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CTRI Number  CTRI/2024/10/075385 [Registered on: 16/10/2024] Trial Registered Prospectively
Last Modified On: 29/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda
Preventive 
Study Design  Single Arm Study 
Public Title of Study   An Open Label, Single Arm Clinical Trials study to evaluate the safety and efficacy of Zandu Kesri Jivan to improve immunity, strength, stamina and energy. 
Scientific Title of Study   An open label, clinical study to evaluate the safety and efficacy of Zandu Kesri Jivan to improve immunity, strength, stamina and energy. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sandeep Sharma 
Designation  Principal Investigator  
Affiliation  Jindal Super Specility Hospital 
Address  BAMS Division, Room No 6, Ground Floor,

Bharatpur
RAJASTHAN
321001
India 
Phone  7290072455  
Fax    
Email  sharmadrsandeep28@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sandeep Yadav 
Designation  Director 
Affiliation  Manentia Research Private Limited  
Address  Room No 313, CT Department

Gautam Buddha Nagar
UTTAR PRADESH
201301
India 
Phone  7290072455  
Fax    
Email  syadav@manentiaresearch.com  
 
Details of Contact Person
Public Query  
Name  Sandeep Yadav 
Designation  Director 
Affiliation  Manentia Research Private Limited 
Address  Room NO 313, CT Department

Gautam Buddha Nagar
UTTAR PRADESH
210301
India 
Phone  7290072455  
Fax    
Email  syadav@manentiaresearch.com  
 
Source of Monetary or Material Support  
Emami Limited, R&D Healthcare Division 13 BT Road, Belgharia, Kolkata – 700056  
 
Primary Sponsor  
Name  Emami Limited 
Address  R&D Healthcare Division Emami Limited 13BT Road, Belgharia Kolkata - 700056 
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 Sandeep Sharma  Jindal Super Specility Hospital  BAMS Division Ground Floor
Bharatpur
RAJASTHAN 		 7290072455

sharmadrsandeep28@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Jindal Super Speciality Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M638||Disorders of muscle in diseases classified elsewhere. Ayurveda Condition: DAURBALYAM, (2) ICD-10 Condition:J069||Acute upper respiratory infection,unspecified. Ayurveda Condition: KASA-PURVARUPAM, (3) ICD-10 Condition:B338||Other specified viral diseases. Ayurveda Condition: PRATISYAYA-PURVARUPAM, (4) ICD-10 Condition:K299||Gastroduodenitis, unspecified. Ayurveda Condition: AJIRNA-ATISNIGDHA-PITASNEHANAM ASTHAPANAVYAPADAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Zandu Kesari Jivan, Reference: NA, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 20(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 1 Days, anupAna/sahapAna: Yes(details: Milk and Zandu Honey), Additional Information: one or two tea spoon on daily basis
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Subjects who meet all of the following criteria will be included in the study:
1) Age: 45 to 75 years (both inclusive) at the time of consent.
2) Sex: male and/or female.
3) Subject with physical weakness (Daurbalya), frequent illness (cold (Pratishyaya) and cough (Kasa)), fatigue (Thakan), poor cognitive health (Smriti daurbalya), poor digestive health (Ajirna)
4) Subjects should be willing and able to follow the study protocol to participate in the study.
5) Subject must be able to understand and provide written informed consent to participate in the study.
 
 
ExclusionCriteria 
Details  Subjects who meet any of the following criteria will be excluded in the study:
1) Subject with known sensitivity or contraindication to any of the ingredients of study medication
2) Presence of any chronic disease or illness in the past three months or any clinically significant on-going chronic medical illness e.g. Congestive cardiac failure, Hepatitis, Hypotensive episodes, etc.
3) Recent history of dehydration from diarrhea, vomiting or any other reason within a period of 24 hours prior to the study.
4) Participation in any similar clinical trial within the past 90 days with blood loss more than 450 mL.
5) An unusual diet, special diet, for whatever reason e.g. high protein diet, low sodium diet, for two weeks prior to receiving any test food and throughout subject’s participation in the study.
6) Pregnant or lactating females.
7) History of Hepatitis B or C virus.
8) Physician decision that involvement in the study is not in the subject´s best interest.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Zandu Kesri Jivan will be assessed in terms increase of subject immunity. Symptoms associated with general debility , Pathological Examination value
 		 Study duration - 60 days, A total of 60 adult, male and/or female subjects will be enrolled in the study, in order to get at least 50 evaluable subjects at the end of the study. Adult, male and/or female subjects between the ages of 45 to 75 years old (both inclusive) at the time of consent. 
 
Secondary Outcome  
Outcome  TimePoints 
50 subjects of either sex will be enrolled from screening passed subjects.
Zandu Kesri Jivan (ZKJ) (approximately 12 g) will be given orally two times a day approximately 12 hours (±1 hours) for 60 days to recruited subjects.
Observations will be recorded for each subject, after giving Zandu Kesri Jivan (ZKJ) (12 g) orally two times a day for 60 days, at the base line (Day 0 before medication), & at day 61 of study period for Pathological Examination: Routine blood investigations like Hemoglobin, Total Leucocyte Count (TLC), Differential Blood Count (DLC), Erythrocyte Sedimentation Rate (ESR), SGPT, SGOT, Urea, Creatinine.
Additionally, measurement of Fasting blood sugar (FBS) will be done on visit, day 0, day 14, day 28, day 49, day 61 & Day 76.
Along with this, questionnaire-based evaluation will also be done on the day 0, day 14, day 28, day 49, day 61 & Day 76.
 		 Safety of Zandu Kesri Jivan will be assessed in terms increase of subject immunity & adverse events reported by subjects or assessed by Investigator 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   22/10/2024 
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="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  		 Zandu Keshri Jivan îs an Ayurvedic proprietary product being marketed in India from more than five decades. Enriched with properties of chyawanprash, a well-known Rasayana, Ramayana is well known for maintaining physical and mental health, provide strength & stamina, helps in delaying the ageing process. Zandu kesari Jivan is developed to maintain health of elderly people. It helps to improve appetite, digestion, provides strength, and enhances immunity and cognitive function. 

Zandu kesari jivan contains ingredients Amalaki, Ashwangandha, Bala, Gokshur, Swet Musali, Jatiphal, Lavang,Marich, Pippali, Twak, Vanshlochan, Sunthi, Vidang and kesar. It also contains minerals like Yashad bhasma, Abharak Bhasma and Mukta Sukti Bhasma. These ingredients are helpful in providing strength, stamina, reduces stress and anxiety, improves digestion as well as cognitive function, supports bone and joint health and improves quality of life.
 
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