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
|
|