| CTRI Number |
CTRI/2018/02/011904 [Registered on: 13/02/2018] Trial Registered Retrospectively |
| Last Modified On: |
11/02/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Parangipattai Rasayanam in the management of kaalaanjagappadai(psoriasis) |
|
Scientific Title of Study
|
EVALUATION OF SAFETY AND EFFICACY OF A SIDDHA HERBAL PREPARATION PARANGIPATTAI RASAYANAM FOR KALANJAGAPADAI (PSORIASIS) AND ITS CLINICAL MANAGEMENT |
| Trial Acronym |
PRM(PARANGIPATTAI RASAYANAM) |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr V MAHALAKSHMI |
| Designation |
LECTURER |
| Affiliation |
NATIONAL INSTITUTE OF SIDDHA |
| Address |
NATIONAL INSTITUTE OF SIDDHA
DEPARTMENT OF SIRAPPU MARUTHUVAM
TAMBARAM SANATORIUM
CHENNAI
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9444519975 |
| Fax |
|
| Email |
rvmahalakshmi85@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr R S RAMASWAMY |
| Designation |
DIRECTOR GENERAL |
| Affiliation |
CENTRAL COUNCIL FOR RESEARCH IN SIDDHA |
| Address |
CENTRAL COUNCIL FOR RESEARCH IN SIDDHA
MINISTRY OF AYUSH
GOVT OF INDIA
ARUMBAKKAM CHENNAI
Chennai
TAMIL NADU
600106
India |
| Phone |
9444941489 |
| Fax |
|
| Email |
dr.rsramaswamy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr V MAHALAKSHMI |
| Designation |
LECTURER |
| Affiliation |
NATIONAL INSTITUTE OF SIDDHA |
| Address |
NATIONAL INSTITUTE OF SIDDHA
DEPARTMENT OF SIRAPPU MARUTHUVAM
TAMBARAM SANATORIUM
CHENNAI
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9444519975 |
| Fax |
|
| Email |
rvmahalakshmi85@gmail.com |
|
|
Source of Monetary or Material Support
|
| AYOTHIDOSS PANDITHAR HOSPITAL ROOM NO 3
NATIONAL INSTITUTE OF SIDDHA TAMBARAM SANATORIUM CHENNAI-47 |
|
|
Primary Sponsor
|
| Name |
NATIONAL INSTITUTE OF SIDDHA TAMBARAM SANATORIUM CHENNAI |
| Address |
NATIONAL INSTITUTE OF SIDDHA TAMBARAM SANATORIUM CHENNAI-47 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 V MAHALAKSHMI |
NATIONAL INSTITUTE OF SIDDHA |
DEPARTMENT OF SIRAPPU MARUTHUVAM ROOM NO3
NATIONAL INSTITUTE OF SIDDHA
CHENNAI
Kancheepuram
TAMIL NADU |
9444519975
rvmahalakshmi85@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
KALANJAGAPADAI (PSORIASIS), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
PARANGIPATTAI RASAYANAM |
8 gms of Parangipattai Rasayanam administered orally twice a day for a period of 40 days. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Erythema
Thickness
Scaling
Ithching :with or without itching
Auspitz sign +
Candle crease sign +
• Age : 20-60 years
• Sex : Both male and female
• Willing to give specimen of blood for the investigation whenever
required.
• Willing to participate in trial and signing consent by fulfiling the
condition of proforma. |
|
| ExclusionCriteria |
| Details |
Hypertension
Diabetes mellitus
Cardiac disease
Use of narcotic drugs
Pregnancy and lactation
Psoriasis with evidence of any other skin disease
Psoriatic arthropathy
Evidences of secondary infection in the lesions
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
GOOD OUTCOME- CLEARANCE OF LESIONS AND REDUCTION OF PASI SCORE FROM 3,4 TO 0,1.
MODERATE OUTCOME- CLEARANCE OF LESIONS AND REDUCTION OF PASI SCORE FROM 3,4 TO 1,2.
POOR OUTCOME- NO
CLEARANCE OF LESIONS OR NO REDUCTION OF PASI SCORE. |
40 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
05/10/2015 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
4 PAPERS |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Is is a single, non-randomized, open label trial to determine the efficacy and safety of Parangipattai Rasayanam in patients with kalanjagapadai. |