Yesterday, I have present it in front of Ethical commettee.

1. Submitted by
Mohd Shahid
P.G. Student, Dept. of
Moalajat,
Under Supervision of
Prof. M.A.SIDDIQUE
National Institute of Unani
Medicine

2.  Stroke is defined as “Sudden onset of
neurological deficit from vascular
mechanism”.
 According to WHO, stroke is one of the
leading causes of death and disability
throughout the world.
 Coronary heart disease and
Cerebrovascular diseases particularly
Stroke are responsible for between 40 and
50 percents of all deaths.

3.  According to WHO, both in developed and
developing countries, nearly one-third of
stroke patients died within 3 weeks and
48% died within one year.
 The incidence of cerebrovascular diseases
increases with age, and the number of
strokes projected to increase as elderly
population grows.

4.  In Unani medicine, Falij has been
described elaborately in relation to its
predisposing factors, causes and
treatment in almost all standard text
books.
 Falij has been treated successfully by the
Unani physicians based on the principles
of Tanqia and Tadeel which translates into
use of Munzij wa Mushil-e-Balgham drugs
followed by employment of massage with
an oil and administration of Haar Majoon.

5.  The amalgamation of these seemingly
different modalities makes a unit of
comprehensive treatment of Falij and
mandates to be tested as such to assess
the efficacy of employable intervention in
its treatment scientifically.
 Keeping in view, this clinical study will be
undertaken to assess the efficacy of Unani
regimen on gait performance, social
participation and quality of life.

6.  The WHO defined stroke as “Rapidly
developed clinical signs of focal (or
global) disturbances of cerebral function,
with symptoms lasting more than 24
hours or longer, leading to death, with no
apparent cause other than of vascular
origin. The 24 hours threshold in the
definition excludes transient ischemic
attack (TIA) .

7.  Recovery after stroke is influenced by both intrinsic
and extrinsic factors. Spontaneous recovery probably
represents the return to function of undamaged parts
of the brain through resolution of local factors like
edema and the absorption of necrotic tissue debris
and opening of collateral channels for circulation to
the lesion area. This development is rather short in
time, 3-4 weeks, and further recovery is explained by
other mechanisms which underlie what is called brain
plasticity, that is reorganization of neural
mechanisms. Brain plasticity includes unmasking of
pathways previously functionally inactive, sprouting
of fibers from surviving nerve cells with formation of
new synapses and redundancy in neural circuitry, i.e.
multiple parallel pathways sub serving similar
function. This plasticity is thought to be driven by
experiences, mobility, activity, interventions and the
physical features of environment and its demands.

8.  Falij is the paralysis of one half of the body
longitudinally with loss of sensory and motor
functions of affected side. Paralysis involving
face, limb and trunk is called Falij ma Laqwa
(complete stroke). The extent of paralysis differs
according to the underlying cause, site of the
brain affected, and type of the Khilt (humour)
involved. It occurs due to the occlusion in the
pathway of Rooh Haiwani which obstruct the
pathway of Rooh Hissi.
 It is believed that this condition develops due to
accumulation of Ghaleez Balgham or Dam in
Batoon-e-Dimagh . Munzij and Mushil drugs are
used to suitably modify the consistency of
Ghaleez Balgham in order to easily evacuate it
through stool.
 After Munzij and Mushil, Muqawwiyaat are given
to strengthen the diseased organ.

9.  ToEvaluate the Efficacy of Munzij wa Mushil
e-Balgham, Majoon e-Hindi and Dalk with
Roghan e-Laqwa in Functional Independence
Recovery of Post Stroke patients

10.  Source of Data: Moalajat OPD/IPD of NIUM,
Bangalore
 Study design: Open Clinical Trial
 Sample size: 30 Patients
 Duration of protocol: 30 days.
 Follow ups: 12th, 14th and 30th day
 Duration of Study: One and Half year.

