| CTRI Number |
CTRI/2014/07/004758 [Registered on: 25/07/2014] Trial Registered Retrospectively |
| Last Modified On: |
17/07/2014 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
CLINICAL TRIAL TO STUDY THE EFFECTS OF DRUGS “PANCHAMUGA CHENDHURAM†(INTERNAL) AND “KUNDAVAATHI THAILAM†(EXTERNAL)IN PSORIASIS PATIENTS. |
|
Scientific Title of Study
|
AN OPEN PILOT STUDY ON THADIPPU PERUNOI (PSORIASIS) WITH THE TRIAL DRUG “PANCHAMUGA CHENDHURAM†(INTERNAL) AND “KUNDAVAATHI THAILAM†(EXTERNAL). |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S RAJALAKSHMI |
| Designation |
PG SCHOLAR |
| Affiliation |
GOVERMENT SIDDHA MEDICAL COLLEGE, CHENNAI. |
| Address |
Dr.S.RAJALAKSHMI, PG SCHOLAR, PG DEPARTMENT OF SIRAPPU MARUTHUVAM,
GOVERMENT SIDDHA MEDICAL COLLEGE,ARUMBAKKAM, CHENNAI.
Chennai
TAMIL NADU
600106
India |
| Phone |
9585600845 |
| Fax |
|
| Email |
dr.rajibsms23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S RAJALAKSHMI |
| Designation |
PG SCHOLAR |
| Affiliation |
GOVERMENT SIDDHA MEDICAL COLLEGE, CHENNAI. |
| Address |
Dr.S.RAJALAKSHMI, PG SCHOLAR, PG DEPARTMENT OF SIRAPPU MARUTHUVAM,
GOVERMENT SIDDHA MEDICAL COLLEGE,ARUMBAKKAM, CHENNAI.
Chennai
TAMIL NADU
600106
India |
| Phone |
9585600845 |
| Fax |
|
| Email |
dr.rajibsms23@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M MOHAMED MUSTHAFA |
| Designation |
LECTURER, HOD, GUIDE |
| Affiliation |
GOVERMENT SIDDHA MEDICAL COLLEGE, CHENNAI. |
| Address |
Dr.M.MOHAMED MUSTHAFA MD(S),
HEAD OF THE DEPARTMENT,
PG DEPARTMENT OF SIRAPPU MARUTHUVAM,GOVERMENT SIDDHA MEDICAL COLLEGE,
CHENNAI.
Chennai
TAMIL NADU
600106
India |
| Phone |
9444190077 |
| Fax |
|
| Email |
drmmohamedmusthafa@gmail.com |
|
|
Source of Monetary or Material Support
|
| GOVERMENT SIDDHA MEDICAL COLLEGE CHENNAI |
|
|
Primary Sponsor
|
| Name |
GOVERMENT SIDDHA MEDICAL COLLEGE CHENNAI |
| Address |
GOVERMENT SIDDHA MEDICAL COLLEGE,ARUMBAKKAM, CHENNAI. |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr S RAJALAKSHMI |
GOVERMENT SIDDHA MEDICAL COLLEGE CHENNAI |
OPD and IPD OF ARINGAR ANNA HOSPITAL, GOVERMENT SIDDHA MEDICAL COLLEGE ARUMBAKKAM,CHENNAI
Chennai
TAMIL NADU |
9585600845
dr.rajibsms23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, GOVERNMENT SIDDHA MEDICAL COLLEGE, CHENNAI. |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
PSORIASIS, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
PANCHAMUGA CHENDHURAM(INTERNAL) |
20 Patients treated with PANCHAMUGA CHENDHURAM,50 mg, oral administration,Twice daily,for 48 days. |
| Intervention |
PANCHAMUGA CHENDHURAM(internal), KUNDAVAATHI THAILAM(external) |
20 patients treated with both PANCHAMUGA CHENDHURAM(internal), KUNDAVAATHI THAILAM(external). PANCHAMUGA CHENDHURAM,50 mg, oral administration,Twice daily,for 48 days.
KUNDAVAATHI THAILAM for external application, twice daily for 48 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patches with Scaling.
Auspitz Sign +
Koebner’s Phenomenon +
Willing to give specimen of blood for the investigation whenever required.
Willing to give photographs before and after treatment (Ensuring confidentiality)
|
|
| ExclusionCriteria |
| Details |
Hypertension,Diabetes mellitus,Narcotic addicts,Psoriatic arthropathica,Cardiac disease
Leprosy,Peptic ulcer,SLE,progressive systemic sclerosis,Evidences of secondary infection in the lesions,Pregnancy, lactation,HIV
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcome is mainly assessed by reduction in clinical symptoms like itching and scaling.
PASI Score (Psoriasis area severity index)
|
12 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • Secondary outcome is assessed by comparing the safety parameters before and after treatment. |
12 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
24/03/2014 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not yet publised |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Psoriasis is a lifelong, chronic, immune mediated, inflammatory skin condition affecting 2% of general population. It is common in both men and women. The typical skin lesions are well defined, red, indurated plaques with silvery scales. However The effective treatment of this disease is limited. The Siddha herbo-mineral formulation “Panchamuga chendhuram†(PMC) and Siddha polyherbal formulation “Kundavaathi thailam†mentioned in classical siddha literatures indicated for all skin diseases are selected for this study. It is an open labed comparitive study on psoriasis patients with the trial drug “PMC†(internal) and “Kundavaathi thailam†(external). PMC is given for 20 patients, 50mg dosage, twice a day for 48 days, and for another 20 patients PMC is given along with Kundavaathi thailam for external use. PMC Contains Purified Hydragyrum, Purified Sulphur, Purified Mercuric II sulphide, Purified Mercuric chloride, Purified Arsenic trisulfide, Piper betel leaf juce. Kundavaathi thailam contains azima tetracantha, alangium salvifolium, smilax china, aegle mamelos,withania somnifera, alpinia galangal,picrorhiza scropulariflora, helicteres isora, santalum album, piper nigrum, scindapsus officinalis, styrax benzoin, Gingilley oil, Cow’s milk The Physicochemical analysis of PMC was done in SAIF, IIT MADRAS. SEM analysis reveals the presences of particle size ranges from ~50nm- ~500nm. SEM with EDAX indicated the considerable amount of sulphur, mercury, arsenic and oxygen. In FTIR the functional groups such as carbonyl group, hydroxyl group, nitrogen compound are present. These functional groups have specific effect on skin. In ICPOES Presence of heavy metals such as Hg, As, Pd, Cd, Fe, Cu are in considerable limits. Hence , the present study have to be carried out to evaluate the efficacy and saftey of the drugs “PMCâ€, “Kundavaathi thailamâ€. |