Clinical trial to evaluate the therapeutic medicine - thippiliyathi chooranam (internal) and valuzhuvai thylam (external) of psoriasis.
- Conditions
- psoriasis
- Registration Number
- CTRI/2014/07/004723
- Lead Sponsor
- National institute of siddha
- Brief Summary
**DISSERTATION TITLE:**
An openclinical trial to evaluate the Therapeutic Efficacy of Siddha Herbalformulation THIPPILIYATHI CHOORANAM (Internal drug) VALUZHUVAI THYLAM (Externaldrug) in the management of KALANJAGAPADAI (PSORIASIS).
**BRIEFSUMMARY:**
In Siddha system of medicine thediseases are classified into 4,448 types, among them the Skin disorders areclassified into 18 varieties by Siddhar Yugi munivar. The clinical features ofVirpodaga kuttam, Thethru kuttam, and Sadharu kuttam resembles in Kalanjagapadi(Psoriasis). In the textbook *SiddhaMaruthuvam Sirappu* states, Kalanjagapadai is a chronic non-infectious,recurrent, inflammatory disorder of the skin characterized by reddish, slightlyelevated patches covered with silvery white scales. The clinical features of Kalajagapadai are correlated to Psoriasis asdescribed in Modern Dermatology.
Psoriasisis common chronic and recurrentinflammatory disease of the skin, characterised by circumscribed, erythematousdry scaling plaques of various sizes. The lesions are usually covered bysilvery white lamellar scales. *(Ref:Andrews diseases of the skin, clinical dermatology pg no. 193).*
Prevalence ofPsoriasis varies from 0.1% to 3% in different parts of the world. In America1-2 %, 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 ingeneral population in India, but a study of patients attending clinics andhospitals showed a prevalence of 0.8% to 5.6%. The number of Kalanjagapadai patientsattending the National Institute of Siddha hospital is increasing day by day.
Patient isvery much agitated and subjected to physical and mental suffering. Howeverclinical symptoms can be relieved considerably with Siddha treatment. The mainingredients of Thippiliyathi Chooranam and Valuzhuvai Thylam also haveantivatha and antikuttam activity. Hence the author has chosen this diseasewith the trial drugs Thippiliyathi Chooranam (Internal) and Valuzhuvai Thylam(External).
**TREATMENT:**
**Internal Medicine:**Thippiliyathi Chooranam.
**Dosage:**2gms (twice a day) with ghee.
**Durationof 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 (350gm), Cow milk: Half padi, Tender coconut water: sufficient quantity, and Gingellyoil: Half padi.
**METHODOF PREPARATION:**
The abovementioned raw drugs are taken in equal amounts and made into fine powder.
**Methodof Purification of Raw Drugs:**
**Purification of Ilaikkalli Ver:** Washed with pure water anddried well. Ref: Sikicha RathanaDeepam Pg .no. 28.
**Purificationof 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 suthiseimuraiyagal pg.no.13.
**Purification of Thippili :** Soak it in lemon juice and then dried well. Ref: Saraku suthisei muraiyagal pg.no.7.
**Purificationof Nellivattral:** Boiled with milk then remove the seed and dried well.Ref:Sikicha Rathana Deepam pg no: 30.
**Purification of** **kadukaai:** Removethe seeds. Ref: Saraku suthiseimuraiyagal pg.no.4.
**Purification of Thaandrikaai:** Removethe seeds. Ref: Saraku suthisei muraiyagal pg. no: 7.
**Purification of Chukku:** Theouter layer is peeled off then cut into small pieces and dried in sunlight. Ref: Sarakusuthisei muraiyagal pg.no.6.
**Purification of Manjal**: The outer layer is peeled off thencut into small pieces and dried in sunlight. Ref: Sikicharathana Deepam pg.no.28.
**Purification of Maramanjal:** Theouter layer is peeled off then cut into small pieces and dried in sunlight. Ref:Sikicharathana Deepam pg.no.28.
**Purification of** **kaduku:** Cleanedand dried in sunlight for two days. Ref: Sikicharathana Deepam pg.no.30.
**Purification of** **Sevviyum:** Washed with pure water anddried well. Ref: SikicharathanaDeepam pg.no.28.
**Method of preparation:** The above mentioned drugs are ground with cow milkand 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 arefiltered.
**Drug Storage:**The trial drug **Thippiliyathi Chooranam** is stored in clean and dry glass bottles. **Valuzhuvai Thylam** isstored in clean and dry narrow mouthed bottles.