11.  Inclusion criteria:
 Hemiplegia secondary to stroke
 After 1 months to 5 years of stroke onset
 Stroke clinically or radiologically diagnosed
 Both gender
 Age between 18-65 years
 Exclusion criteria:
 Age below 18 or above 65 years
 Minor stroke with non-disabling deficit

12.  No significant pre-stroke disability
 Patients with altered sensorium, aphasia,
serious enough to impair understanding of
simple commands
 Pregnancy and lactation
 Advanced liver, kidney, cardiac, pulmonary
diseases
 Orthopedic or Rheumatological diseases
impairing mobility
 Poor controlled Diabetes mellitus
 History of Seizures
 Patients, who fail to give consent
 Conditions, where massage is contraindicated

13.  Objective parameters:
 FunctionalIndependence Measure
 Timed Up and Go test

14.  Self-care  Mobility
 Eating  Transfers:
 Grooming bed/chair/wheelchair
 Bathing/showering  Transfers: toilet
 Dressing upper body  Transfers:
 Dressing lower body
bathtub/shower
 Locomotion:
 Toileting
walking/wheelchair
 Sphincters
 Locomotion: stairs
 Bladder
management
 Bowel management

15.  Communication
 Expression
 Comprehension
 Psychosocial
 Social interaction
 Cognition
 Problem solving
 Memory

16.  Level Description
7 Complete independence Fully independent
6 Modified independence Requiring the use
of a device but no physical help
5 Supervision Requiring only standby
assistance or verbal prompting or help with
set-up
4 Minimal assistance Requiring incidental
hands-on help only (subject performs > 75%
of the task)

17. 3 Moderate assistance Subject still performs
50–75% of the task
2 Maximal assistance Subject provides less
than half of the effort (25–49%)
1 Total assistance Subject contributes < 25%
of the effort or is unable to do the task

18.  The patient sits in the chair with his/her back
against the chair back.
 On the command “go”, the patient rises from
the chair, walks 3 meters at a comfortable and
safe pace, turns, walks back to the chair and sits
down.
 Timing begins at the instruction “go” and stops
when the patient is seated.
 Scores range from 1 to 5 based on the observer's
perception of the patient’s risk of falling.
 The patient should have one practice trial that is
not included in the score (Podsiadlo &
Richardson 1991).
 Patient must use the same assistive device each
time he/she is tested to be able to compare
scores.

19.  Ingredients of Munzij-e- Balgham:
 Badiyan Foeniculum vulgare Mill.
5 grams/day
 Maweez (Munaqqa) Vitis vinifera Linn.
5 grams/day
 Ustukhuddus Lavandula stoechas Linn.
5 grams/day
 Inabussalab Solanum nigrum Linn.
5 grams/day
 Bekh Kibr Capparis spinosa
5 grams/day
 Parsiaoshan Adiantum capillus-veneris
Linn.
5 grams/day

20.  Ingredients of Mushil-e- Balgham :
 Ustukhuddus Lavandula stoechas Linn.
05 grams/day
 Barg Sana Cassia angustiafolia
10 grams/day
 Turbud Operculina turpethum
03 grams/day
 Maghz faloos Cassia fistula
07 grams/day
 Roghan Zard Ghee
05 grams/day

21.  The ingredients of Majoon-e-Hindi
 Mirch siyah Piper nigrum
 Peepal Piper chaba Linn.
 Bach (Waj) Acorus calamus
 Taj (Saleekha) Cinnamomum cassia
 Baobarang Embelia ribes
 Sheetraj Plumbago zeylancia
Linn.
 Ustukhuddus Lavandula stoechas
Linn.
 Badiyan Foeniculum vulgare Mill
 Mulethi (Asl-us-Soos) Glycyrrhiza glabra
Linn.
 Maweez (Munaqqa) Vitis vinifera Linn.

