EFFICACY OF MUNZIJ WA MUSHIL-E-

BALGHAM, MAJOON-E-HINDI AND DALK WITH ROGHAN-E-LAQWA IN

FUNCTIONAL INDEPENDENCE

RECOVERY OF POST STROKE PATIENTS

Submitted by

Mohd ShahidP.G. Student, Dept. of Moalajat,

Under Supervision ofProf. M.A.SIDDIQUENational Institute of Unani Medicine

NEED FOR THE STUDY 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.

CONT......... 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.

CONT...... 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.

CONT....... 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.

REVIEW OF LITERATURE 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) .

CONT.... 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.

CONT..... 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.

OBJECTIVES OF THE STUDY

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

MATERIAL AND METHODS 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.

CRITERIA 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

CONT..... 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

PARAMETERS Objective parameters:

Functional Independence Measure Timed Up and Go test

FUNCTIONAL INDEPENDENCE MEASURE Self-care Eating Grooming Bathing/showering Dressing upper body Dressing lower body Toileting Sphincters Bladder

management Bowel management

Mobility Transfers:

bed/chair/wheelchair

Transfers: toilet Transfers:

bathtub/shower Locomotion:

walking/wheelchair Locomotion: stairs

CONT..... Communication Expression Comprehension

Psychosocial Social interaction

Cognition Problem solving Memory

SEVEN LEVELS FOR EACH ITEM 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)

CONT........ 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

TIMED UP AND GO TEST 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.

TRIAL FORMULATION:

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

CONT....... 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

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.

CONT...... 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

CONT..... 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

PROCEDURE OF STUDY: 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.

CONT.... 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.

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

INFORMED CONSENT FORM 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.

CONT..... 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.

PATIENT CONSENT FORM 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:

Always welcome at drshahidkhan2005@gmail.com

Thanks for your patience