Health Condition 1: M255- Pain in joint
Conditions
Interventions
None listed
Sponsors
Shah Maganlal Chunilal Gandhi
Eligibility
Inclusion criteria
Inclusion criteria: 1) Age: 25-65 years (both inclusive) at the time of consent. 2) Sex: Males and non-pregnant/non-lactating females (preferably equal number of males and females). 3) Subject is in good general health as determined by the Investigator on the basis of medical history. 4) Subject must be having presence of body ache, joint or muscle pain, sprain/strain, or back pain for more than 1 week and less than 6 months. 5) Patients must have a confirmed diagnosis of mild to moderate musculoskeletal pain and rheumatic conditions with a pain score between 4 to 7, grade will be evaluated using Visual Analog Scale (VAS). 6) Subject is able to remain on stable doses of contraceptive or replacement hormonal therapy, including no therapy, 6 weeks prior to and for the duration of the study. 7) If the subject is of childbearing potential they must have a self-reported negative urine pregnancy, is practicing and agrees to maintain an established method of birth control (IUD, hormonal implant device/injection, regular use of birth control pills or patch, diaphragm, condoms with spermicide or sponge with spermicidal jelly, cream or foam, partner vasectomy or abstinence). Females will be considered as non-childbearing potential if they are surgically sterile, have been post-menopausal for at least 1 year or have had a tubal ligation. 8) Subjects are willing to give written informed consent and are willing to follow the study procedure. 9) Subjects who commit not to use any other medicated/ prescription topical analgesics or medication, other than the test treatment for the entire duration of the study. 10) Subject is willing and able to comply with study procedures, including all scheduled visits, treatment applications, and assessments. 11) Subject is willing and able to follow the study directions, to participate in the study, returning for all specified visits. 12) Subject must be able to understand and provide written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1) Subject has severe arthritis requiring prescription medication including immunomodulators, COX Inhibitors, etc. 2) Subjects having any skin disorder or presence of open wounds, cut, bruising, rashes etc. 3) Subjects with raw wounds, sutures, fractures and hematoma. 4) Subjects suffering from auto-immune disorder, spastic disorder, genetic disorder and any other sever traumatic conditions. 5) Subjects with chronic pain like arthritis, gout, and ankylosing spondylitis. 6) Subject have history of any hypersensitivity to the ingredients in the Lep. 7) Subject who had taken any systemic product for any illnesses for at least 3 months. 8) History of alcohol or drug addiction. 9) Pregnant or breast feeding or planning to become pregnant during the study period. 10) History of chronic illness which may influence the cutaneous state. 11) Subject have participated any clinical research study within the last 30 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To evaluate the effectiveness of the test treatment by assessing the change in pain intensity i.e. knee pain, swelling, back pain, muscle pain, sprains and strains from baseline before application of test treatment to post removal of test treatment.Timepoint: Day 01, Day 02 and Day 04(2 Days) | — |
Secondary
| Measure | Time frame |
|---|---|
| 2. To evaluate the effectiveness of the test treatment by assessing change in flexibility/extent of movement of joint from baseline before application of test treatment to post removal of test-treatment.Timepoint: Day 01 and Day 04;3. To evaluate the effectiveness of the test treatment by assessing the change in Vedana (pain) from baseline before application of test treatment to post removal of test-treatment.Timepoint: Day 01 and Day 04;4. To evaluate the effectiveness of the test treatment by accessing the change in ayurvedic clinical examination from baseline before application of test treatment to post removal of test-treatmentTimepoint: Day 01 and Day 04;5. To evaluate the effectiveness of the test treatment by assessing change in product perception questionnaire, and PGIC questionnaire from baseline before application of test treatment to post removal of test treatment.Timepoint: Day 01 and Day 04;1. To evaluate the effectiveness of the test treatment by assessing change in joint stiffness and movement from baseline before application of test treatment to post removal of test-treatmentTimepoint: Day 01 and Day 04 | — |
Countries
India
Contacts
Public ContactMaheshvari N Patel
NovoBliss Research Private Limited
Outcome results
None listed