| CTRI Number |
CTRI/2024/11/076725 [Registered on: 12/11/2024] Trial Registered Prospectively |
| Last Modified On: |
09/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ayurvedic treatment of Kushta by Patoladi kwath. |
|
Scientific Title of Study
|
Randomized controlled clinical trial to evaluate the efficacy of Patoladi kwatha in the management of Eka Kushtha (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 Krushna Zod |
| Designation |
PG Student |
| Affiliation |
CSMSS Ayurved Mahavidyalay,Kanchanwadi |
| Address |
OPD Number13 Department of Kayachikitsa CSMSS Ayurvedic Hospital Kanchanwadi Chhatrapati sambhaji nagar 431011
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
7028500431 |
| Fax |
|
| Email |
krushnazod321@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shrikant Deshmukh |
| Designation |
Professor & HOD |
| Affiliation |
Chatrapati Shahu Maharaj Shikshan sanstha Ayurved Mahavidyalaya Kanchanwadi 431011 |
| Address |
OPD Number13 Department of Kayachikitsa CSMSS Ayurvedic Hospital Kanchanwadi Chhatrapati sambhaji nagar 431011
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
9921553999 |
| Fax |
|
| Email |
dr.shrikantgdeshmukh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shrikant Deshmukh |
| Designation |
Professor & HOD |
| Affiliation |
Chatrapati Shahu Maharaj Shikshan sanstha Ayurved Mahavidyalaya Kanchanwadi 431011 |
| Address |
OPD Number13 Department of Kayachikitsa CSMSS Ayurvedic Hospital Kanchanwadi Chhatrapati sambhaji nagar 431011
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
9921553999 |
| Fax |
|
| Email |
dr.shrikantgdeshmukh@gmail.com |
|
|
Source of Monetary or Material Support
|
| CSMSS Ayurved Mahavidyalaya,Kanchanwadi,Chhatrapati sambhaji nagar 431011 |
|
|
Primary Sponsor
|
| Name |
Dr Krushna Zod |
| Address |
OPD Number13 Department of Kayachikitsa Chhatrapati shahu maharaj shikshan sanstha Ayurvedic Hospital Kanchanwadi Chhatrapati sambhaji nagar 431011 |
| Type of Sponsor |
Other [SELF sponsered] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| SELF |
OPD Number13,Department of Kayachikitsa ,CSMSS Ayurvedic Hospital Kanchanwadi,Chhatrapati sambhaji nagar,431011 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Krushna Zod |
Chhatrapati Shahu Maharaj Ayurved Mahavidyalay and Hospital |
OPD Number13,Department of Kayachikitsa ,CSMSS Ayurvedic Hospital Kanchanwadi,Chhatrapati sambhaji nagar,431011
Aurangabad
MAHARASHTRA |
7028500431
krushnazod321@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CSMSS Ayurveda mahavidayalaya va rugnalaya Kanchanwadi Aurangabad 431011 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L088||Other specified local infections of the skin and subcutaneous tissue. Ayurveda Condition: EKAKUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Aarogya vardhini Vati, Reference: Rasa Ratna Samuchhya 20 th chapter shloka 87-90, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -Koshna Jala), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Patoladi Kwath, Reference: Bharat Bhaishajya Ratnavali third part 3745, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Patients Having Clinical Features Such As Mahavastu and Matsyashakalopama ,krushnaauna varna.
Patients Showing Sign And Symptoms Of Psoriasis less than 1 year .
|
|
| ExclusionCriteria |
| Details |
-Patients having sign and symptoms of eczema, lichen planus, actopic dermatitis, contact dermatitis, tinea corporis.
-Patients with severe systemic diseases.
-Patients with pregnancy and lactation.
-Patients suffering from psoriatic arthritis.
|
|
|
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
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
MASTYASHAKAOLPAM (Scaling) will reduce.
- MAHAVASTU (Degree of Involvement) will decrease.
- KRUSHNAARUNA VARNA (Erythema) will reduce.
|
15th,30th,45th day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Size Of Patch will be measured by vernier caliper and it will decrease.
PASI Score ( Psoriasis Area Severity Index) will decrease.
|
15th,30th,45th day |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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)
|
21/11/2024 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - NO
|
|
Brief Summary
|
Psoriasis is chronic inflammatory skin disorder clinically characterized by erythematous
, Sharply demarcated papules and rounded plaques, covered by silvery micaseous scale.The skin lesion of psoriasis are variably pruritic. In Ayurveda the twak rogas are known by general
term kushtha derived from the word kushu which means that it comes out from the
inner part to outer part and destroys the organ of body, therefore it is called
kustha. In ayurveda Eka Kushtha is considered as one of the most important Twaka Roga and
the patient facing lots of problems to manage this disease.Strotodrushti
lakshan and Etiopathogenesis of Eka Kushtha observe and explained so as to
correct the Strotodrushti by Patoladi Kwath and also Samprapti Bhangatmak
chikitsa. Also
the management of patient at OPD Level with cheap and effective remedies which
should not hamper the daily routine of the patient.The
Patoladi Kwatha is advised in Bharat
Bhaishajya Ratnavali which is Tridoshshamak which is used in kwath form which
may produce potent and deeper action against Eka Kushtha. Therefore study is undertaken to evaluate the effect of Ptoladi
Kwath in Management of Eka Kushtha. |