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Clinical Trials/CTRI/2024/10/075183
CTRI/2024/10/075183Not yet recruitingPhase 2

A Randomized comparative clinical study of Matra Basti and Nasya Karma With Dashamoola Taila in the management of Avabahuka W.S.R to Frozen Shoulder.

Dr Deepa Patil1 site in 1 country40 target enrollmentStarted: October 24, 2024Last updated:

Trial Snapshot

Phase
Phase 2
Status
Not yet recruiting
Sponsor
Enrollment
40
Locations
1
Primary Endpoint
Changes in Bahu praspanditahara, Amsa sandi shoola is reduced, Amsa shosha is reduced, Stambha is reduced with Dashamoola Taila

Study Overview

Brief Summary

A RANDOMIZED COMPARATIVE CLINICAL STUDY OF MATRA BASTI AND NASYA KARMA WITH DASHAMOOLA TAILA IN THE MANAGEMENT OF AVABAHUKA W.S.R. TO FROZEN SHOULDER.

OBJECTIVES OF THE STUDY :

a) To study the effect of Matra Basti in Avabahuka with Dashamoola taila.

b) To Study the effect of Nasya Karma in Avabahuka with Dashamoola taila.

c) To Study and compare the effect of Matra Basti and Nasya Karma in Avabahuka with Dashamoola Taila.

METHODS AND MATERIALS :

SOURCE OF DATA

a) Literary Source - Ayurvedic classics and textbooks

Modern Medical books

Articles published from journals and Magazines

Related data Source from Website

b) Clinical Source - Patient of either sex attending OPD and IPD department of Panchakarma of S.S.R.A.M College and Hospital Inchal, Belagavi, Karnataka

c) Drug Source - All the drugs are collected from local areas, market and medicine will be prepared in S.S.R.A.M Pharmacy Inchal as per classics.

METHODS OF COLLECTION OF DATA :

A special proforma will be prepared with all points of History taking, Physical signs and Symptoms as mentioned in Ayurveda and accordingly. Selected patients will be subjected to detailed clinical history and complete physical examination.

A) DESIGN OF THE STUDY (INTERVENTION) :

It is a randomized comparative clinical study. The patients will be selected irrespective of sex, caste, race based on the diagnostic inclusion and exclusion criteria.

The selected patients will be randomly grouped  into two groups of 20 each. After intervention the results obtained will be statistically analyzed.

GROUP A - 20 Patients will be administered Matra Basti.

GROUP B - 20 Patients will be administered Nasya Karma.

Treatment duration - 7 days

Total duration of study - 15 days

Assessment will be done on - Before treatment and 7th day

Follow up will be done on - 15th day

B) DIAGNOSTIC CRITERIA :  Bahu Praspanditahara

Amsa sandi shoola

Amsa shosha

Stamba

X-ray

a)  Inclusion criteria : Patient fit for Basti and Nasya Karma

Patient of either sex

Patient with clinical feature of Avabahuka

Age group 16-60yrs

b) Exclusion criteria : Patient unfit for basti and Nasya karma

Patient with history of fracture and dislocation

Patient below 16yrs and above 60yrs

Patient with systemic illness

Pregnant and lactating mother

PARAMETERS OF STUDY :

a) Subjective parameters :  Bahu Praspanditahara

Amsa Sandi Shoola

Stambha

Amsa Shosha

b) Objective parameters : Swelling

Tenderness

Sandi  Graham (Goniometer reading) : Forward flexion

Hyper extention

Abduction

Internal rotation

External rotation

INVESTIGATION : CBC

RBS

X-Ray of affected Sandhi

ASSESSMENT CRIETERIA : A detailed profoma will be prepared for the assessment of subjective and objective parameters by grading them. The data obtained will be analyzed statistically with suitable method.

Study Design

Study Type
Interventional
Allocation
Na
Masking
None

Eligibility Criteria

Ages
16.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patients with either sex between the age group 16 to 60 yrs with Bahu praspanditahara, Amsa sandi shoola, Amsa shosha, Stambha are selected.

Exclusion Criteria

  • Patient unfit for basti and Nasya karma, with history of fracture and dislocation, below 16 yrs and above 60 yrs, with systemic illness, pregnant and lactating mother.

Outcomes

Primary Outcomes

Changes in Bahu praspanditahara, Amsa sandi shoola is reduced, Amsa shosha is reduced, Stambha is reduced with Dashamoola Taila

Time Frame: 1 week

Secondary Outcomes

  • Changes in Bahu praspanditahara, Amsa sandi shoola, Amsa shosha,Stambha(After 7 days treatment)

Investigators

Sponsor
Dr Deepa Patil
Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Dr Deepa Patil

SSRAMC,Inchal

Study Sites (1)

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