A Clinical Study to Assess the Safety and Effectiveness of Dharasana Lep in Patients With Mild to Moderate Muscular, Joint, or Rheumatic Pain

Prior treatment

• Subject has severe arthritis requiring prescription medication including immunomodulators, COX Inhibitors, etc.

Other illness

• Subjects having any skin disorder or presence of open wounds, cut, bruising, rashes etc.
• Subjects suffering from auto-immune disorder, spastic disorder, genetic disorder and any other sever traumatic conditions.
• Subject have history of any hypersensitivity to the ingredients in the Lep.
• Subject who had taken any systemic product for any illnesses for at least 3 months.
• History of alcohol or drug addiction.
• History of chronic illness which may influence the cutaneous state.

Other

• Subjects with raw wounds, sutures, fractures and hematoma.
• Subjects with chronic pain like arthritis, gout, and ankylosing spondylitis.
• Pregnant or breast feeding or planning to become pregnant during the study period.
• Subject have participated any clinical research study within the last 30 days.

• Age: 25-65 years (both inclusive) at the time of consent.
• Sex: Males and non-pregnant/non-lactating females (preferably equal number of males and females).
• Subject is in good general health as determined by the Investigator on the basis of medical history.
• 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.
• Patients must have a confirmed diagnosis of mild to moderate musculoskeletal pain and rheumatic conditions with a pain score between 4 - 7, grade will be evaluated using Visual Analog Scale (VAS).
• 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.
• 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.
• Subjects are willing to give written informed consent and are willing to follow the study procedure.
• 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.
• Subject is willing and able to comply with study procedures, including all scheduled visits, treatment applications, and assessments.
• Subject is willing and able to follow the study directions, to participate in the study, returning for all specified visits.
• Subject must be able to understand and provide written informed consent to participate in the study.