| CTRI Number |
CTRI/2023/07/054900 [Registered on: 06/07/2023] Trial Registered Prospectively |
| Last Modified On: |
06/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
An Ayurvedic management in ekakushtha vis a vis plaque psoriasis with vamana followed by kadhiratriphaladi kashaya & aragwadhadi kashaya |
|
Scientific Title of Study
|
An open label randomised comparative clinical study to evaluate the comined effect of khadirtriphaladi kashaya & aragwadhadi kashaya with vamana in the management of ekakushtha vis a vis plaque psoriasis |
| 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 Beena M D |
| Designation |
Associate professor |
| Affiliation |
JSS Ayurveda medical college and hospital |
| Address |
jss ayurveda medical college and hospital allanahalli mysuru department of kayachikitsa OPD 3
Mysore
KARNATAKA
570028
India |
| Phone |
9538367282 |
| Fax |
|
| Email |
drpbsreddy@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Beena M D |
| Designation |
Associate professor |
| Affiliation |
JSS Ayurveda medical college and hospital |
| Address |
jss ayurveda medical college and hospital allanahalli mysuru department if kayachikitsa OPD 3
KARNATAKA
570028
India |
| Phone |
9538367282 |
| Fax |
|
| Email |
drpbsreddy@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Megha P |
| Designation |
PG Scholar |
| Affiliation |
JSS Ayurveda Medical College and hospital |
| Address |
jss ayurveda medical college and hospital allanahalli mysuru department of kayachikitsa OPD 3
Mysore
KARNATAKA
570028
India |
| Phone |
6360300659 |
| Fax |
|
| Email |
meghaprakash2597@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jss Ayurveda Medical College and hospital allanahalli mysuru 570028 |
|
|
Primary Sponsor
|
| Name |
Dr Megha P |
| Address |
JSS Ayurveda medical college and hospital allanahalli mysuru |
| Type of Sponsor |
Other [Self] |
|
|
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 Beena M D |
JSS ayurveda medical hospital |
Jss Ayurveda medical college and hospital allanahalli mysuru 570028,department of kayachikitsa In OPD number 3
Mysore
KARNATAKA |
9538367282
drpbsreddy@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| jss Ayurveda medical college and hospital mysuru |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: EKAKUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Khadiratriphaladi kashaya, Reference: Sahasrayoga, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 15(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 48 Days, anupAna/sahapAna: Yes(details: -warm water), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Aragwadhadi kashaya, Reference: Astanaga hridaya sutra sthana15/17-18, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 15(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 48 Days, anupAna/sahapAna: Yes(details: -warm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects presenting with lakashanas of ekakushtha
Subjects presenting with isgns and symptoms of plaque psoriasis
Subjects between age group of 18 to 60 years irrespective of gender |
|
| ExclusionCriteria |
| Details |
Subjects with other systemic and metabolic disorders such as diabetic mellitus,hypertension,thyroid dysfunction and cardio vascular diseases which interfere with the course of treatment.
Subjects under cortucosteriods and immuno suppressant medications.
Subjects associated with other skin disease like fungal infection, eczema, dermatitis.
Pregnant women and lactating mother
Subjects unfit for vamana |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in scaling of ekakushtha vis a vis plaque psoriasi |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Complete reduction in signs & symptoms of ekakushta vis a vis plaque psoriasis |
6 weeks |
|
|
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
10/07/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/07/2023 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="5"
Days="30" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In ayurveda, all skin diseases have been named under the general term kushtha. It is considered as one among the Ashtamahagada. Ekakushtha is vatakapha pradhana kshudra kushtha. Prathyatma lakshanas includes aswedana, mahavastu, matsyashakalopamam, krishna arunavarna. By looking at the lakshanas it can be correlated to plaque psoriasis. Plaque psoriasis is the most common type of auto immune skin disease, the lesions are with red dry, slivery white scaling, which may be obivous after scraping the surface. The elbows, knees, and lower back are commonly involved. According to who, the worldwide prevalence of psoriasis is 2% to 3%. In india the prevalence of psoriasis ranges from 0.44% to 2.8%. In the contemporary system, the management of psoriasis is topical application,PUVA,corticosteriods and immunosuppresents which acts symptomatically In present scenario it is more oftenly exacerbated with psychological and social impact. Hence is the need of time to find out safe and effective treatment for psoriasis. In Ayurveda, acharya Charaka explained snehapana, vamana, virechana, raktamokshana as line of treatment for kushta. Since Ekakushta is a type of Kshudrakushta with vatakapha pradhana dosha, hence snehapana us the first line of treatment mentioned in clasics which does vatashamana and vamana is best for kapha dosha nirharana. Shamana chikitsa includes Khadiratriphaladi kashaya and Aragwadhadi kashaya which acts as kaphahara and kushthagna. In this present study effort is made to compare the efficacy of Kadhiratriphaladi kashaya and Aragwadhadi kashaya with vamana as kaphahara and kushthagna property. |