EFFICACY OF MUNZIJ WA MUSHIL-E-BALGHAM (POLY HERBAL FORMULATIONS) AND MASSAGE WITH ROGHAN-E-MALKANGANI IN FALIJ NISFI (HEMIPLEGIA): A RANDOMISED CONTROLLED CLINICAL TRIAL

EFFICACY OF MUNZIJ WA MUSHIL-E-BALGHAM (POLY HERBAL FORMULATIONS) AND MASSAGE WITH ROGHAN-E-MALKANGANI IN FALIJ NISFI (HEMIPLEGIA): A RANDOMISED CONTROLLED CLINICAL TRIAL

Abdal Ahmed ¹, Abdul Nasir Ansari ², S. Javed Ali ^*3 and Mohd Yasir ⁴

Department of Moalajat¹, Iram Unani Medical College, Lucknow, U.P., India

Department of Ilaj Bit Tadabeer ², Research Scholar, Department of Medicine ^{3, 4} National Institute of Unani Medicine, Bangalore, Karnataka, India

ABSTRACT: This study was conducted as a single blind, randomized and standard controlled clinical trial in cases of Falij Nisfi (Hemiplegia) due to ischaemic stroke. Forty eligible patients of Hemiplegia were randomized into test and control groups, comprising 20 patients in each.  Test group was given Nuskha munzije balghamfor12 days, followed byNuskha Mushile Balgham, mixed with Munzije Balgham for next two consecutive days in decoction form, orally. Massage was started from 15^th day with Roghan Malkangani on spinal column and paralyzed limbs for 15 minutes daily till 28^th day. Control group was given tablet Piracetam Hydrochloride, 800 mg twice a day. Hypertensive patients in both groups, A and B, also received tablet Aspirin, 75 mg and tablet lisinopril, 2.5 mg, once daily for 28 days. The assessment of efficacy was based on “Stroke Rehabilitation Assessment of Movement (STREAM)”. Pre and post treatment values of STREAM were subjected to statistical analysis within and between the groups using Paired‘t’ test, Wilcoxon matched pairs signed rank test, and  Kruskal-Wallis test with Dunn’s multiple comparison test. There was significant improvement in STREAM scores for voluntary movements of upper limb (P<0.01), lower limb (P<0.01), Basic mobility (P<0.01), and total score (P<0.01), in test Group as compared to control Group. The study revealed that test drug has statistically significant response in improving voluntary movements as compared to control drug.

Falij, Nuskha Munzije Balgham, Nuskha Mushile Balgham, Roghan Malkangani

INTRODUCTION: Stroke is the second leading cause of mortality worldwide and third most common cause of death in the developed world.¹ Ischemic stroke accounts for more than 80% of all strokes.² it usually results from predisposing conditions that originated years before the ictus.³  Up to 90% of stroke survivors report one or more disabilities including decreased motor control and movement.⁴

Modern treatment is aimed at minimizing the volume of the brain that is irreversibly damaged, preventing complications, reducing disability and handicap through rehabilitation, and reducing the risk of recurrent episodes.¹ In Unani medicine, Falij has been described elaborately in relation to its predisposing factors, causes and treatment in almost all standard text books of Unani medicine. Unani Physicians, Buqrat, Jalinoos, Ibne Sina, Razi and all successors are known to have treated the Falij Nisfi on the principles of Tanqia and Tadeel since centuries.

The combination of Tanqia and Tadeel makes comprehensive treatment line for Falij and mandates to be tested as such to assess the efficacy of employable intervention in its treatment scientifically.

Methodology

The present study was conducted at National Institute of Unani Medicine (NIUM)Hospital. A comprehensive protocol was framed and approval obtained from the Ethical Committee of National Institute of Unani Medicine. After obtaining written voluntary consent from eligible patients, clinical study was started by enrolling them into test and control groups by random allocation, achieved by lottery method. This study spanned from February 2011 to March 2012.

 Criteria for Selection of Cases:

Inclusion Criteria:

a) Hemiplegia secondary to ischaemic stroke, b) Stroke onset between 4 weeks to 5 years c) Stroke confirmed as ischaemic radiologically, d) Either gender, between 18-70 years of age, e) No significant pre- stroke disability

 Exclusion Criteria:

a) Minor stroke with non-disabling deficit, b) Patients with altered sensorium or aphasia serious enough to impair Understanding of simple commands, d) Pregnancy and lactation, e) Advanced uncontrolled systemic illnesses, f) Co-existent major neurological and psychiatric diseases, g) History of seizures, h) Patients who fail to follow up, i) Patients who fail to give consent, j) Conditions, where massage is contraindicated

