Clinical Evaluation of Hijamat Bil Shurt (Wet Cupping) and Majoon Ushba with local application of UNIM 304 in the Management of persistent non specific Wajaul Zahar (Low Back Pain)

STUDY SUBJECTIVES

·         To evaluate the efficacy of Hijamat Bil Shurt (Wet Cupping) and Majoon Ushba with local application of NIUM 304 in the management of Wajaul Zahar (Low Back Pain).

·         To evaluate the safety of Hijamat Bil Shurt (Wet Cupping) and Majoon Ushba with local application of NIUM 304 in the management of Wajaul Zahar (Low Back Pain).

SELECTION CRITERIA

Inclusion Criteria

·         Patient in age group of 18 to 60 years

·         Either sex male/ female

·         Non specific low back pain persisting for more than 4 weeks.

Exclusion Criteria

·         Patient below the age of 18 and above the age of 60 years.

·         Anemia (Hb% <10gms)

·         Diabetes Mellitus

·         Patients having past history of bleeding disorders.

·         Liver diseases

·         Renal failure

·         Hypothyroidism

·         Ischemic Heart Diseases

·         Pregnancy and lactating women

·         Who not agreed to sign the informed consent

SAMPLE SIZE

The sample size will be fixed as 80 patients.

DURATION OF PROTOCOL THERAPY

The total duration of protocol therapy will be 28 days.

DURATION OF THE STUDY

The required number of trail subjects will be attainable in the institute’s OPD in two years. Hence the duration of research project will be two years.

STUDY SITE

The study will be conducted at the Regional Research Institute of Unani Medicine (RRIUM) Patna.

TREATMENT DETAILS

Wet cupping setting:

Days

0

14

|Sitting

1st

2nd

 Basic cupping therapy equipment is used including a hand suction pump, plastic cup of the same size and the antiseptic solution. Each wet cupping treatment procedure take about 20 minutes and conducted in 5phage:

Primary suckling: The cup is placed on selected site and the cup clings to the skin and it is left for a period of 3-5 minutes.

Scarification: Superficial incision made on the skin using 11 no. surgical blades.

Bloodletting: The cup is placed on the selected site where superficial incision made, until it is filled with blood from the capillary vessels.

Removal: The cup is removed.

Dressing: Dressing with the antiseptic solution on incision site.

 The following Unani Pharmacopoeial formulation will be used in this study:

StudyDrug

 Dosage

Form

 Dose

 Frequency

 Route of

Administration

 Method of administration

  |MajoonUshba

Semi solid

7gm

Twice daily

Oral

To be taken with water after meals

| UNIM 304

 Liquid

 S.Q

 Twice daily

 Local application

 Local application

Composition of Test Drug- Majoon Ushba (NFUM, Part-I, p. 145)

S.N.

Ingredients

Quantity

|1

Sana

80gm

|2

Sandal Surkh

60gm

|3

Sandal Safaid

60gm

|4

Chobchini

60gm

|5

Gul e Surkh

60gm

|6

Darchini

40gm

|7

Kababchini

40gm

|8

Gaozaban

40gm

|9

Aftimoon

40gm

|10

Bisfayej

40gm

|11

Ushba

40gm

|12

Post e Balela

20gm

|13

Sambulul Teeb

20gm

|14

Halela Siyah

15gm

|15

Post e Halela Zard

10gm

|16

Asal / Qand Safaid

2kg

CONCOMITANT/ ADJUVENT THERAPY

No concomitant medication allowed.

FOLLOW UP EVALUATION

Clinical follow up

The patients will be assessed clinically at base line and at the end of the study. Hijamat bil shurt done upto 2 settings i.e. base line and 14th day only, Majoon Ushba (7gm twice a day) & UNIM 304 (Local application) will be given 28 days on every 14 days fallow up. Subjective and objective clinical observations will be recorded in the follow up sheet.

Re-Scheduling Follow-Up Visits

If any follow-up visit is missed, the visit will be rescheduled as soon as possible within an

interval of +/ – 5 days.

Laboratory Follow up

The pathological, biological and radiological investigations will be conducted at baseline and at the end of the study. The laboratory findings will be recorded in the follow up sheet.

ASSESSMENT OF MIZAJ (TEMPERAMENT)

In each selected patients mizaj was assessed based on the Ajnase Ashra (10 different parameters) mentioned in Unani literature will be done at baseline and at the end of study. (Annexure-V)

LABORATORY INVESTIGATIONS

Each case of Wajaul Zahar selected for the study will be subjected to the following pathological, biochemical, urological and radiological investigations at baseline and at end of the study, except ECG, CT, BT and RBS. It will be on base lineonly.

Pathological investigations:

·         Complete Blood Picture (Hb%, TLC, DLC, ESR)

·         CT

·         BT

·         RBS

·         LFT (Serum Bilirubin, SGOT, SGPT)

·         RFT (Serum Creatinine, Blood Urea, Uric Acid)

·         X-ray (LS Spine)

·         ECG

ASSESSMENT OF EFFICACY

Subjective parameters:

·         Low back pain

·         Tenderness in the lower back

·         Difficulty in the movement due to low back pain

Objective parameters:

These are analyzed with the help of Visual Analogue Scale (VAS)

Grades of Pain:

Grade

Nature of pain

Characteristic of pain

Score

|0

No=0

No pain

  |1-3

Mild=1

Pain after walking a distance of 200 meter.

|4-6

Moderate=2

Pain after walking a distance of 100 meter.

|7-10

Severe=3

Pain at household activities.

Grades of Tenderness:

Grade

Nature of pain

Characteristic of tenderness

Score

|0

No=0

No tenderness

  |1-3

Mild=1

Barely perceptible (patient says it is tender).

|4-6

Moderate=2

Patient says it is tender, winces and pulls back.

|7-10

Severe=3

Patient does not allow to palpation.

Grades of Difficulty on Movements:

Grade

Nature of pain

Characteristic of movement

Score

|0

No=0

No difficulty on movements.

  |1-3

Mild=1

Difficulty after movement a short distance

|4-6

Moderate=2

Difficulty after movement a long distance

|7-10

Severe=3

Unable to movement