Presentation on Psoriasis which is a chronic remitting and relapsing scaly, inflammatory and common skin disorder which is being treated by Unani System of Medicine ( a recognised traditional system by WHO ) from a very long time*.
DOUBLE BLIND CONTROLLED CLINICAL STUDIES OF A UNANI HERBO-MINERAL CREAM IN PATIENTS OF PSORIASIS
1. 1
DOUBLE BLIND CONTROLLED CLINICALDOUBLE BLIND CONTROLLED CLINICAL
STUDIES OF A UNANI HERBO-MINERALSTUDIES OF A UNANI HERBO-MINERAL
CREAM IN PATIENTS OF PSORIASISCREAM IN PATIENTS OF PSORIASIS
Latif A. , Saleem A., Rahman S. Z. , & Tahseen M. *Latif A. , Saleem A., Rahman S. Z. , & Tahseen M. *
Department of Ilmul Advia, A. K. Tibbiya CollegeDepartment of Ilmul Advia, A. K. Tibbiya College
Aligarh Muslim University Aligarh. * Department ofAligarh Muslim University Aligarh. * Department of
Dermatology, J. N. Medical College, A. M. U. Aligarh.Dermatology, J. N. Medical College, A. M. U. Aligarh.
2. 2
INTRODUCTIONINTRODUCTION
Psoriasis is a chronic remitting and relapsing scaly, inflammatoryPsoriasis is a chronic remitting and relapsing scaly, inflammatory
and common skin disorder which is being treated by Unaniand common skin disorder which is being treated by Unani
System of Medicine ( a recognised traditional system by WHO )System of Medicine ( a recognised traditional system by WHO )
from a very long time*. Sources of Unani drugs for Psoriasis arefrom a very long time*. Sources of Unani drugs for Psoriasis are
herbs, animals & minerals.herbs, animals & minerals.
The present study, double - blind placebo controlled, is done byThe present study, double - blind placebo controlled, is done by
using herbo-mineral preparation as topical application in cases ofusing herbo-mineral preparation as topical application in cases of
Psoriasis.Psoriasis.
________________________________________________________________________________________________________________________
* Kitabul- Hashaish of Dioscarides ( 70th B. C.)* Kitabul- Hashaish of Dioscarides ( 70th B. C.)
* Jameal- Mufradat-al-advia wa alaghzia of Ibn Baitar. (1248 A. D. )* Jameal- Mufradat-al-advia wa alaghzia of Ibn Baitar. (1248 A. D. )
* Al-Qanoon-fial-tibb (Cannon of Medicine) of Avicenna (980 - 1037 A. D.)* Al-Qanoon-fial-tibb (Cannon of Medicine) of Avicenna (980 - 1037 A. D.)
* Al- Hawi of Mohammad b. Zakaria al-Razi (866- 925 A. D.)* Al- Hawi of Mohammad b. Zakaria al-Razi (866- 925 A. D.)
3. 3
Material & MethodsMaterial & Methods
Drugs:Drugs:
The formulation of Cream consists of the followingThe formulation of Cream consists of the following
ingredients:-ingredients:-
1- Calomel (Hgcl- RasKapoor)1- Calomel (Hgcl- RasKapoor) 5% w/w5% w/w
2- Camphor (2- Camphor (Cinnamomum camphoraCinnamomum camphora LinnLinn.. )) 5% w/w5% w/w
3- Litharge (Pbo- Murdarsang)3- Litharge (Pbo- Murdarsang) 12% w/w12% w/w
4-4- Psoralea corylifoliaPsoralea corylifolia Linn. oilLinn. oil 10% w/w10% w/w
5- Cream base5- Cream base SQSQ
4. 4
Material and Method (Contd.)Material and Method (Contd.)