 Investigations: following investigations were done primarily for two purposes- a) To      exclude other patients as a part of exclusion criteria; b) To establish the safety of the test drug - Hb%, TLC, DLC, ESR, Blood Sugar-F/PP, Serum Cholesterol, KFT, LFT, X-Ray Chest PA View and ECG

Test drug:

The ingredients of Munzij Balgham: ⁶

Badyan (Foeniculum vulgare, Bekh Badyan (Foeniculum vulgare root), Maveez Munaqqa  (Vitis vinifera), Ustukhuddoos (Lavendula stoechas), Inabussalab (Solanum nigrum), Bekh Kibr (Capparis spiosa), Persiaoshan (Adiantum capillus veneris) 5 gm each.

 The ingredients of Gulqand:

Gul-e-surkh (Rosa damascene Mill)and Shakar safaid (Sugar) 25 gm each.

The ingredients of Mushil Balgham:⁶

Ustukhuddoos (Lavendula stoechas) 5gm, Barg Sana (Cassia angustifolia) 10gm, Turbud    (Ipomoea turpethum) 3gm, Maghz faloos (Cassia fistula) 50 gms, Roghan Zard (Ghee) 5gm

 The ingredients of Roghan Malkangani: ⁷

Malkangani(Celastruspaniculatus)……Q. S.

 Control drug:

Piracetam, 800 mg, Lisinopril, 2.5 mg, Aspirin 5 mg given orally in tablet form once daily in both groups for the control of hypertension.

 Procedure of study:

The study was designed as single blind, randomized, standard controlled clinical trial. A total of 40 patients were randomly allocated into two groups, comprising 20 patients in each of test (Group A) and control (Group B) group, respectively. The treatment period in both, Test and Control groups was ascertained as 28 days.

The ingredients of Munzij Balgham ⁶ were pounded and soaked in 250 ml. of water for whole night. Joshanda (decoction) was prepared in the morning on low heat as per the standard procedure. After filtration of Joshanda, 25 gm of Gulqand was mixed in filtrate and given to drink once in the morning before breakfast for 12 days. On 13^th day, the ingredients of Mushile Balgham were added in the ingredient of Munzije Balgham; Joshanda was prepared and given to drink in the morning before breakfast for two consecutive days.

On 15^th day, Dalk Layyan (massage) was started using 20 ml of warm Roghan Malkangani on the spinal column and affected limb for 15 minutes, once a day, for a period of 2 weeks i.e. up to 28^th day of the trial treatment. Along with the test drugs, the hypertensive patients were given Lisinopril, 2.5 mg, orally in the tablet form for the management of Hypertension while Aspirin, 75 mg, was given once in a day after meal to avoid the recurrence of ischemia for a whole period of 28 days. The control group receivedPiracetam, 800 mg, twice a day; Lisinopril, 2.5 mg, once a day; Aspirin 5 mg, once aday in tablet form, orally for a period of 28 days.

The assessment of efficacy of treatment in test and control group was carried out on the basis of a reliable and valid scale “Stroke Rehabilitation Assessment of Movement” (STREAM), especially designed for evaluation of motor functions. Assessment was carried out on zero day and 28^th day.

After 28 days of the treatment, Pre and post treatment values of STREAM were subjected to statistical analysis within and between the groups using Paired‘t’ test, Wilcoxon matched pairs signed rank test, and Kruskal-Wallis test with Dunn’s multiple comparison test. The effects of test and control drugs on voluntary motor control are discussed in following tables. (Table 1- 4).

TABLE 1: THE FOLLOWING TABLE DEPICTS EFFECT OF TEST AND CONTROL DRUGS ON UPPER LIMB SCORES. THE SCORES ARE SHOWN IN MEAN ± SEM

TABLE 2: THE FOLLOWING TABLE DEPICTS EFFECT OF TEST AND CONTROL DRUGS ON LOWER LIMB SCORES. THE SCORES ARE SHOWN IN MEAN ± SEM

TABLE 3: THE FOLLOWING TABLE DEPICTS EFFECT OF TEST AND CONTROL DRUGS ON BASIC MOBILITY SCORES. THE SCORES ARE SHOWN IN MEAN ± SEM 

TABLE 4: THE FOLLOWING TABLE DEPICTS EFFECT OF TEST AND CONTROL DRUGS ON TOTAL SCORES. THE SCORES ARE SHOWN IN MEAN ± SEM

