Efficacy of Vatantak Gold Tablet and Pain Kill Oil in painful inflammatory Musculoskeletal Conditions

Not Applicable

Not yet recruiting

Conditions: Other symptoms and signs involvingthe nervous and musculoskeletal systems. Ayurveda Condition: VATAVYADHIH,

Brief Summary: Post-marketing open labelobservational clinical study will be undertaken under investigator and his team in Kolkata at 2 sites. Total no. of study patients 60+10% dropouts. Only those patients providing written informed consent will be enrolled for the study in specific study centre. After receiving the written consent, all patients will be assessed according to inclusion and exclusion criteria, and then will be enrolled. Study materials will be provided to them free of cost for their regular use, along with specific information. Patients need to apply locally Pain Kill Oil twice daily and oral intake of Vatantak Gold Tablet - 2 tablet twice daily before food with milk or lukewarm water for 60 days. Diet habit/ life style modification will also be guided. The patients will visit their specific centre at baseline and at end of the study for assessment. Statistical analysis will be done according to type of data and significance will be considered p= less than 0.05.

Recruitment & Eligibility

Inclusion Criteria

1.Patients 18 years or older, with musculoskeletal pain.
2.Patients willing to give written informed consent.
3.Patients are fit and no need for any hospital administration.
4.Agree to following instruction of doâ€™s and donâ€™ts in regular daily lifestyle.
5.Patients willing to perform all study related procedures including the use of study medicine, allow the physical and Biochemical tests and willing to document symptoms and medication.

Exclusion Criteria

1.Use of steroids and/or recreational drugs in the past 6 months.
2.Patients with open wounds or infection at the application site.
3.Patients with renal impairment.
4.Patients will be also excluded if they have poorly controlled diabetes mellitus.
5.Female patients who are pregnant.
6.Unstable medical or psychiatric illness.
7.Chronic & acute disorders requiring hospital admission.
8.Known HIV-positive, Hepatitis B or C status.
9.Inability to carry out visits for the study.
10.Inability to maintain current medication regimen.
11.Inability or unwillingness to participate in all components of the study.

Primary Outcome Measures

Name	Time	Method
1.Pain Score (VAS and NPRS)	At baseline and after 60 days of treatment
2.Disease activity based on questionnaires(QoL)	At baseline and after 60 days of treatment
3.Blood tests: ESR, RA factor, CRP, Serum Uric Acid	At baseline and after 60 days of treatment
(At baseline and after 60 days of treatment)	At baseline and after 60 days of treatment

Secondary Outcome Measures

Name	Time	Method
1.Quality of Life	2.Drug safety: RFT & LFT

Locations (2): Gananath Sen Institute of Ayurvidya and Research
🇮🇳
Kolkata, WEST BENGAL, India
The Ayurveda Clinic and Research Centre
🇮🇳
Kolkata, WEST BENGAL, India
Gananath Sen Institute of Ayurvidya and Research
🇮🇳Kolkata, WEST BENGAL, India
Dr Parikshit Debnath
Principal investigator
9836675720
docdebnath84@gmail.com