STUDY PROTOCOLSTUDY PROTOCOL
((A) - Phsico-chemical studies: - Solubility, Smooth flow Test, pH, M. p., Absorption of Cream by filter paperA) - Phsico-chemical studies: - Solubility, Smooth flow Test, pH, M. p., Absorption of Cream by filter paper
method & Tared Blade method:method & Tared Blade method:
(B) PATCH TEST(B) PATCH TEST
(C) - Clinical Studies: - three groups of 25 patients of Psoriasis (Total numbers of Patients 75) of either sex and(C) - Clinical Studies: - three groups of 25 patients of Psoriasis (Total numbers of Patients 75) of either sex and
different age groups were made as follows:different age groups were made as follows:
(I) Test Drugs(I) Test Drugs
(Herbo-mineral cream)(Herbo-mineral cream)
(II) Standard Drug(II) Standard Drug
(Dithranol ointment)(Dithranol ointment)
(III) Placebo-(III) Placebo-
(Pet Jelly)(Pet Jelly)
(D) Mode of Administration of Cream: Topical Application of Cream followed by exposure to sunlight for 5(D) Mode of Administration of Cream: Topical Application of Cream followed by exposure to sunlight for 5
minutes in morning & eveningminutes in morning & evening
(E) Routine investigation and "Candle Grease" examination is made by scrapping of affected part of the skin.(E) Routine investigation and "Candle Grease" examination is made by scrapping of affected part of the skin.
(F) Evaluation of Cases after every 15 days up to 90 Days & Post treatment Followup is also done.(F) Evaluation of Cases after every 15 days up to 90 Days & Post treatment Followup is also done.
5. 5
Physico- Chemical Studies:Physico- Chemical Studies:
General CharacteristicsGeneral Characteristics
SolubilitySolubility pHpH M. P.M. P. Smooth FlowSmooth Flow
TestTest
ColourColour
(a) Soluble in(a) Soluble in
chloroformchloroform
& CCl4& CCl4
b) Partiallyb) Partially
Soluble inSoluble in
Hot WaterHot Water
c)InSolublec)InSoluble
in Alcohol,in Alcohol,
Water (Cold),Water (Cold),
Pet-ether &Pet-ether &
etherether
Range-Range-
6. 6- 6. 86. 6- 6. 8
(By Elico(By Elico
pH Meter)pH Meter)
IndicatedIndicated
slightlyslightly
acidicacidic
Range fromRange from
8383 00
C- 86C- 86 00
CC
By ReichertBy Reichert
ThermovarThermovar
InstrumentInstrument
Uniform &Uniform &
SmoothSmooth
DistributionDistribution
BlackishBlackish
BrownBrown
15. 15
TOTAL RESPONSE OF HM CREAM, DIATHRANOL & PET JELLYTOTAL RESPONSE OF HM CREAM, DIATHRANOL & PET JELLY
0
10
20
30
40
50
60
70
80
90
100
HM
CREAM
DITH.
OINT.
PET
JELLY
TOTAL RESPONSE
CURED
RELEIVED
PARTIALLY
RELIVED
NO RESPONSE
16. 16
A COMPARATIVE STATEMENT SHOWING SIDEA COMPARATIVE STATEMENT SHOWING SIDE
EFFECTS IN TEST & STANDARD GROUPSEFFECTS IN TEST & STANDARD GROUPS
GroupsGroups Irritation (%)Irritation (%) Redness (%)Redness (%) Hyperpigmentation (%)Hyperpigmentation (%) Blister (%)Blister (%)
TestTest MildMild ModerateModerate SevereSevere MildMild ModerateModerate SevereSevere Light BlackishLight Blackish Dark BlackishDark Blackish
66
(24.6 )(24.6 )
NilNil NilNil 22
(8)(8)
NilNil NilNil 1717
(68 )(68 )
NilNil NilNil
StandardStandard
NilNil 55
(20)(20)
NilNil NilNil NilNil 77
(28)(28)
NilNil 1010
(40)(40)
33
(12)(12)
17. 17
S.S.
NoNo
Period ofPeriod of
RelapseRelapse
afterafter
CuredCured
ChronicityChronicity AgeAge sexsex Site of RecurrenceSite of Recurrence No. of RelapseNo. of Relapse
11
22
33
44
55
66
77
3 Months3 Months
5 Months5 Months
3 Months3 Months
2 Months2 Months
4 Months4 Months
7 Months7 Months
9 Months9 Months
1-2 Yrs1-2 Yrs
2-5 Yrs2-5 Yrs
5-12 Yrs.5-12 Yrs.
12-24 Yrs.12-24 Yrs.
2-5 Yrs.2-5 Yrs.
5-12 Yrs.5-12 Yrs.