22.  All the drugs in equal quantity and honey two
times of cumulative weight of rest of the
drugs will be taken and Majoon prepared as
per the standard procedure.
Ingredients of Gulqand:
 Gul-e-surkh Rosa damascene Mill.
25 grams
 Shakar safaid White sugar
25 grams

23.  The ingredients of Roghan-e-Laqwa
 Irsa (Sosan) Iris ensata Thunb.
10.50 grams
 Seer (Lahsan) Allium sativum Linn.
10.50 grams
 Roghan kunjud Sesamum indicum Linn.
40 ml

24.  Diagnosed patients of stroke, qualifying
the inclusion criteria, will be enrolled in
the treatment group, after having their
informed consent. Before starting the
treatment, the degree of functional
disability will be ascertained using
Functional Independence Measure (FIM)
and Time up and go test.

25.  Patients shall be given decoction of Munzij-e-
Balgham orally along with Gulqand in the
prescribed doses once a day in the morning
before breakfast for 12 days. On 13th day,
ingredients of Munzij-e-Balgham will be mixed
with that of Mushil-e-Balgham and prepared
Decoction will be given only for one day in the
morning.
 On 14th day of the treatment, Majoon-e-Hindi
will be given 12 gms daily and Dalk (massage)
employed, using 20 ml of warm Roghan-e-Laqwa
on the spine and paralysed parts for 15 minutes
once a day up to 30th day.

26.  Hb%, TLC, DLC, ESR
 BLOOD SUGAR-F/PP
 Kidney Function Test (KFT)
 Liver Function Test (LFT)
 ECG

27.  Title of the study:
Therapeutic Efficacy of Munzij wa Mushil-e-Balgham, Majoon-e-
Hindi and Dalk with Roghan-e-Laqwa in Functional Independence
Recovery of Post Stroke patients
 Information to the participants:
The main aim of the present study is to evaluate the “Efficacy of
Munzij wa Mushil-e-Balgham, Majoon-e-Hindi and Dalk with
Roghan-e-Laqwa in Functional Independence Recovery of Post
Stroke patients” and to provide safe, effective and economic
treatment in the management of Falij. The total duration of
study is 30 days. There are no reasonably foreseeable risks or
discomforts to you during the research. The confidentiality of
records identifying you will be strictly maintained and only the
research scholar or the guide will have access to your medicals
records. All your blood and any sample will be utilized only for
research purpose. You may contact me for trial related queries,
and you have rights to clear all yours doubts regarding the
treatment or any possible adverse reactions of the treatment. No
anticipated prorated payment shall be made to you for
participating in the trial. You are responsible for all the
consequences of the treatment, either benefits or harm, on
participation in the trial. You have to answer the entire pertinent
question asked by the research scholar regarding your illness.

28.  Undertaking by the investigator:
Your consent to participate in the above
mentioned study by Mohd Shahid, P.G Scholar,
Dept. of Moalajat, NIUM, Bangalore is sought.
You have the right to refuse consent or withdraw
the same during any part of the study without
giving any reason. In such an event, you will
continue to receive the treatment as usual. If
you have any doubts about the study, please feel
free to clarify the same. Even during the study,
you are free to contact the investigator for
clarification if you desire. All the
information/data collected from you will be kept
in strict confidence.

29.  I............................s/d/o………….………………...exercising
my free power of choice, hereby give my consent to be
included as a subject in the clinical study “Efficacy of
Munzij wa Mushil-e-Balgham, Majoon-e-Hindi and Dalk
with Roghan-e-Laqwa in Functional Independence Recovery
of Post Stroke patients. I understand that, I may be
treated with these regimens for the disease, I am suffering
from………………………………………. I have been informed to my
satisfaction, by attending physician the purpose of the
clinical trial and the nature of the treatment and follow up
including the laboratory investigation to monitor and
safeguard my body function.
I am also aware of my right to opt out of the trial at any
time during the course of the trial without having to give
the reason for doing so.
 Signature of the patient:
 Signature of the attending Physician:

30. Always welcome at
drshahidkhan2005@gmail.com
Thanks for your patience