| CTRI Number |
CTRI/2024/09/074446 [Registered on: 26/09/2024] Trial Registered Prospectively |
| Last Modified On: |
14/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
application of chaturangula dala pralepa with and without panchnimba churna in scaly skin disease |
|
Scientific Title of Study
|
Evaluation of chaturangula dala pralepa with and without panchnimba churna in 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 Sanjay Kumar Tripathi |
| Designation |
Professor |
| Affiliation |
Rishikul Campus, Uttarakhand Ayurved University, Haridwar |
| Address |
OPD NO.1 Deptt. of Kayachikitsa, Rishikul Campus, Uttarakhand
Ayurved University, Haridwar Uttrakhand 249401 India
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9568004650 |
| Fax |
|
| Email |
sanjaytripathi.230@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Kumar Tripathi |
| Designation |
Professor |
| Affiliation |
Rishikul Campus, Uttarakhand Ayurved University, Haridwar |
| Address |
OPD NO.1 Deptt. of Kayachikitsa, Rishikul Campus, Uttarakhand
Ayurved University, Haridwar Uttrakhand 249401 India
UTTARANCHAL
249401
India |
| Phone |
9568004650 |
| Fax |
|
| Email |
sanjaytripathi.230@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Isha Sharma |
| Designation |
PG Scholar |
| Affiliation |
Rishikul Campus, Uttarakhand Ayurved University, Haridwar |
| Address |
OPD NO.1 Deptt. of Kayachikitsa, Rishikul Campus, Uttarakhand
Ayurved University, Haridwar Uttrakhand 249401 India
Hardwar
UTTARANCHAL
249401
India |
| Phone |
8279812268 |
| Fax |
|
| Email |
isha15996sharma@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rishikul Campus, Uttarakhand Ayurved University |
|
|
Primary Sponsor
|
| Name |
Uttarakhand Ayurved University |
| Address |
Uttarakhand Ayurved University Harrawala Dehradun uttarakhand |
| 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 Isha Sharma |
Rishikul campus,Uttarakhand Ayurved university Haridwar |
OPD NO.1 Deptt. of Kayachikitsa, Rishikul Campus, Uttarakhand
Ayurved University, Haridwar Uttrakhand 249401 India
Hardwar
Hardwar
UTTARANCHAL |
8279812268
isha15996sharma@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 |
(1) ICD-10 Condition:L409||Psoriasis, unspecified. Ayurveda Condition: EKAKUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: chaturangula dala pralepa, Reference: chakradutta, Route: Topical, Dosage Form: Kalka/ Paste , Dose: 00(NA), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: -in 40 patients, quantity sufficient of lepa mixed with water will be applied locally twice a day for 30 minutes. | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: panchnimba churna, Reference: bhaisajya ratnavali, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -water), Additional Information: -20 patients will be treated with panchnimba churna along with chaturangula dala pralepa for 90 days. |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient having sign and symptoms of Eka-Kushtha.
Patient of age between 20-60 years.
Patient willing to take part in Virechna Karma.
Positive sign of psoriasis like Auspitz sign, Candle grease sign, etc.
Chronicity less than 5 yrs.
|
|
| ExclusionCriteria |
| Details |
Known case of Malignancy, IHD, CHF, and any other vascular disease.
Uncontrolled Diabetes Mellitus, and Hypertension & other life threatening and Complicated diseases.
Pregnant and lactating women.
Any other co-existing skin diseases.
Chronicity more than 5yrs.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
improvement in following signs and symptoms of Eka-Kushtha (Psoriasis):
1. Aswednam
2. Mahavastu
3. Matsyashaklopam
4. Rukshta
5. Kandu
6. Auspitz sign
7. Candle grease sign
|
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| done on the basis of changes in clinical findings, relevant laboratory parameters and PASI score before during and at the end of trial. |
12 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 |
|
Date of First Enrollment (India)
|
30/09/2024 |
| 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="1"
Months="4"
Days="15" |
|
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 an autoimmune, chronic inflammatory skin disorder clinically characterized by erythematous, sharply demarcated papules & rounded plaques, covered by silvery micaceous scales. Skin lesions of psoriasis are variably pruritic. It is chronic and is well known for its course of remissions and exacerbations. The effect of Shodhana Chikitsa can be increased if it is followed by Shamana Chikitsa which include both Antarparimarjan and Bahiparimarjan Chikitsa. In Charaka Samhita Eka Kushtha is described as Vata-Kaphaj diseases. It has sign & symptoms i.e. Aswedanam, Mahavastu and Matsyashakalopamam, which can be compared with symptoms of Psoriasis.The worldwide burden of Psoriasis is 2%, and the prevalence of Psoriasis in India ranges from 0.44% - 2.8%. Chaturangula dala pralepa decreases the mitotic activity of skin leading to reduced skin flaking. Panchnimba churna is tikta rasa pradhana which works excellently in skin disorders. |