| CTRI Number |
CTRI/2024/09/073578 [Registered on: 09/09/2024] Trial Registered Prospectively |
| Last Modified On: |
03/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A study to determine the efficacy of Siddha prebiotic drug Panchadeepakini chooranam in Psoriasis |
|
Scientific Title of Study
|
A comparative open label study to evaluate the effficacy of Siddha prebiotic Panchadeepakini chooranam in management of Psoriasis(Kalanjagappadai)among patients attending special OPD at Government Siddha Medical College Hospital-A pilot study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Atchaya Selvaraju |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College ,Chennai |
| Address |
Department of Pothu Maruthuvam,Government Siddha Medical College Chennai,Arumbakkam,Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9080261016 |
| Fax |
|
| Email |
uvasrikarthikaa812@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr G Ujjeevanam |
| Designation |
Professor, Department of PG Pothu Maruthuvam |
| Affiliation |
Government Siddha Medical College, Chennai |
| Address |
Department of Pothu Maruthuvam,Government Siddha Medical College Chennai,Arumbakkam,Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9884175653 |
| Fax |
|
| Email |
ujjeevanam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr G Ujjeevanam |
| Designation |
Professor, Department of PG Pothu Maruthuvam |
| Affiliation |
Government Siddha Medical College, Chennai |
| Address |
Department of Pothu Maruthuvam,Government Siddha Medical College Chennai,Arumbakkam,Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9884175653 |
| Fax |
|
| Email |
ujjeevanam@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Siddha Medical College,Chennai.
Anna Arch Road,
Arumbakkam,
Chennai-600106 |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College Chennai |
| Address |
no-6,Anna Arch Road,Arumbakkam,Chennai-600106 |
| 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 Atchaya Selvaraju |
Government Siddha Medical College, Chennai. |
Department of PG Pothu Maruthuvam,Room No S1
Chennai
TAMIL NADU |
9080261016
uvasrikarthikaa812@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Government Siddha Medical College ,Arumbakkam, Chennai-600106 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L409||Psoriasis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Gandhaga rasayanam,Parangipattai chooranam,Parangipattai kudineer,Vetpalai thylam. |
A set of internal medicines consisting of Gandhaga rasayanam-500 mg twice a daywith milk,Parangipattai chooranam 1 gram twice a day with milk,Parangipattai kudineer 30 ml once a day will be given.Vetpalai thylam is given for external application. |
| Intervention |
Panchadeepakini Chooranam |
35 g of each raw drugs-Purified Zingiber officinale,Piper nigrum,Piper longum,Ellataria cardomom,Cuminum cyminum will be mildly roasted,powdered,sieved seperately and preserved in an airtight container.1 gram of medicine will be given with honey as an add on intervention along with special OPD medicines for 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
60.00 Day(s) |
| Gender |
Both |
| Details |
Patients with moderate and severe psoriasis characterized by PASI score greater than or equal to 5 |
|
| ExclusionCriteria |
| Details |
Known case of Diabetes Mellitus
Pregnant and lactating mothers |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The rate of acheivement of PASI 50 or PASI 75 will be compared in both the study groups |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To estimate the reduction of investigatory parameters |
3 months |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
16/09/2024 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [uvasrikarthikaa812@gmail.com].
- For how long will this data be available start date provided 01-12-2024 and end date provided 01-12-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Psoriasis is a disease of T cells with interplay of genetic factors and environmental influences such as infections and drugs. Gut dysbiosis is associated with altered immune response promoting thedevelopment of skin diseases like psoriasis, atopic dermatitis, acne vulgaris, dandruff and skincancer.These days probiotics and prebiotics are used as novel therapeutic approaches for psoriasis. Spices displayed prebiotic like activity by promoting the beneficial bacteria and suppressing growth of pathogenic bacteria suggesting their potential role in regulation of intestinal microbiota and enhancement of gastrointestinal health. Qing et al states that spices extracts enhanced the growth of Bifidobacterium spp and Lactobacillus spp. All spices exhibited inhibitory activity against selected Ruminococcus spp. Siddha medicines possess spices as their most essential components. Panchadeepakini chooranam is made of five spices namely Zingiber officinale, Piper nigrum, Piper longum, Elletaria cardomom, Cuminum cyminum. According to researches, the spices present in panchadeepakini chooranam increases the abundance of gut microbe Bifidobacterium, reduces inflammation of intestinal epithelium due to gut microbial dysbiosis. Since development of Psoriasis is associated with gut dysbiosis,it is considered to evaluate the efficacy of Panchadeepakini chooranam in Psoriasis patients attending special OPDas an add on treatment in accelerating the achievement of PASI 50 or PASI 75. A supportive invitro study was asked to completed before starting the clinical trial. I have completed the preclinical invitro study and now registering for ctri number to proceed with clinical study |