A Clinical Trial to study the effect of the Drug Akkini chooranam (Internal) and Veera mezhugu (external) in patients having pain in sole of the foot

Phase 2

Recruiting

• Conditions: Kuthikaal vaatham (Plantar fasciitis)

• Registration Number: CTRI/2017/06/008931
• Lead Sponsor: National Institute of Siddha

Brief Summary

It is a single, non-randomized, open-label trial to determine the efficacy and safety of AKKINI CHOORANAM  in patients with KUTHIKAAL VATHAM (PLANTAR FASCIITIS). In this trial 40 patients will be recruited and the trial drug will be administered 1.5 gm twice a day for a period of 48 days. During this trial period all the study related data will be recorded and documented in a page separate trial master file for each patients.During the trial period if any AE/SAE/SUSAR will be noticed and referred to pharmacovigilance dept.in NIS and further management will also be given in NIS OPD/IPD.The entire trial will be monitored by the research monitoring committee OF NIS. During this trial all the safety and efficacy parameters will be recorded in the CRF. After completion of the trial all the study related data will be analysed statistically .The out come of this trial will be published in Indian Journal of Medical Research

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-28
• Last Update Posted: 2017-06-06

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1.Pain and tenderness in the sole of the foot while on walking and standing.

Exclusion Criteria

1.H/o Cardiac diseases 2.H/o Diabetes mellitus 3.H/o Rheumatoid arthritis 4.H/o Chronic kidney disease 5.Pregnancy and lactation 6.Septic arthritis 7.Gonococcal arthritis 8.Psoriatic arthritis 9.Patient with any other serious systemic illness.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome of the study is pain relieving and it will be assessed by Universal Pain assessment scale (before and after treatment). Restricted movement assessment scale (before and after treatment) and Questionnaire.	48 days

Secondary Outcome Measures

Name	Time	Method
Reduction in Associated factors of Kuthikaal vaatham by Age, Sex, BMI and occupation.	NIL

Trial Locations

Locations (1)

Ayothidoss Pandithar Hospital; 🇮🇳 Chennai, TAMIL NADU, India

Ayothidoss Pandithar Hospital

🇮🇳Chennai, TAMIL NADU, India

Dr M Padmavathi

Principal investigator

9092146820

dr.padma90@gmail.com