Health Condition 1: M638- Disorders of muscle in diseases classified elsewhere Health Condition 2: J069- Acute upper respiratory infection,unspecified Health Condition 3: B338- Other specified viral diseases Health Condition 4: K299- Gastroduodenitis, unspecified
Conditions
Interventions
None listed
Sponsors
Emami Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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 subjectâ??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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Zandu Kesri Jivan will be assessed in terms increase of subject immunity. Symptoms associated with general debility , Pathological Examination value Timepoint: 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
| Measure | Time frame |
|---|---|
| 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. Timepoint: Safety of Zandu Kesri Jivan will be assessed in terms increase of subject immunity & adverse events reported by subjects or assessed by Investigator | — |
Countries
India
Contacts
Public ContactSandeep Yadav
Manentia Research Private Limited
Outcome results
None listed