A clinical trial on THAZUTHALAI ILAI CHOORANAM in the management of KUMBAVADHAM( PERIARTHRITIS)

Phase 2

Not yet recruiting

• Conditions: Adhesive capsulitis of shoulder,

• Registration Number: CTRI/2022/02/040038
• Lead Sponsor: Government Siddha Medical College and Hospital

Brief Summary

The study is a prospective open labelled non randomized phase II clinical trail on Thazhuthalai lllai chooranam in the management of Kumbavadham( Periarthritis). The trail drug will be administered at the dose of 2gm/Twice a day A/F for 45 days along with hot water adjuvant in 40 patients. The trail period of 12 months will be carrying out in Government Siddha  Medical College and Hospital, palayamkottai, Tirunelveli. The primary outcome will be evaluation of therapeutic efficacy of trail drug THAZHUTHALAI ILAI CHOORANAM.  The secondary outcome will be evaluation of siddha parameters, assessment of safety profile of trail drug, assessment of pharmacological and biochemical parameters of trail drug. In case any adverse event (AE)  is noticed and it will be referred to pharmacovigilence department of SCRI.  Further management of patient will be given in OPD facility.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-03-02
• Study Start: 2022-12-02

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1.Patient having main symptoms of shoulder pain, numbness, wasting in the shoulder region and arms, restricted movement of upperlimbs,loss of abduction and forward flexing, stiffness of the shoulder joint 2.Diabetes mellitus 3.patient willing for doing laboratory investigations and X ray, imaging.

Exclusion Criteria

• 1.Rheumatoid arthritis 2.
• Ischemical heart disease 3.Hypertension 4.
• Pregnancy and lactating mother 5.Recent shoulder dislocation 6.
• Sub acromial bursitis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
If during treatment or after treatment Redution of the signs and symptoms of	45 days
1.shoulder joint pain	45 days
2.shoulder stiffness	45 days
5.Radiating pain down arm	45 days
3.Inability to raise arm	45 days
4.Limited shoulder mobility and wasting in shoulder region and arms and numbness	45 days
6.Restricted movements of upperlimbs.	45 days
7. Loss of abduction and forward flexing and external rotation and achieving better Oxford shoulder score (40-48)	45 days

Secondary Outcome Measures

Name	Time	Method
1. To evaluate the biochemical physico-chemical analysis of clinical trail drug	2. To evaluate the antimicrobial activity of trail drug

Trial Locations

Locations (1)

Government Siddha Medical College and Hospital; 🇮🇳 Tirunelveli, TAMIL NADU, India

Government Siddha Medical College and Hospital

🇮🇳Tirunelveli, TAMIL NADU, India

Dr M Mani bharathi

Principal investigator

9751982937

manibharathibsms@gmail.com