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CTRI Number  CTRI/2012/06/002713 [Registered on: 04/06/2012] Trial Registered Retrospectively
Last Modified On: 28/02/2014
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A clinical study to evaluate the Safety of Jeevanprash (JP) in Healthy Individuals in Summer. 
Scientific Title of Study   An Open Labeled, Prospective, Single-center, Clinical Study to Evaluate the Safety of Jeevanprash (JP) in Healthy Individuals in Summer.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
AL/JP/01/2012  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vaishali Shailesh Deshpande  
Designation  Lecturer in Kayachikitsa 
Affiliation  Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune 28 
Address  Department of Kayachikitsa Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune

Pune
MAHARASHTRA
411028
India 
Phone  9096082950  
Fax    
Email  dr.vaishalid@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sanjay Tamoli 
Designation  Director 
Affiliation  Target Institute of Medical Education & Research 
Address  Target Institute of Medical Education & Research 2/A Blue Diamond Society Nayagaon Dahisar Mumbai

Mumbai (Suburban)
MAHARASHTRA
400068
India 
Phone  09322522252  
Fax    
Email  sanjaytamoli@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sanjay Tamoli 
Designation  Director 
Affiliation  Target Institute of Medical Education & Research 
Address  Target Institute of Medical Education & Research 2/A Blue Diamond Society Nayagaon Dahisar Mumbai

Mumbai (Suburban)
MAHARASHTRA
400068
India 
Phone  09322522252  
Fax    
Email  sanjaytamoli@hotmail.com  
 
Source of Monetary or Material Support  
Alkem Laboratories Ltd. Devashish Alkem House Senapati Bapat Marg Lower Parel Mumbai 400 013  
 
Primary Sponsor  
Name  Alkem Laboratories Ltd 
Address  Devashish Alkem House Senapati Bapat Marg Lower Parel Mumbai 400 013  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
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 Vaishali Shailesh Deshpande  Department of Kayachikitsa  Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune
Pune
MAHARASHTRA 
9096082950

dr.vaishalid@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Human Volunteers 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Jeevanprash Awaleha  Each 100 gm of Jeevanprash Awaleha contains: Sr. No. Ingredients Quantity 1 Amla 80g 2 Dashmool 4 g 3 Vanshlochan 0.5 gms 4 Bala, Mudagparni, Mashaparni, Karkatshiringi, Bhumiamlaki, Jivanti. Haritaki, Guduchi, Kachur, Mustak, Punarnava, Bramhi, Kamalphool, Kakanasa, Yashtimadhu, Varahikhand, Ashwagandha, Shatavari, Vidarikanda, Kumari (Aloe vera) and Adulsa Each 0.4 g 5 Elaichi 0.4 g 6 Pippali 0.4 g 7 Dalchini 0.2 g 8 Tejpata 0.2 g 9 Nagkesar 0.2 g 10 Lavang 0.2 g 11 Rose Petals 0.2 g 12 Abhrak Bhasma(Rastarangini) 0.2 mg 13 Fructo-Oligosacharide(FOS) q.s 14 Silver foil 10 mg 15 Contains permitted preservative Sodium benzoate Dosage and Duration: 10 gm daily with Lukewarm water for 28 days 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Subjects meeting all of the following criteria will be included to the trial-

• Males and Females, age group between 20-40 years
• Ready to provide written informed consent
• No significant diseases or clinically abnormal laboratory blood profiles during screening.
• ECG without significant abnormalities
• Be able to communicate effectively with study personnel
• No history of allergic conditions and is not on regular medical treatment
 
 
ExclusionCriteria 
Details  Subjects meeting any of the following criteria will be excluded from the trial-

• Any significant disease condition which would affect subject’s participation or compliance to study protocol
• History of allergic conditions
• History of autoimmune disorders
• History of HIV I & II, Hepatitis.
• History or presence of dyspepsia, gastric ulcer or duodenal ulcer.
• History of any psychiatric disorders.
• Intake of any medication within 14 days before the start of the study.
• Recent history of alcoholism (<2 years) or consumption of alcohol within 48 hours of receiving study medication.
• Smokers who cannot refrain from smoking during the study period.
• Presence of clinically significant abnormal laboratory results during screening.
• Pregnancy or not using appropriate means of contraception.
• History of drug addiction. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess the clinical safety of JP in healthy individuals in summer by assessing Vital signs & symptoms, General and systemic examinations   Baseline to 35 days 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the safety of JP in healthy individuals in summer by assessing

1). Tolerability of the study drug by the subject at the end of 28 days of study treatment.

2). Tolerability of the study drug by the investigator at the end of 28 days of study treatment.

3). Incidence, severity and duration of adverse event(s).

4). Laboratory investigations.
 
Baseline to 35 days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   23/05/2012 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="0"
Days="8" 
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)?  

Brief Summary  

After Ethics committee’s clearance for the clinical study, healthy individuals will be screened at Department of Kayachikitsa, Sumatibhai Shah Ayurved Mahavidyalaya and Hospital, Hadapsar, Pune. Those meeting inclusion criteria and ready to provide written informed consent will be recruited in the study. The treatment will be given on OPD basis. Considering 20% dropout rate, 36 healthy individuals will be recruited in the study to get 30 evaluable cases at the end of the study.

 On screening visit, a written informed consent will be obtained from subjects for their participation in the study. Subject will be inquired about presence of any disease and medication for the same. If subject is suffering from any disease, he/she will not be included in the study. Subject’s general (vital signs and symptoms) and systemic examinations will be done. Then subject will undergo laboratory investigations viz. CBC, ESR, Hb%, Blood Sugar Fasting, HIV, HbsAg, Liver profile, lipid profile, renal profile, Urine routine and microscopic and Urine pregnancy test (for females of fertile age). Subjects will also undergo X-ray chest PA view and ECG examinations.

A wash out period of 3 days will be given. During washout period and the whole study period (viz. 28 days + 7 days), subject will be advised to refrain from any medication (Ayurvedic, allopathic, homeopathic etc.) other than study medication i.e. Jeevanprash.

On baseline visit (Day 0), subjects will be recruited in the study if he/she meets all the inclusion criteria. Subject will be inquired about occurrence of adverse event. Subjects will then undergo general (including vital signs and symptoms) and systemic examinations. After the baseline visit, subjects will be called at OPD of Sane Guruji Aarogya Kendra hospital on 7th day, 14th day, 21st day, 28th day and 35th day of the treatment.

At baseline visit all subjects included in the trial will be provided with a Jar of Jeevanprash weighing 500 gm (280 grams for 28 days + 30 grams in case, if follow up is delayed maximum upto 3 days). All the subjects will be advised to consume 10 gm of Jeevanprash in the morning on empty stomach with lukewarm water daily for 28 days. After 28 days, the subjects will be asked to stop taking Jeevanprash and they will be observed for next 7 days for any adverse event. All subjects will be asked to give back the balance quantity of Jeevanprash on 28th day.

On every follow up visit, subjects will undergo general and systemic examination. Tolerability of the trial medicine will be assessed by the investigator and by the subject on day 28 and at the end of the study i.e. on day 35. Drug compliance will also be assessed by the investigator on every visit starting from first follow up visit till day 28. All the subjects will be closely monitored for any adverse events/ adverse drug reactions on every visit till the completion of the study.

On day 28, subjects will be advised to undergo laboratory investigations viz. CBC, ESR, Hb%, Blood Sugar Fasting, Liver profile, Lipid profile, Renal profile and Urine routine and microscopic. On last visit i.e. on day 35, all the subjects will be informed that the study visits are over and their further course of treatment will be decided by the investigator.

 
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