| CTRI Number |
CTRI/2023/09/058049 [Registered on: 26/09/2023] Trial Registered Prospectively |
| Last Modified On: |
04/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Treatment of Palmoplantar psoriasis with Ayurvedic medicine |
|
Scientific Title of Study
|
Assessment of Efficacy of Virechanottara Pathyadi Pandi and Pathyadi lepa Over Narayana Rasa And Sikthadi lepa in the Management of Vipadika Kushta(Palmoplantar Psoriasis)-An Open Labelled Comparative RCT 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 Bhagyalakshmi Badiger |
| Designation |
PG studies in kayachikitsa |
| Affiliation |
Pandith Taranath Government Ayurvedic Medical College and Hospital Dr Rajkumar Road Bellary |
| Address |
Department of PG Studies in Kayachikitsa room no 3 Pandith Taranath Government Ayurvedic Medical College and Hospital Dr Rajkumar Road Bellary
Bellary KARNATAKA 583101 India |
| Phone |
9886257363 |
| Fax |
|
| Email |
bhagyalaxmibadiger1996@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Madhava Diggavi |
| Designation |
MD(Ayu) Professor and Head |
| Affiliation |
Pandith Taranath Government Ayurvedic Medical College and Hospital Dr Rajkumar Road Bellary |
| Address |
Department of PG Studies in Kayachikitsa room no 3 Pandith Taranath Government Ayurvedic Medical College and Hospital Dr Rajkumar Road Bellary
Bellary KARNATAKA 585103 India |
| Phone |
9844094290 |
| Fax |
|
| Email |
drmvdbly@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Bhagyalakshmi Badiger |
| Designation |
PG studies in kayachikitsa |
| Affiliation |
Pandith Taranath Government Ayurvedic Medical College and Hospital Dr Rajkumar Road Bellary |
| Address |
Department of PG Studies in Kayachikitsa room no 3 Pandith Taranath Government Ayurvedic Medical College and Hospital Dr Rajkumar Road Bellary
Bellary KARNATAKA 583101 India |
| Phone |
9886257363 |
| Fax |
|
| Email |
bhagyalaxmibadiger1996@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pandith Taranath Government Ayurvedic Medical College and Hospital Bellary Dr Rajkumar Road Bellary 583101 |
|
|
Primary Sponsor
|
| Name |
Pandith Taranath Govt Ayurvedic Medical College and Hospital Bellary |
| Address |
Pandith Taranath Govt Ayurvedic Medical College and Hospital Bellary Dr Rajkumar Road Bellary |
| 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 Bhagyalakshmi badiger |
Taranath goverment ayurvedic medical college and hospital bellary 583101 |
Department of PG Studies in Kayachikitsa room no 3 Pandith Taranath Government Ayurvedic Medical College and Hospital Dr Rajkumar Road Bellary Bellary KARNATAKA |
9886257363
bhagyalaxmibadiger1996@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Taranath government Ayurvedic Medical College Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L989||Disorder of the skin and subcutaneous tissue, unspecified. Ayurveda Condition: VIPADIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Pathyadi Pindi, Reference: Ashtanga Hridaya,Kushta chikitsa, Route: Oral, Dosage Form: Churna/ Powder, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Sukhoshna Jala), Additional Information: - | | 2 | Intervention Arm | Procedure | - | virecana-karma, विरेचन-करà¥à¤® | (Procedure Reference: Ashtanga Hradaya, Procedure details: SNEHA PANA:With Murchita tila taila 40ml test dose,75ml,100ml,125ml in arohana krama for 3 days with sukhoshna jala anupana.
VISHRAMA KALA:Sarvanga abhyanga with murchita tila taila followed by mrudu bhashpa sweda for 3 days.
VIRECHANA YOGA:Triphaladi yoga with 100ml of Triphala kwata along with 3gms of Trivrut churna & 3 gms of Dantimula churna,for one day,in the morning time on empty stomach fallowed by half an hourly one cup warm water.
SAMSARJNA KRAMA:with peyadi kalpa according to shud) (1) Medicine Name: Narayana Rasa, Reference: Bhaishyaja Ratnavali, Bhagandara Rogadhikara, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 250(mg), Frequency: bd, Duration: 30 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients fulfilling the ayurvedic and dermatological criteria of diagnosis of Palmoplantar Psoriasis with no restrictions of gender and religion.
Patients who have signed informed consent form.
Patients between the age group of 20-60 years.
Patients who are fit for virechana. |
|
| ExclusionCriteria |
| Details |
Lactating and pregnant women.
Subject suffering from chronic systemic severe diseases. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| correction of subjective parameters like panisputana,padasputana,daha, Teevra vedana |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improve the quality of life |
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
05/10/2023 |
| 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="1" Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Vipadika is kshudra kushta, vata and kapha dosha are predominant doshas involved with symptoms like pani pada sphutana(cracks in palms and soles), teevra vedana(severe pain), saragapidika(red patches) over palm and soles.Kandu(itching), daha(burning sensation), ruja(pain) specially over pada. The symptoms of vipadika are similar to palmoplantar psoriasis, which is long lasting auto immune disease characterised by scaly erythematous plaques on palms and soles accompanied with scaling and keratinization,causing social isolation, cosmetic and psychological embarrassment as well as difficulties in leading social life. The palmoplantar variant of psoriasis comprises 3%-4% of all cases of psoriasis, which affects 2%-5% of population. People may experience exacerbations brought on by social changes, household work and detergents.Infact, palmoplantar psoriasis is more common amongst former, manual labourers and housewives. The treatment in modern dermatology is not satisfactory with more chances of recurrence. Immunomodulators like thalimide, lenaliomide and topicals are usually preferred. These drugs can cause side effects such as drowsiness, low blood cell counts, neuropathy and also increased risk of serious blood clots. Kushta is considered as rakta pradoshaja vikara, virechana followed by shaman rasayana aushadhi and lepa containing kushtahara dravyas plays vital role in the treatment of kushta. Virechana with triphaladi yoga, which is specially mentioned in kushta chikitsa having ingredients like trivrut churna and dantimula churna acts as rechana. Pathyadi pindi rasayana contains pathya, tila, guda and bhallataka which are kushtagna, kandughna and vishahara dravyas. Pathyadi lepa and Sikthadi lepa acts locally over the lesion redusing its itching and cracks penetrating deep into the skin. Narayana rasa contains shuddha parada, shuddha gandhaka, tamra bhasma,chavya, gajapippali it acts like vruna ropana,sputana hara and kadughna.
|