DISCUSSION AND CONCLUSION: According to the tenets of Unani medicine, health is reflection of equilibrium in four Akhlat (humours) with respect to their quantity and quality, conferring Mizaj Tabai to the human body, necessary for occurrence of normal functions. Any disturbance in the equilibrium of these four Akhlat leads to Sue Mizaj (ill temperament), responsible for abnormal bodily functions and a reflection of disease. Sue Mizaj Maddi (abnormal temperament)means a derangement in Mizaj tabai (normal temperament) coupled with abnormality in Madda (material). Correction of Sue Mizaj Maddi requires elimination of abnormal Madda for restoration of Mizaj Tabai.^{8, 9}

Since, Falij is caused due to Ghair Tabai Balgham (abnormal phlegm); it produces Sue Mizaj Maddi in the body and needs Madda to be eliminated to restore Mizaj Tabai. The elimination of abnormal humour/Madda is known as Tanqia (evacuation/elimination) and restoration of Mizaj Tabai is known as Ta’deel (normalization).¹⁰

 Tanqia is the first step in the treatment of Falij and is performed by employing Munzij (coctives) and Mushile Balgham drugs (phlegm purgatives) and Ta’deel is the second step which requires employment of various compound drug preparations along with a gamut of regimenal procedures e.g.  Dalak, Hijamat, Hammam etc. to restore and potentiate the functions of the involved organs. ^{5, 10, 11}

 Tahleel (dissolution), Taqtee and Talteef are the properties of Munzij Balgham drugs which make the fulcrum of the first phase of Tanqia and fairly resemble with the principles of treatment of stroke in modern medicine advocating use of Thrombolytics, Antithrombotic agents and Neuroprotective drugs. ¹²

The drugs having power of Tahleel are known as Muhallil and may be defined as the drugs which act on a Ghaleez Khilt (viscid humour) to make it dissoluble and detachable from its site of attachment.¹⁰ Dawae Lateef is inherent with the property of Talteef and interacts with body’s Quwwat Tabiya to divide the morbid matter into smaller parts.¹⁰ Muqatti advia are those drugs, which owing to property of Taqtee, penetrate into the interstitial spaces of the organs due to their lightness and remove the adhered khilt from the organ.¹⁰

It is vital to dissolve and disintegrate the Balghami Sudda first, and purgate it out later from the body. The first part, in this study, was achieved by using Nuskha Munzij Balgham for twelve days. All the drugs of Munzije Balgham, especially, Ustukhuddoos, Persiaoshan, Mako Khushk, Bekh kibr, Badyan and Maveez Munaqqa possess the properties such as Muhallil, Mulattif, Mufatteh Sudad, Munaqqie Dimagh, Muqawwie Asab, Qate Balgham, Munaqqie Akhlate Ghaleeza, Jali etc. and are; therefore, used in diseases such as Falij (hemiplegia), Isterkha (paresis), Rasha (tremors), Zofe Asab (weakness of nerves), Sara (epilepsy), Laqwa (facial palsy), Suda (headache)and other Balghami Amraz etc. ^{13, 14, 15, 16, 17, 18, 19, 20, 21}

Once the Balghami madda (Phlegmatic material) is dissolved, detached and disintegrated by the action of Munzije Balgham (phlegm coctives) drugs, it is purgated out by Mushlie Balgham (phlegm purgatives) drugs. Mushil drugs have property to expel the Akhlat raddiya (Morbid humours) from the vessels, neighboring structures and from whole body through intestine.

Majority of the Unani physicians opine about the action of Mushil drugs that they expel both Raqeeq (thin) and Ghaleez (viscid) constituents of Akhlat, ^{10, 22} which they have affinity with. The ingredients of Nuskha Mushile Balgham have affinity with Balgham and, therefore, purgate it out. The Nuskha Mushile Balgham contains the following drugs: Turbud, Barg sana, Khayar shambar, Roghan Zard, Ustukhuddoos.

These drugs are endowed with the properties such as Mushile Akhlate Salasa, Mushile Balgham, Munaqqie Diamgh, Mukhrije Balgham, Qate Balgham, Mulattif, Jali and Mufattehe Sudad etc. and, thus, are frequently used in diseases such as Amraze Asab e.g. Falij, Laqwa and Rasha. ^{17, 16, 18, 19, 20, 23}  After purgation of Ghaleez Ghair Tabai Balgham, which produces Sudda (obstruction) to cause Falij, the nervous structures become receptive to regain lost vigor, vitality and normal functions. This phase of recuperation and rejuvenation is known as Ta’deel (Normalization) and is accomplished by using various regimenal procedures such as massage, cupping, exercises etc. ^{9, 10, 22}

