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Clinical Trials/CTRI/2020/03/024263
CTRI/2020/03/024263Not yet recruitingPhase 3 4

Effectiveness of Valuka Sveda as Tapa and Ushma Methods in Frozen Shoulder Of Diabetes Mellitus - A Pragmatic Comparative Trial

VPSV Ayurveda College Kottakkal1 site in 1 country36 target enrollmentStarted: March 30, 2020Last updated:
Conditions

Trial Snapshot

Phase
Phase 3 4
Status
Not yet recruiting
Sponsor
Enrollment
36
Locations
1
Primary Endpoint
2.Goniometry

Study Overview

Brief Summary

Frozen shoulder or Adhesive Capsulitis is a clinical syndrome characterised by painful restriction of both active and passive movements of shoulder. It is considered as one of the most common cause of shoulder in which females are more affectedI. it is having an incidence of 2% in general population and 10-30% in Diabetes mellitus patients. Valuka is an important, easy and effective material for ruksha sveda, and is mentioned under both tapa and ushma sveda in classics.In this study, Valuka sveda as Tapa is being compared with Ushma Valuka sveda (by dipping the pottali in heated Dhanyamla) for assessment of effectiveness in Frozen shoulder of Diabetes mellitus. Cases will be diagnosed with specialised structured case proforma. Patents are then randomly allocated into two groups where one group receives Tapa valuka sveda and another group receives Ushma valuka sveda up to Vyadhi samana or maximum 14 days. Daily monitoring will be done. For vyadhi samana, SPADI will be assessed before commencement of course of  treatment, on each day after treatment, after completion of course, and after follow up. and Goniometry will be assessed before course of treatment, after course and after follow up. Sveda karmukatha will be assessed using an Event Evaluation Scale prepared by compiling all Samyak yoga, Ayoa and Atiyoga features of svedana and recording them on each day of intervention. Data will be collected and statistically analyse for the conclusion.

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Not Applicable

Eligibility Criteria

Ages
40.00 Year(s) to 70.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •Having clinical features of stage 2 and 3 of Frozen Shoulder Fit for Svedana karma Participants Who have given informed consent.

Exclusion Criteria

  • •1.History of trauma to shoulder 2.History of surgery on the particular shoulder 3.clinical findings of Rotator cuff lesion 4.Any neurological condition affecting shoulder 5.FBS value more than 200 6.Any other known cases of systemic illness 7.Pregnant and Lactating women.

Outcomes

Primary Outcomes

2.Goniometry

Time Frame: 1.Immediately after completion of treatment | 2.15 days after completion of treatment

1.SPADI

Time Frame: 1.Immediately after completion of treatment | 2.15 days after completion of treatment

3.Event Evaluation Scale for svedakarmukata

Time Frame: 1.Immediately after completion of treatment | 2.15 days after completion of treatment

Secondary Outcomes

  • 1.SPADI(2.Goniometry)

Investigators

Sponsor
VPSV Ayurveda College Kottakkal
Sponsor Class
Other [Aided Ayurveda medical college]

Study Sites (1)

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