1
DOUBLE BLIND CONTROLLED DOUBLE BLIND CONTROLLED CLINICAL STUDIES OF A UNANI CLINICAL STUDIES OF A UNANI
HERBO-MINERAL CREAM IN PATIENTS HERBO-MINERAL CREAM IN PATIENTS OF PSORIASISOF PSORIASIS
Latif A. , Saleem A., Rahman S. Z. , & Latif A. , Saleem A., Rahman S. Z. , & Tahseen M. *Tahseen M. *
Department of Ilmul Advia, A. K. Tibbiya Department of Ilmul Advia, A. K. Tibbiya CollegeCollege
Aligarh Muslim University Aligarh. * Aligarh Muslim University Aligarh. * Department of Dermatology, J. N. Department of Dermatology, J. N. Medical College, A. M. U. Aligarh.Medical College, A. M. U. Aligarh.
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INTRODUCTIONINTRODUCTIONPsoriasis is a chronic remitting and relapsing scaly, Psoriasis is a chronic remitting and relapsing scaly, inflammatory and common skin disorder which is inflammatory and common skin disorder which is being treated by Unani System of Medicine ( a being treated by Unani System of Medicine ( a recognised traditional system by WHO ) from a recognised traditional system by WHO ) from a very long time*. Sources of Unani drugs for very long time*. Sources of Unani drugs for Psoriasis are herbs, animals & minerals.Psoriasis are herbs, animals & minerals.The present study, double - blind placebo The present study, double - blind placebo controlled, is done by using herbo-mineral controlled, is done by using herbo-mineral preparation as topical application in cases of 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.)
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Material & MethodsMaterial & MethodsDrugs:Drugs:
The formulation of Cream consists of the The formulation of Cream consists of the following ingredients:-following ingredients:-
1- Calomel (Hgcl- RasKapoor) 1- Calomel (Hgcl- RasKapoor) 5% 5% w/ww/w2- Camphor (2- Camphor (Cinnamomum camphora Cinnamomum camphora LinnLinn.. ) )
5% w/w5% w/w3- Litharge (Pbo- Murdarsang) 3- Litharge (Pbo- Murdarsang) 12% 12% w/ww/w4- 4- Psoralea corylifoliaPsoralea corylifolia Linn. oil Linn. oil 10% 10% w/ww/w5- Cream base 5- Cream base SQSQ
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Material and Method (Contd.)Material and Method (Contd.)STUDY PROTOCOLSTUDY PROTOCOL
((A) - Phsico-chemical studies: - Solubility, Smooth flow Test, pH, M. p., Absorption of A) - Phsico-chemical studies: - Solubility, Smooth flow Test, pH, M. p., Absorption of Cream by filter paper method & Tared Blade method:Cream by filter paper method & Tared Blade method:
(B) PATCH TEST (B) PATCH TEST (C) - Clinical Studies: - three groups of 25 patients of Psoriasis (Total numbers of (C) - Clinical Studies: - three groups of 25 patients of Psoriasis (Total numbers of Patients 75) of either sex and 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 (D) Mode of Administration of Cream: Topical Application of Cream followed by exposure to sunlight for 5 minutes in morning & eveningexposure to sunlight for 5 minutes in morning & evening
(E) Routine investigation and "Candle Grease" examination is made by scrapping of (E) Routine investigation and "Candle Grease" examination is made by scrapping of affected part of the skin. affected part of the skin.
(F) Evaluation of Cases after every 15 days up to 90 Days & Post treatment Followup (F) Evaluation of Cases after every 15 days up to 90 Days & Post treatment Followup is also done.is also done.
