DISSERTATION TITLE:
An open
clinical trial to evaluate the Therapeutic Efficacy of Siddha Herbal
formulation THIPPILIYATHI CHOORANAM (Internal drug) VALUZHUVAI THYLAM (External
drug) in the management of KALANJAGAPADAI (PSORIASIS). BRIEF
SUMMARY: In Siddha system of medicine the
diseases are classified into 4,448 types, among them the Skin disorders are
classified into 18 varieties by Siddhar Yugi munivar. The clinical features of
Virpodaga kuttam, Thethru kuttam, and Sadharu kuttam resembles in Kalanjagapadi
(Psoriasis). In the textbook Siddha
Maruthuvam Sirappu states, Kalanjagapadai is a chronic non-infectious,
recurrent, inflammatory disorder of the skin characterized by reddish, slightly
elevated patches covered with silvery white scales. The clinical features of Kalajagapadai are correlated to Psoriasis as
described in Modern Dermatology. Psoriasis
is common chronic and recurrent
inflammatory disease of the skin, characterised by circumscribed, erythematous
dry scaling plaques of various sizes. The lesions are usually covered by
silvery white lamellar scales. (Ref:
Andrews diseases of the skin, clinical dermatology pg no. 193). Prevalence of
Psoriasis varies from 0.1% to 3% in different parts of the world. In America
1-2 %, South America 0.97%, Germany 1.3%, Great Britain 1.6%, Denmark 1.7%,
Sweden 2.3% of people found with Psoriasis. No studies have been done in
general population in India, but a study of patients attending clinics and
hospitals showed a prevalence of 0.8% to 5.6%. The number of Kalanjagapadai patients
attending the National Institute of Siddha hospital is increasing day by day. Patient is
very much agitated and subjected to physical and mental suffering. However
clinical symptoms can be relieved considerably with Siddha treatment. The main
ingredients of Thippiliyathi Chooranam and Valuzhuvai Thylam also have
antivatha and antikuttam activity. Hence the author has chosen this disease
with the trial drugs Thippiliyathi Chooranam (Internal) and Valuzhuvai Thylam
(External). TREATMENT: Internal Medicine:
Thippiliyathi Chooranam. Dosage:
2gms (twice a day) with ghee. Duration
of Treatment: 48 days. Ingredients: Equal quantity from Thippili (piper
longum), Milagu (piper nigrum), Chukku (zingiber
officinale), Kadugu
(brassica nigra), Muthakaasu (cyperus
rotundus), Nellivattral
(phyllanthus emblica), Manjal (curcuma longa), Kadukkaai (terminalia chebula),
Thaandrikaai (terminalia bellerica), Ilaikkalli (euphorbia ligularia), Maramanjal (coscinium
fenestratum), and Sevviyum (piper nigrum). External Medicine: Valuzhuvai Thylam. Dosage: Q.S.
Applied externally over the affected part. Ingredients:
Valuzhuvai (Celastrus paniculatus): 10 Palam (350 gm), Sombu: 10 Palam (350 gm),
Koraikizhangu (cyperus rotundus): 10 Palam (350 gm), Paeramutti: 10 Palam (350
gm), Cow milk: Half padi, Tender coconut water: sufficient quantity, and Gingelly
oil: Half padi. METHOD
OF PREPARATION: The above
mentioned raw drugs are taken in equal amounts and made into fine powder. Method
of Purification of Raw Drugs: Purification of Ilaikkalli Ver: Washed with pure water and
dried well. Ref: Sikicha Rathana
Deepam Pg .no. 28. Purification
of Muthakaasu: Cleaned it and dried well. Ref: Sikicha Rathana Deepam Pg.no.33. Purification of milagu: Soak it in vineger and dried it. Ref: Saraku suthisei
muraiyagal pg.no.13. Purification of Thippili : Soak it in lemon juice and then dried well. Ref: Saraku suthisei muraiyagal pg.no.7. Purification
of Nellivattral: Boiled with milk then remove the seed and dried well.
Ref: Sikicha Rathana Deepam pg no: 30. Purification of kadukaai: Remove
the seeds. Ref: Saraku suthisei
muraiyagal pg.no.4. Purification of Thaandrikaai: Remove
the seeds. Ref: Saraku suthisei muraiyagal pg. no: 7. Purification of Chukku: The
outer layer is peeled off then cut into small pieces and dried in sunlight. Ref: Saraku
suthisei muraiyagal pg.no.6. Purification of Manjal: The outer layer is peeled off then
cut into small pieces and dried in sunlight. Ref: Sikicharathana Deepam pg.no.28. Purification of Maramanjal: The
outer layer is peeled off then cut into small pieces and dried in sunlight. Ref:
Sikicharathana Deepam pg.no.28. Purification of kaduku: Cleaned
and dried in sunlight for two days. Ref: Sikicharathana Deepam pg.no.30. Purification of Sevviyum: Washed with pure water and
dried well. Ref: Sikicharathana
Deepam pg.no.28. Method of preparation: The above mentioned drugs are ground with cow milk
and are mixed with cow milk and tender coconut and then with gingelly oil
.These contents are subjected to heat until kadugu padham, then the thylam are
filtered. Drug Storage:
The trial drug Thippiliyathi Chooranam is stored in clean and dry glass bottles. Valuzhuvai Thylam is
stored in clean and dry narrow mouthed bottles. Dispensing:
The Chooranam is given in powder form in packets and oil is given in pet
bottles. YOGAM FOR SKIN DISEASE Padhmasanam (or) Sukhasanam,
Savaasanam, Paranayamam (Omkhara Pranayamam and Nithirai Pranayamam), and Dhyanam.
