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CTRI Number  CTRI/2011/11/002130 [Registered on: 16/11/2011] Trial Registered Prospectively
Last Modified On: 19/07/2012
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A study to evaluate the Efficacy of E-IN-05 in subjects of Primary Insomnia  
Scientific Title of Study   An Exploratory, Open Label study to evaluate the Efficacy of E-IN-05 in subjects of Primary Insomnia  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
EB-EIN-03-11  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query  
Name  Dr Shalini Shrivastava 
Designation  Sr. Project Manager 
Affiliation  Enovate Biolife Pvt. Ltd. 
Address  203, Morya Landmark 1, Off. New Link Road, Andheri (West)

Mumbai
MAHARASHTRA
400053
India 
Phone  022-42172327  
Fax  022-66941179  
Email  shalini@enovatebiolife.com  
 
Details of Contact Person
Public Query  
Name  Seema Damakale 
Designation  Asst. Project Manager 
Affiliation  Vedic Lifesciences Pvt. Ltd. 
Address  B-118, Morya House, Off. New Link Road, Andheri (West)

Mumbai
MAHARASHTRA
400053
India 
Phone  022-42025711  
Fax  022-66941179  
Email  seema.d@vediclifesciences.com  
 
Source of Monetary or Material Support  
Enovate Biolife Pvt. Ltd. 
 
Primary Sponsor  
Name  Enovate Biolife Pvt Ltd 
Address  203, Morya Landmark 1, Off. New Link Road, Andheri (West), Mumbai - 400053 
Type of Sponsor  Other [Nutraceutical Research] 
 
Details of Secondary Sponsor  
Name  Address 
Vedic Lifesciences Pvt Ltd  B-118, Morya House, off. New Link Road, Andheri (West), Mumbai - 400053 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Umesh Nagapurkar  Dr. Nagapurkars Clinic  Malpani Pride, Near Raymond Showroom, Sharanpur Road, Nasik - 422002
Mumbai
MAHARASHTRA 		 9823146088

uncleumesh@gmail.com 
Dr Devendra Save  Harmony D Wellness Clinic  Ganjawala Enclave, Ground Floor, Ganjawala Lane, Borivali (West), Mumbai - 400092
Mumbai
MAHARASHTRA 		 9892255888

devendrasave@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Independent Ethics Committee - Aditya (Dr. Devendra Save)  Approved 
Independent Ethics Committee - Aditya (Dr. Umesh Nagapurkar)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Primary Insomnia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  E-IN-05  Each Capsule contains: Hypericum perforatum - 100 mg Nardostachys grandiflora - 100 mg Celastrus paniculatus - 75 mg Magnesium - 200 mg Zinc - 40 mg Dosage: 2 Caps at night with a glass of water for 42 days 
Comparator Agent  None  Not Applicable 
 
Inclusion Criteria  
Age From  24.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  - Case of primary Insomnia as diagnosed by the investigator
- Sleep disorder indicated by one or more of the following:
- History of sleep duration of less than 4.5 hrs/ night
- History of sleep latency of ≥ 60 min
- History of tiredness post awakening
- History of presence of above symptoms for ≥ 6 months.
- Able and willing to follow all study related instructions and to make all required visits
 
 
ExclusionCriteria 
Details  - Subjects not willing to discontinue insomnia medication
- Secondary forms of insomnia
- Concurrent history/ treatment of acute psychiatric illness (such as schizophrenia, acute panic attack, major depressive disorder etc.).
- Subjects with history of a substance use disorder
- History of uncontrolled diabetes, hypertension and other metabolic disorder.
- Clinical history of allergy/ hypersensitivity to one or more products of herbal origin.
- Pregnant / lactating women and women who are planning to get pregnant
- Recent (within last 3 months) participation in a clinical trial
- Recent (within last 15 days) use of any, herbal or homeopathic product for the insomnia.
- A medical condition, which in the Investigator’s opinion may pose a threat to patient compliance e.g. case of seizures.
- Subjects otherwise judged by the investigator or sub -investigator to be inappropriate for inclusion in the study
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
• Increase in sleep duration by 1-2 hrs/ day as assessed by patient’s sleep dairy  • Increase in sleep duration by 1-2 hrs/ day as assessed by patient’s sleep dairy 
 
Secondary Outcome  
Outcome  TimePoints 
1) Decrease in sleep latency
2) Modified Pittsburgh Sleep Quality Index
 		 1) Day 0, Day 21 and Day 42
2) Day 0, Day 21 and Day 42 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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 1/ Phase 2 
Date of First Enrollment (India)   30/11/2011 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Other (Terminated) 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   The objective of this study is to evaluate the safety and efficacy of E-IN-05 in subjects with Primary Insomnia. Total 2 sites (one in Mumbai and one in Nasik) have been finalized for the study. Total 20 subjects will be recruited to get 16 completed cases. The total study duration is 42 days with the follow up visits at the interval of 21 days.  
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