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Physico- Chemical Studies:Physico- Chemical Studies:General CharacteristicsGeneral Characteristics
SolubilitySolubility pHpH M. P.M. P. Smooth Smooth Flow TestFlow Test
ColourColour
(a) (a) Soluble in Soluble in chloroforchloroform & CCl4m & CCl4
b) b) Partially Partially Soluble in Soluble in Hot WaterHot Water
c)InSolublc)InSoluble in e in Alcohol, Alcohol, Water Water (Cold), (Cold), Pet-ether Pet-ether & ether& ether
Range-Range-6. 6- 6. 8 6. 6- 6. 8 (By Elico (By Elico pH pH Meter)Meter)IndicateIndicated d slightly slightly acidicacidic
Range Range fromfrom83 83 00C- 86 C- 86 00CC
By By ReichertReichertThermovarThermovarInstrumenInstrumentt
Uniform Uniform & Smooth & Smooth DistributiDistributionon
Blackish Blackish BrownBrown
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Drug absorption
0255075
100125150175
0 5 10 15 20 25 30 35 40
Time (Minute) Time Absorption Curve
(By Filter Paper Method)
Dru
g A
bsor
ptio
n
Drug absorption
7
Absorption Drug
0255075
100125150175
0 5 10 15 20 25 30 35 40Time (Minutes)
Drug
Abs
orpt
ion
AbsorptionDrug
Time Absorption Curve (By Tared Razor Blade)
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PATCH TEST OF HM-CREAM ON NORMAL PATCH TEST OF HM-CREAM ON NORMAL HUMAN SKIN OF FOREARMHUMAN SKIN OF FOREARM
S.No.S.No. SexSex
M M FF
IrritatiIrritationon
RednesRednesss(Rashes(Rashes))
HyperpigmentatHyperpigmentationion
BlisterBlister
112233445566778899
1010
MM
MMMM
MMMM
FF
FF
F F
F F FF
--------------------
----------
MildMild--------
--Light BlackishLight Blackish
--Light BlackishLight BlackishLight BlackishLight BlackishLight BlackishLight BlackishLight BlackishLight BlackishLight BlackishLight BlackishLight BlackishLight BlackishLight BlackishLight Blackish
--------------------
10%10% 80%80%
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PATCH TEST OF DITHRANOL ON NORMAL HUMAN PATCH TEST OF DITHRANOL ON NORMAL HUMAN SKIN OF FOREARMSKIN OF FOREARM
S.No.S.No. Age Age YearsYears
SexSex IrritatiIrritationon
RashesRashes HyperpigmentatioHyperpigmentationn
BlistersBlisters
1122334455667788991010
2828252515150606101028282020242417172121
M M FF
MM FFMMMM F F F F M MMM F F F F
++--++--++++----++--
MildMild----
MildMild----
MildMildMildMildMildMildMildMild
BlackishBlackishBlackishBlackish
Dark Blackish Dark Blackish Dark BlackishDark BlackishLight BlackishLight BlackishDark BlackishDark Blackish
BlackishBlackishBlackishBlackish
Light BlackishLight BlackishLight BlackishLight Blackish
----++++--++----++++
50 %50 % 60%60% 80%80% 70 %70 %
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CLINICAL STUDIESCLINICAL STUDIES
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Before Treatment
Cured (30 Days)
Cured (90 Days)
Before Treatment
1
2
12
3
4
Before Treatment
Cured (45 Days)
Cured (65 Days)
Before Treatment
13
Before Treatment
Cured (40 Days)
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A COMPARATIVE STATEMENT SHOWING TOTAL A COMPARATIVE STATEMENT SHOWING TOTAL RESPONSE OF THREE GROUPSRESPONSE OF THREE GROUPS
GroupGroupss
Compound Compound NameName
Total Total TherapeTherape
utic utic ResponsRespons
ee(a+b+c)(a+b+c)
CureCuredd
aa
RelivReliveded
bb
Partially Partially RelivedRelived
cc
No No ResponsRespons
ee
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22
33
HM Cream HM Cream (Test)(Test)
Dithranol Dithranol (Standard)(Standard)
PlaceboPlacebo(Pet- Jelly)(Pet- Jelly)
92 %92 %
88 %88 %
32 %32 %
68 %68 %
60 %60 %
NilNil
12 %12 %
16 %16 %
NilNil
12 %12 %
12 %12 %
32 %32 %
8 %8 %
12 %12 %
68 %68 %
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TOTAL RESPONSE OF HM CREAM, DIATHRANOL & TOTAL RESPONSE OF HM CREAM, DIATHRANOL & PET JELLYPET JELLY
0102030405060708090
100
HMCREAM
DITH. OINT.
PETJELLY
TOTAL RESPONSE
CURED
RELEIVED
PARTIALLYRELIVEDNO RESPONSE
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A COMPARATIVE STATEMENT SHOWING A COMPARATIVE STATEMENT SHOWING SIDE EFFECTS IN TEST & STANDARD SIDE EFFECTS IN TEST & STANDARD
GROUPSGROUPS
GroupsGroups Irritation (%)Irritation (%) Redness (%)Redness (%) Hyperpigmentation Hyperpigmentation (%)(%)
Blister Blister (%)(%)
TestTest MildMild ModeraModeratete
SeveSeverere
MilMildd
ModeraModeratete
SeveSeverere
Light Light BlackishBlackish
Dark Dark BlackishBlackish
66
(24.(24.6 )6 )
NilNil NilNil 2 2 (8)(8)
NilNil NilNil 1717
(68 )(68 )
NilNil NilNil
StandaStandardrd NilNil 55
(20)(20)
NilNil NilNil NilNil 77
(28) (28)
NilNil 10 10
(40)(40)
33
(12)(12)
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S. S. NoNo
Period Period of of
Relapse Relapse after after CuredCured
ChronicitChronicityy
AgeAge sexsex Site of Site of RecurrenceRecurrence
No. of RelapseNo. of Relapse
11
22
33
44
55
66
77
3 3 MonthsMonths
5 5 MonthsMonths
3 3 MonthsMonths
2 2 MonthsMonths
4 4 MonthsMonths
7 7 MonthsMonths
9 9 MonthsMonths
1-2 Yrs1-2 Yrs
2-5 Yrs2-5 Yrs
5-12 Yrs.5-12 Yrs.