Ref:
(I) Yogam, By Dr. R. S. Ramaswamy, Siddha Maruthuvam, Special Areas. TESTS
AND ASSESMENTS A.
Clinical Assessment: Macules,
Papules, Pustules, Plaques, Erythema, Candle and grease sign, Auspitz sign, Itching,
and Keoebner phenomenon. B.
Siddha System Assessment: Naadi, Sparisam,
Naa, Niram, Mozhi, Vizhi, Malam, Moothiram: Neerkkuri and Neikkuri. C. Routine Investigations: Blood: Hb,
Total WBC Count, Polymorphs (Lymphocytes, Eosinophils, Monocytes, Basophils),
Total RBC count, ESR: (half hr. and 1 hr), Blood sugar (Fasting, PP), Serum
cholesterol. Urine: Albumin, Sugar (F), (PP),
Deposits. Renal Function Tests: Blood Urea, Serum
Creatinine and Uric acid. Liver Function
Tests:
Serum total bilirubin, Direct bilirubin, Indirect bilirubin, Serum Alkaline phosphatises,
SGOT and SGPT. DATA COLLECTION: Required information will be collected
from each patient by using the following forms: Screening and selection Proforma, History taking Proforma, Clinical
assessment Proforma, Laboratory investigation Proforma, Consent form, Withdrawal
form and Patient information sheet. STUDY ENROLLMENT
Patients reporting at the OPD with
clinical feature of erythematous patches, scaling, itching are chosen for enrolment
based on the inclusion and exclusion criteria. The enrolled patients will be
informed about the study, trial drug, possible outcomes and the objectives of
the study in the language and terms understandable to them and getting consent
in the Informed Consent form. All these patients will be given unique registration
card in which patients Registration number of the study, Address, Phone number
and Doctors phone number etc. so as to report easily whenever any complication arise. Complete clinical
history, complaints and duration, examination findings, all would be recorded
in the prescribed Proformas. Patients will be advised to take the trial drug
and to follow the appropriate dietary advice. CONDUCT
OF THE STUDY: On the first day of the treatment Purgation will be given with Agasthiyar Kuzhambu in the early morning with
Sangan kuppi charu for balancing the deranged mukkutram. Then the
trial drugs Thippiliyathi Chooranam, internal drug and Valuzhuvai Thylam external
drug will be given for 48 days. OPD patients are requested to visit the
hospital once in 7 days. In each and every visit clinical assessment and
prognosis will be recorded. For IPD patients the clinical assessment and
prognosis will be recorded daily. Among the 20 IPD patients 10 patients will be
advised to do the prescribed Yoga technique along with trial drugs and
remaining 10 patients will be treated with trial medicines only. Laboratory
investigations will be done on the first day and also at the end of the trial.
For IP patients, who are not in a position to stay in the hospital for a long time,
are advised to attend the OPD for further follow up. At the end of the trial,
the patients are advised to visit the OPD for further 2 months for follow up
for any recurrence. Defaulters will not be allowed to continue and will be
withdrawn from the study with fresh case being inducted. ADVERSE (or) SERIOUS
EFFECTS MANAGEMENT: If
the trial patient develops any adverse reaction, he (or) she would be immediately
withdrawn from the trial and he will be directed to take treatment in OPD of
NIS. It will also be reported to the Pharmaco vigilance committee of NIS. DATA
ANALYSIS: After enrolling the
patients in the study, a separate file for each patient will be maintained and
all forms will be kept in the file. Study No. and patients No. will be entered
on the top of the file for easy identification. Whenever the patients visit OPD
during the study period, necessary entries will be made at the assessment forms.
The screening forms will be filled separately. All forms will be further scrutinized
by Sr. Research Officer (Statistics) for logical errors and incompleteness of
data to avoid any bias. No modification in the results is permitted for
unbiased reports. OUTCOME Psoriasis
Area and Severity Index (PASI) Good outcome: Clearance of
lesions and Reduction of PASI Score from 3, 4 to 0, 1. Moderate outcome: Partial
clearance and Reduction of PASI Score from 3, 4 to 1, 2.
Poor (or) Nil, NO reduction PASI Score or NO
clearance of Clearance. |