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.

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).

	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 administration period                           -1 week(7days)

·       Oral Medication Period                                  -4 weeks(28days)

·       Follow Up Period                                           -4 Weeks(28days)

·       Review Period                                                -Once in 2weeks 

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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

 

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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.