Clinical Study to Evaluate Efficacy and Safety of Zandu ultra power balm in subjects suffering from headache, cold, body ache, muscle pain and joint pain

It is a clinical study to evaluate efficacy and safety of Zandu ultra power balm in subjects suffering from headache, cold, body ache, muscle pain and joint pain. The study will be carried out at 1-2 centres in India. There will be two cohorts. In cohort 1, subjects suffering from cold symptoms, headache and body ache will be recruited. In cohort 2, subjects suffering from muscle and joint pain will be recruited. In Cohort 1, subjects will be asked to apply Zandu Ultra Power balm on forehead, nose, paranasal sinuses area, throat and chest three times daily for 7 days. and in Cohort 2, subject will be asked to apply sufficient quantity of assigned product on the affected part two times daily for 30 days.

Cohort 1: In Primary objectives of the study will be to assess change in cold symptoms i.e. nasal block, cough, headache, sore throat, runny nose, body ache and number and percentage of participants who report complete relief in headache, cold and body ache. Secondary objectives of the study will be to assess satisfaction of the quality of sleep, requirement of rescue medications, skin patch test, global assessment for overall change by participants and by physician and adverse events, adverse drug reactions including vitals

 Cohort 2: Primary objective of the study will be to assess change in joint and muscle pain on VAS scale. Secondary objectives of the study will be to assess requirement of rescue medications, skin patch test, onset of action of Zandu ultra power balm as pain relief, duration of action of the Zandu ultra power balm as pain reliever, global assessment for overall change as assessed by participants and investigator and tolerability of study medications as assessed by participants and investigator on Baseline Visit, Visit1 (24hrs), Visit 2 (48hrs), Visit 3 (Day 3), Visit 4 (Day 7)