Evaluating the efficacy of Ekangaveera Ras over Trayodashanga Guggulu after Karpasasthyadi Taila Nasya in the management of Avabahuka (Frozen Shoulder Disorder)- A Randomised controlled clinical trial

Research question

Whether Ekangaveera Ras is efficacious compared to Trayodashanga Guggulu in improving Range of Motion (ROM) and reducing pain of the shoulder joint in Avabahuka (Frozen Shoulder Disorder) patients after Karpasasthyadi Taila Nasya?

Null Hypothesis (H0)

There is no significant difference in the therapeutic efficacy of Trayodashanga Guggulu and Ekangaveera Ras after Karpasasthyadi Taila Nasya.

Alternate Hypothesis (H1)

There is significant difference in the therapeutic efficacy of Trayodashanga Guggulu and Ekangaveera Ras after Karpasasthyadi Taila Nasya.

AIM

To comparatively evaluate the efficacy of Ekangaveera Ras versus Trayodashanga Guggulu, when administered following Karpasasthyadi Taila Nasya, in the management of Avabahuka (Frozen Shoulder Disorder).

INCLUSION CRITERIA

1. Subjects aged between 31 and 60 years (irrespective of sex, socio-economic status) fulfilling the diagnostic criteria for Avabahuka [ICD 11 TM2 – Frozen Shoulder Disorder (SP15)].
2. Subjects with a clinical diagnosis of Primary Frozen Shoulder Disorder/ primary adhesive capsulitis of the shoulder joint.
3. Diabetic individuals with frozen shoulder, provided their blood glucose levels are well-controlled (e.g., specifying HbA1c less than 8.0% or fasting plasma glucose less than 140 mg/dL, and post-prandial plasma glucose less than 250 mg/dL).
4. Patients deemed fit for Nasya Karma.
5. Patients willing to sign the consent form for the clinical study.

EXCLUSION CRITERIA:

1. Subjects with a history of fracture or dislocation of the shoulder joint.
2. Subjects diagnosed with Secondary Frozen Shoulder Disorder /secondary adhesive capsulitis of the shoulder joint (e.g., due to trauma, surgery, or other identifiable systemic diseases that are the direct cause).
3. Patients with contraindications to Nasya Karma.
4. Subjects suffering from any other systemic disorders (e.g., active malignancy, severe cardiac/renal/hepatic disease) that could interfere with the course of intervention or compromise patient safety.
5. Patients with uncontrolled diabetes mellitus
6. Pregnant women and lactating mothers.
7. Subjects currently enrolled in any other clinical trial or receiving other concurrent treatments for frozen shoulder that could interfere with study outcomes.
8. Patients with known hypersensitivity or allergy to any of the study medications (Karpasasthyadi Taila, Ekangaveera Ras, Trayodashanga Guggulu).

POSOLOGY

Both Group A and B

GROUP A

GROUP B

|DRUG

Karpasasthyadi taila Nasya karma

Ekangaveera Ras

Trayodashanga Guggulu

|FORM

Oil (Taila)

Tablet (Vati)

Tablet (Vati)

|DOSE

8 Bindu (~4ml), each nostril

250mg BD

500 mg BD

|MODE OF ADMINISTRATION

Nasal

Oral after breakfast, and dinner.

Oral after breakfast, and dinner.

|ANUPANA

 Luke warm water

Luke warm water

|DURATION

1 week (7days)

4 weeks (28 days)

4 weeks (28 days)

|NUMBER OF PATIENTS

66

33

33

DURATION OF STUDY

·       Nasya administrationperiod                           -1 week(7days)

·       Oral Medication Period                                  -4 weeks(28days)

·       Follow Up Period                                           -4 Weeks(28days)

·       Review Period                                                -Once in 2weeks

kk

llnINVESTIGATIONS:

SAMPLE AND TESTS

BEFORE TREATMENT

AFTER TREATMENT

|BLOOD –

CBC, ESR, CRP (quantitative LAB)

       |LFT, RFT, HbA1C, URINE –

Routine and Microscopy For Screening Purpose

|FBS, PPBS, TFT

 k

ASSESMENT CRITERIA (SCORING PATTERN)64

The assessment of the effect of treatment will be recorded before and after intervention. The clinical features will be graded on the basis of scoring system to be adopted as below

1.    Shoulder Pain and Disability Index (SPADI) (Annexure I)

2.     Pain - Visual Analogue Scale (VAS) (Annexure II)

Sl. No

Pain

Grade

|1.

VAS range in between 0 – 2

0

|2.

VAS range in between 2– 4

1

|3.

VAS range in between 4 – 6

2

|4.

VAS range in between 6 – 8

3

|5.

VAS range in between 8 – 10

4

3.     3. The shoulder movement will be assessed (Goniometry) on the basis of indices as below- A goniometer is used to measure the angle of a joint’s movement in degrees-

kkFlexion -

S.No.

Flexion

Grade

|1.

161°- 180°

0

|2.

121°- 160°

1

|3.

81°-120°

2

|4.

41°- 80°

3

|5.

0°- 40°

4

Extension –

S.No.

Extension

Grade

|1.

41°- 60°

0

|2.

31°- 40°

1

|3.

21°- 30°

2

|4.

11°- 20°

3

|5.

0°- 10°

4

Internal Rotation -

S.No.

Internal Rotation

Grade

|1.

81°- 90°

0

|2.

61°- 80°

1

|3.

41°- 60°

2

|4.

21°- 40°

3

|5.

0° - 20°

4

External Rotation –

S.No.

External Rotation

Grade

|1.

81°- 90°

0

|2.

61°- 80°

1

|3.

41°- 60°

2

|4.

21°- 40°

3

|5.

0°- 20°

4

Abduction –

S.No.

Abduction

Grade

|1.

161°- 180°

0

|2.

121°- 160°

1

|3.

81°- 120°

2

|4.

41°- 80°

3

|5.

0°- 40°

4.

Adduction -

S.No.

Adduction

Grade

|1.

61°- 70°

0

|2.

51°- 60°

1

|3.

41°- 50°

2

|4.

21°- 40°

3

|5.

0°- 20°

4.

PRIMARY END POINTS:

• Improvement in Range of Motion (ROM) of shoulder joint and pain intensity as measured by VAS from Pre-treatment to Post-treatment.

SECONDARY END POINTS:

• Time to significant pain relief or functional improvement.