 Ta’deel generally means normalization, restoration and potentiation of physiological functions of an organ and is achieved by restoring the Mizaj moatadil. After a course of Mushil, The remnant Baroodat (coldness), diffused in Asab, is removed by massaging oils having Har advia (hot natured drugs). Roghan Malkangani was used for this purpose. Malkangani has properties such as Dafae Amraze Barida wa Balghamia, Muqavvie Asab (neurotonic), Muqavvie Dimagh wa Hafiza (brain tonic and memory enhancer) etc. and, therefore, is used in diseases such as Falij, Laqwa, Rasha etc. ^{15, 18, 24}

 Tadeel is the last phase of treatment of Falij (paralysis) and is used for a variable period of time depending upon the severity of the disease and loss of functions.²² Massage with Roghan Malkangani was done for 14 days in test group to regain the motor power in the limbs.

Test group showed statistically significant improvement in motor recovery in all parameters in comparison to the control group and may be due to institution of a complete regimen of therapy based on principles of Unani medicine.

 Motor recovery in stroke and possible role of test formulation:

There are a number of processes that may contribute to the recovery of motor function after stroke:

¨      Resolution of pathological changes allowing for recovery at the cellular level.

¨      Development of compensatory movement strategies enabling ‘recovery’ of certain motor functions.

 ¨      Taking over the function of damaged or disconnected area by undamaged regions in the sensory-motor make over.²⁵

 Resolution of Pathology and hypothetical role of test drug:

In acute stages after stroke, recanalisation of occluded vessels, establishment of collateral flow and reduction in inflammation, all contribute to salvaging partially spared tissue. Potentially resolvable pathological results of stroke are particularly relevant to the ischemic penumbra. Limiting neuronal damage in the surrounding penumbra is a major goal for acute therapeutic interventions as neurons they are initially structurally intact.²⁶

The above mentioned pathological changes in and around the infracted zone provide a premise for the possible mechanism of action of the ingredients of test formulation. As described earlier, test formulations possess Muhallil, Mulattif, Munaqqie Dimagh, Mufatteh Sudad, Muhallile Auram and Jali properties which, by the definition of Unani medicine, ^{13, 16, 18, 19, 20, 21, 27} tend to open the obstruction and recanalise the vessels; reduce the inflammatory reaction and edema; scale down the damage of ischemic penumbra, and ultimately limiting the neuronal damage by cumulative action of ingredients of test formulation. The presenting rational correlation between the developed pathology in stroke and counteracting properties of the test drugs seem to have a significant effect in improving the motor power in the hemiplegic patients.

 Enhancement in brain plasticity

In recent years, it has become increasingly evident that representational networks in the adult brain are capable of extensive reorganization after damage of a specific area of the brain. Recovery of motor functions after stroke is also associated with changes in motor cortical representation.²⁸

 It is thought that undamaged areas and pathways in the brain ‘take over’ the functions of the damaged regions. The plasticity of brain seems to have been enhanced by the Muqavvie Dimagh (brain tonics) and Munaqqie Asab (nerve cleanser) ^{13, 14, 15, 18}properties of the ingredients of the test formulations. These drugs, owing to their properties, seem to be capable of up regulating the function of the undamaged area to help them take over the function of the damaged areas easily.

Sprouting of new connections:

Local growth of axons and synapses could provide a mechanism for intracortical remapping of sensory motor representation. Sprouting can also occur remotely from the site of damage as well as around the lesion rim. Increased expression of synaptophysic has been detected in the contralesional hemisphere 14 to 16 days after experimental stroke ²⁵ and dendritic sprouting has been found in pyramidal cells in the intact hemisphere after cortical lesion in rats.²⁵ Muqavvie Dimagh, Munaqqie Dimagh, Muqavvie Asab properties of the test formulations might have a significant role in stimulation of sprouting of new connection in and around the damaged area to restore the lost functions.

Thus, it may be concluded from the above discussion that the test drugs formulations used in Tanqia and Tadeel have all the potential properties which seem to have positive effects not only in controlling the pathological changes but reverting them to normal state to restore the motor functions.

ACKNOWLEDGEMENTS: The authors are thankful to Director, NIUM, Bangalore and hospital staff for providing necessary facilities needed for research work.

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    How to cite this article:

    Ahmed A Ansari AN Ali SJand Mohd Y: Efficacy of Munzij Wa Mushil-E-Balgham (Poly Herbal Formulations) And Massage With Roghan-E-Malkangani In Falij Nisfi (Hemiplegia): A Randomised Controlled Clinical Trial. Int J Pharm Sci Res2015; 6(1): 453-58.doi: 10.13040/IJPSR.0975-8232.6 (1).453-58.

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