   
 
Details of Secondary Sponsor  
Name  Address 
NIL   
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.Jyoti Kapoor  Asha hospital, 298, Road no.14, Banjara hills  Hyderabad,Hyderabad-500034
Hyderabad
ANDHRA PRADESH 
04023542838
04023546538
kapoor_jyoti@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics committee, Asha Hospital, Hyderabad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
  Stress, Anxiety and General wellbeing 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  ksm66 ashwagandhaa  250 mg orally BID for 8 weeks 
Comparator Agent  Placebo  same 
 
Inclusion Criteria  
Age From   
Age To   
Gender   
Details  ? Healthy adults of either sex, who are facing routine work stresses, who sign the Informed Consent Form. ? Age group 18 -54 years ? Can read , write and understand English ? Subjects with WHO-5 well being index < 15 or PSS scores >14  
 
ExclusionCriteria 
Details  ? Suffering from any chronic physical, hormonal or psychiatric illness ? Current substance dependence ? Individuals refusing to use appropriate non-hormonal birth control measures. ? Pregnancy / lactating mothers ? Currently taking any other medication on a regular basis ? Currently taking any herbal preparations (other formulations containing ashwagandha / ginseng / ginkgo biloba / brahmi etc) ? Clinically significant findings on laboratory investigations and ECG  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Total score on DASS and GHQ-28 after 8 wk  0 day, 60 day 
 
Secondary Outcome  
Outcome  TimePoints 
Comparison of the study and control group on PSS scores Comparison of the study and control groups on various laboratory measures and serum cortisol levels Comparison of the study and control group on PSS scores Comparison of the study and control groups on various laboratory measures and serum cortisol levels   0 day and 60 day 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="" 
Phase of Trial   Phase 1/ Phase 2 
Date of First Enrollment (India)   No Date Specified 
Date of First Enrollment (Global)  16/09/2010 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Open to Recruitment 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Brief Summary   It is a single centre, prospective, randomized, double blind, placebo controlled study of safety and efficacy of KSM-66 in reducing stress and anxiety and on general well being in health adults. Not more than 70 subjects will be recruited for the study and randomized to placebo and control groups. The primary efficacy measure is the scores on DASS and GHQ-28 at the end of 8 weeks. The secondary outcomes are scores on Perceived Stress Score at the end of 8 weeks and laboratory values for Thyroid Function Test, Lipid Profile, Hematology, Liver Function Test and serum cortisol level as a marker for stress. The study is also designed to explore effect on individual symptom groups of stress, anxiety and depression on DASS and somatic symptoms, anxiety/insomnia, social dysfunction and depression on GHQ-28. 
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