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
|
|
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
|
|
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. |