None listed
Conditions
Interventions
Intervention1: Acidum boswellicum prepared from Boswellic acid (BA), a phytoconstituent of Boswellia serrata.: 6CH and 30CH in ascending order in two cycles. 12 doses: each dose of 4 pills (Size 30).
Sponsors
Dr. Willmar Schwabe India Pvt. Ltd. (SCHWABE INDIA)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Males and non-pregnant, non-lactating females between 18-60 years of age; both inclusive at the first time of signing the Informed Consent Form. 2. Body mass index (BMI) between 18.5 kg per m2 to 24.9 kg per m2, inclusive for subjects calculated as (weight in kg) divided by (height in m)2 and Weigh at least 50 kg. 3. Willing and able to provide written informed consent prior to any study specific procedures being performed. 4. Healthy individuals with no apparent disease and normal or clinically not Significant routine laboratory parameters during screening. 5. Judged by the Investigator to be in good health as documented by the medical history, Physical examination (including but may not be limited to an evaluation of the cardiovascular, gastrointestinal, respiratory, and central nervous system), vital signs assessment, 12 lead electrocardiogram (ECG), USG Abdomen, Clinical laboratory assessments and by general observations. Any abnormality or deviations outside the normal ranges for any of the clinical testing (laboratory tests, ECG, vital signs, USG Abdomen) can be repeated at the discretion of the investigator and judged to be not clinically significant for subject. 6. Intelligent enough, as judged by the investigator, to carefully record the facts, subjective and objective symptoms generated by the drug during proving. 7. Subject is willing to be available for the entire study period and to adhere to protocol requirements as evidenced by signing informed consent document. 8. Completed the screening process within 07 days prior to enrolment in the study.
Exclusion criteria
Exclusion criteria: 1. Pregnant and Lactating women. 2. Reports any presence or history of a clinically significant disorder involving the cardiovascular, respiratory, renal, urologic, gastrointestinal, hepatic, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease or any other body system as determined by the investigator. 3. Presence of any clinically significant results from laboratory tests, vital signs assessments, and electrocardiograms, as judged by the investigator. 4. Subjects with colour blindness. 5. Subjects who have undergone surgery in the last two months. 6. Planned medical or dental treatment during the proving period including herbal or dietary supplements, procedures, or medications that are likely to interfere with, or substantially alter, responsiveness to the proving substance. 7. Subjects on regular medication (Allopathic, Ayurvedic, Homoeopathic, Naturopathic, Unani, etc.) for any acute or chronic disease. 8. Subjects on any homoeopathic remedy in the preceding one month and have had no significant change in health status in last one month (1 month prior to enrolment in the study). 9. Emotionally disturbed, hysterical, or anxious persons. 10. Reports history of clinically significant allergies including food or drug allergies. 11. Women who have undergone hysterectomy. 12. Reports smoking of more than 10 cigarettes per day, use of more than 4 packets per day of tobacco products or use of nicotine products (patches, gums, etc.) corresponding to more than 10 cigarettes per day or who are unable to abstain from smoking during the participation in the study. 13. Reports history of alcohol or drug addictions or unlikely to refrain from excessive alcohol consumption or drug intake during the study period. 14. Participation in another clinical or proving trial during the last 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Documentation of symptoms generated during the proving phase, with the endpoint defined as the disappearance of these symptoms and a subsequent symptom free period of 30 days.Timepoint: Cycle 1 - 30 Days and Cycle 2 - 30 Days | — |
Secondary
| Measure | Time frame |
|---|---|
| NilTimepoint: Nil | — |
Countries
India
Contacts
Public ContactMr Pravinkumar Pal
CLINICA Research Solutions LLP
Outcome results
None listed