12-24 12-24 Yrs.Yrs.
2-5 Yrs.2-5 Yrs.
5-12 Yrs.5-12 Yrs.
10-12 10-12 YrsYrs..
12 12 Yrs.Yrs.
31 31 Yrs.Yrs.
45 45 Yrs.Yrs.
47 47 Yrs.Yrs.
28 28 Yrs.Yrs.
35 35 Yrs.Yrs.
45 45 Yrs.Yrs.
MaleMale
MaleMale
FemaFemalele
FemaFemalele
MaleMale
FemaFemalele
MaleMale
Abd, legAbd, leg
Neck, ScalpNeck, Scalp
Neck, ScalpNeck, Scalp
BacksideBackside
ChestChest
Forearm & LegForearm & Leg
Scalp, Leg & Scalp, Leg & ArmArm
WholeWhole
Scalp OneScalp One
WholeWhole
WholeWhole
WholeWhole
WholeWhole
WholeWhole
RECURRANCE STATUS OF STANDARD GROUP (Dithranol RECURRANCE STATUS OF STANDARD GROUP (Dithranol Ointment)Ointment)
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RECURRANCE STATUS OF TEST GROUPRECURRANCE STATUS OF TEST GROUP (Herbo-mineral Cream)(Herbo-mineral Cream)
S. S. NoNo
Period Period of of
Relapse Relapse after after CuredCured
ChronicityChronicity AgeAge sexsex Site of Site of RecurrenceRecurrence
No. of RelapseNo. of Relapse
11
22
33
44
55
6 6 MonthsMonths
8 8 MonthsMonths
8 8 MonthsMonths
11 11 MonthsMonths
12 12 MonthsMonths
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 35 Yrs.Yrs.
38 38 Yrs.Yrs.
45 45 Yrs.Yrs.
50 50 Yrs.Yrs.
FemalFemalee
MaleMale
MaleMale
FemalFemalee
MaleMale
ScalpScalp
LegLeg
ForearmForearm
LegLeg
LegLeg
WholeWhole
Scalp OneScalp One
WholeWhole
WholeWhole
WholeWhole
No. Cases 5 (20 %)No. Cases 5 (20 %)
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The test drug (containing Litharge) is described as The test drug (containing Litharge) is described as anti-inflammatory and has a quality of potentiating anti-inflammatory and has a quality of potentiating drug when applied topically (Ghani, 1921). During our drug when applied topically (Ghani, 1921). During our study we also found that the test drug is beneficial in study we also found that the test drug is beneficial in psoriasis total therapeutic response- 92% and has more psoriasis total therapeutic response- 92% and has more absorption capacity in comparison to normal skin .As absorption capacity in comparison to normal skin .As mentioned in classical literature that the drug is safe, mentioned in classical literature that the drug is safe, we could also found less adverse effects with test drug we could also found less adverse effects with test drug in comparison to dithranol. The recurrence rate of in comparison to dithranol. The recurrence rate of psoriasis with dithranol is 28% while observed less psoriasis with dithranol is 28% while observed less number side effects with test drug (i. e., 20%) also number side effects with test drug (i. e., 20%) also shows the better option of drug therapy with test drug. shows the better option of drug therapy with test drug. The above favouring remarks clearly shows that the The above favouring remarks clearly shows that the drug is effective when applied topically. The drug seems drug is effective when applied topically. The drug seems to decrease proliferation of keratinocytes. The to decrease proliferation of keratinocytes. The mechanism by which the test drug causes inhibitory mechanism by which the test drug causes inhibitory effects on Keratinocyts proliferation are not effects on Keratinocyts proliferation are not understood, and needs further clarification.understood, and needs further clarification.
DISCUSSIONDISCUSSION
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CONCLUSIONCONCLUSION It is concluded that topical It is concluded that topical
application of this Herbo- mineral application of this Herbo- mineral cream with phototherapy is having cream with phototherapy is having clinical significance in the treatment clinical significance in the treatment of Psoriasis with less side effects. of Psoriasis with less side effects.
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Drug absorption
0255075
100125150175
0 5 10 15 20 25 30 35 40
Time (Minute) Time Absorption Curve
(By Filter Paper Method)
Dru
g A
bsor
ptio
n
Drug absorption
22
Absorption Drug
0255075
100125150175
0 5 10 15 20 25 30 35 40Time (Minutes)
Drug
Abs
orpt
ion
AbsorptionDrug
Time Absorption Curve (By Tared Razor Blade)