10-12 Yrs10-12 Yrs..
12 Yrs.12 Yrs.
31 Yrs.31 Yrs.
45 Yrs.45 Yrs.
47 Yrs.47 Yrs.
28 Yrs.28 Yrs.
35 Yrs.35 Yrs.
45 Yrs.45 Yrs.
MaleMale
MaleMale
FemaleFemale
FemaleFemale
MaleMale
FemaleFemale
MaleMale
Abd, legAbd, leg
Neck, ScalpNeck, Scalp
Neck, ScalpNeck, Scalp
BacksideBackside
ChestChest
Forearm & LegForearm & Leg
Scalp, Leg & ArmScalp, Leg & Arm
WholeWhole
Scalp OneScalp One
WholeWhole
WholeWhole
WholeWhole
WholeWhole
WholeWhole
RECURRANCE STATUS OF STANDARD GROUP (Dithranol Ointment)RECURRANCE STATUS OF STANDARD GROUP (Dithranol Ointment)
18. 18
RECURRANCE STATUS OF TEST GROUPRECURRANCE STATUS OF TEST GROUP
(Herbo-mineral Cream)(Herbo-mineral Cream)
S. NoS. No Period ofPeriod of
RelapseRelapse
after Curedafter Cured
ChronicityChronicity AgeAge sexsex Site of RecurrenceSite of Recurrence No. of RelapseNo. of Relapse
11
22
33
44
55
6 Months6 Months
8 Months8 Months
8 Months8 Months
11 Months11 Months
12 Months12 Months
1-2 Yrs1-2 Yrs
2-5 Yrs2-5 Yrs
5-12 Yrs.5-12 Yrs.
12-24 Yrs.12-24 Yrs.
10-12 Yrs.10-12 Yrs.
8 Yrs.8 Yrs.
35 Yrs.35 Yrs.
38 Yrs.38 Yrs.
45 Yrs.45 Yrs.
50 Yrs.50 Yrs.
FemaleFemale
MaleMale
MaleMale
FemaleFemale
MaleMale
ScalpScalp
LegLeg
ForearmForearm
LegLeg
LegLeg
WholeWhole
Scalp OneScalp One
WholeWhole
WholeWhole
WholeWhole
No. Cases 5 (20 %)No. Cases 5 (20 %)
19. 19
The test drug (containing Litharge) is described as anti-inflammatory andThe test drug (containing Litharge) is described as anti-inflammatory and
has a quality of potentiating drug when applied topically (Ghani, 1921).has a quality of potentiating drug when applied topically (Ghani, 1921).
During our study we also found that the test drug is beneficial in psoriasisDuring our study we also found that the test drug is beneficial in psoriasis
total therapeutic response- 92% and has more absorption capacity intotal therapeutic response- 92% and has more absorption capacity in
comparison to normal skin .As mentioned in classical literature that thecomparison to normal skin .As mentioned in classical literature that the
drug is safe, we could also found less adverse effects with test drug indrug is safe, we could also found less adverse effects with test drug in
comparison to dithranol. The recurrence rate of psoriasis with dithranol iscomparison to dithranol. The recurrence rate of psoriasis with dithranol is
28% while observed less number side effects with test drug (i. e., 20%)28% while observed less number side effects with test drug (i. e., 20%)
also shows the better option of drug therapy with test drug.also shows the better option of drug therapy with test drug.
The above favouring remarks clearly shows that the drug is effective whenThe above favouring remarks clearly shows that the drug is effective when
applied topically. The drug seems to decrease proliferation ofapplied topically. The drug seems to decrease proliferation of
keratinocytes. The mechanism by which the test drug causes inhibitorykeratinocytes. The mechanism by which the test drug causes inhibitory
effects on Keratinocyts proliferation are not understood, and needs furthereffects on Keratinocyts proliferation are not understood, and needs further
clarification.clarification.
DISCUSSIONDISCUSSION
20. 20
CONCLUSIONCONCLUSION
It is concluded that topical application of thisIt is concluded that topical application of this
Herbo- mineral cream with phototherapy isHerbo- mineral cream with phototherapy is
having clinical significance in the treatment ofhaving clinical significance in the treatment of
Psoriasis with less side effects.Psoriasis with less side effects.