**Dispensing:**The Chooranam is given in powder form in packets and oil is given in petbottles.
**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.
**TESTSAND 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), Serumcholesterol.
Urine: Albumin, Sugar (F), (PP),Deposits.
Renal Function Tests: Blood Urea, SerumCreatinine and Uric acid.
Liver FunctionTests:Serum total bilirubin, Direct bilirubin, Indirect bilirubin, Serum Alkaline phosphatises,SGOT and SGPT.
**DATA COLLECTION:**
Required information will be collectedfrom each patient by using the following forms: Screening and selection Proforma, History taking Proforma, Clinicalassessment Proforma, Laboratory investigation Proforma, Consent form, Withdrawalform and Patient information sheet.
**STUDY ENROLLMENT**
Patients reporting at the OPD withclinical feature of erythematous patches, scaling, itching are chosen for enrolmentbased on the inclusion and exclusion criteria. The enrolled patients will beinformed about the study, trial drug, possible outcomes and the objectives ofthe study in the language and terms understandable to them and getting consentin the Informed Consent form. All these patients will be given unique registrationcard in which patients Registration number of the study, Address, Phone numberand Doctors phonenumber etc. so as to report easily whenever any complication arise. Complete clinicalhistory, complaints and duration, examination findings, all would be recordedin the prescribed Proformas. Patients will be advised to take the trial drugand to follow the appropriate dietary advice.
**CONDUCTOF THE STUDY:**
On the first day of the treatment Purgation will be given with Agasthiyar Kuzhambu in the early morning withSangan kuppi charu for balancing the deranged mukkutram. Then thetrial drugs Thippiliyathi Chooranam, internal drug and Valuzhuvai Thylam externaldrug will be given for 48 days. OPD patients are requested to visit thehospital once in 7 days. In each and every visit clinical assessment andprognosis will be recorded. For IPD patients the clinical assessment andprognosis will be recorded daily. Among the 20 IPD patients 10 patients will beadvised to do the prescribed Yoga technique along with trial drugs andremaining 10 patients will be treated with trial medicines only. Laboratoryinvestigations 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 upfor any recurrence. Defaulters will not be allowed to continue and will bewithdrawn from the study with fresh case being inducted.
**ADVERSE (or) SERIOUSEFFECTS MANAGEMENT:**
Ifthe trial patient develops any adverse reaction, he (or) she would be immediatelywithdrawn from the trial and he will be directed to take treatment in OPD ofNIS. It will also be reported to the Pharmaco vigilance committee of NIS.
**DATAANALYSIS:**
After enrolling thepatients in the study, a separate file for each patient will be maintained andall forms will be kept in the file. Study No. and patients No. will be enteredon the top of the file for easy identification. Whenever the patients visit OPDduring the study period, necessary entries will be made at the assessment forms.The screening forms will be filled separately. All forms will be further scrutinizedby Sr. Research Officer (Statistics) for logical errors and incompleteness ofdata to avoid any bias. No modification in the results is permitted forunbiased reports.
**OUTCOME**
**P**soriasis**A**rea and **S**everity **I**ndex (PASI)
Good outcome: Clearance oflesions and Reduction of PASI Score from 3, 4 to 0, 1.
Moderate outcome: Partialclearance and Reduction of PASI Score from 3, 4 to 1, 2.
Poor (or) Nil,NO reduction PASI Score or NOclearance of Clearance.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 40
Erythematous lesions Itching Scaling Willing to attend OPD or admission in IPD for the trial Willingness for consent Willing to give specimen of blood for the investigation Willing to take photograph before and after treatment.
Hypertension Diabetes mellitus Cardiac disease Peptic ulcer HIV Pregnancy and lactation Psoriasis with evidence of any other skin disease Psoriatic arthropathy Evidences of secondary infection in the lesions.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction of leasion determined by PASI Score Clearance of lesions and Reduction of PASI Score from 3,4 to 0,1.
- Secondary Outcome Measures
Name Time Method Redaction of clinical symptoms 0,1 2 3 the effect of yogatherapy on kalanjagapadai the effect of yogatherapy on kalanjagapadai
Trial Locations
- Locations (1)
National institute of siddha
🇮🇳Chennai, TAMIL NADU, India
National institute of siddha🇮🇳Chennai, TAMIL NADU, IndiaDr R RamyaPrincipal investigator8056255072ramyamanic@gmail.com