| CTRI Number |
CTRI/2024/04/065851 [Registered on: 16/04/2024] Trial Registered Prospectively |
| Last Modified On: |
15/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Management of Mandal Kushtha (PSORIASIS) through Panchkarma |
|
Scientific Title of Study
|
A comparative clinical study of Sarvanga Takradhara and Kushthaghana mahakashaya parisheka after Virechana karma in the management of Mandal Kushtha with special reference to 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 Gopesh Mangal |
| Designation |
Professor |
| Affiliation |
National Institute of Ayurveda Jaipur |
| Address |
PG Department of Panchakarma,
National Institute of Ayurveda,
Jorawar Singh Gate,
Amer Road, Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
8619849011 |
| Fax |
|
| Email |
gmangal108@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gopesh Mangal |
| Designation |
Professor |
| Affiliation |
National Institute of Ayurveda Jaipur |
| Address |
PG Department of Panchakarma,
National Institute of Ayurveda,
Jorawar Singh Gate,
Amer Road, Jaipur
RAJASTHAN
302002
India |
| Phone |
8619849011 |
| Fax |
|
| Email |
gmangal108@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gopesh Mangal |
| Designation |
Professor |
| Affiliation |
National Institute of Ayurveda Jaipur |
| Address |
PG Department of Panchakarma,
National Institute of Ayurveda,
Jorawar Singh Gate,
Amer Road, Jaipur
RAJASTHAN
302002
India |
| Phone |
8619849011 |
| Fax |
|
| Email |
gmangal108@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda, Jaipur |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda |
| Address |
National Institute of Ayurveda,
Jorawar Singh Gate,
Amer Road, Jaipur (Rajasthan) - 302002 |
| 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 Arju |
National Institute of Ayurveda Hospital |
OPD No.- 2 & 25 and PG Department of Panchakarma
National Institute of Ayurveda Hospital,
Jorawar Singh Gate,
Amer Road,
Jaipur
Jaipur
RAJASTHAN |
8890176007
arjurajaram@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee National Institute of Ayurveda |
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: MANDALAKUSHTHAH/KAPAJAKUSHTHAH, (2) ICD-10 Condition:L408||Other psoriasis. Ayurveda Condition: MANDALAKUSHTHAH/KAPAJAKUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | virecana-karma, विरेचन-करà¥à¤® | (Procedure Reference: A.H.Su 6/166, Ca.Chi.7/44, Dharakalpa , Ca.Su. 4/13, , Procedure details: 1.Deepana-Pachana (Panchakola Choorna (5 gm) twice a day before food)
2.Snehpana (Murchhita Go-Ghrita for 3-7 days as per Kostha)
3.Sarvanga Abhyanga by Dashamoola Taila and Sarvanga Swedana by the Dashamoola Kwatha will be done for 4 days.
4.Virechana Karma (Trivritadi Yog)
5.Sansarjana karma will be done as per the type of Shuddhi.
6.Takradhara
7.Parisheka (Kushthaghana mahakashaya))
| | 2 | Intervention Arm | Procedure | - | virecana-karma, विरेचन-करà¥à¤® | (Procedure Reference: Charak Chikitsa 7/44, Procedure details: 1) Medicine Name: Panchakola Choorna, Reference: Ca.Su. 4/13, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -
(2) Medicine Name: Murchhita Go-Ghrita, Reference: Ca.Su. 4/13, Route: Oral, Dosage Form: Ghrita, Dose: 50(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Ushana Jala), Additional Information: -
(3) Medicine Name: Trivritadi Yog, )
(1) Medicine Name: Trivritadi Yoga, Reference: Charak Chikitsa 7/44, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 80(ml), Frequency: od, Duration: 1 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients between 18 to 60 years of age.
2.Patients with the classical features of Mandal Kushtha (Plaque Psoriasis).
3.Patients not taking any other medicine for Mandal Kushtha (Plaque Psoriasis).
4.Patients fit for Virechana Karma.
5.Patients willing to sign consent form for trial. |
|
| ExclusionCriteria |
| Details |
1.Pregnant women and lactating mothers.
2.Patients suffering from systemic disorders as Cardiac Problem, Uncontrolled Diabetes mellitus, Uncontrolled Hypertension, Paralysis, Malignancy, HIV, HBsAg, Leprosy.
3.Patients suffering from Psoriatic Arthritis.
4.Patients unfit for Virechana Karma. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in PASI Score at Baseline (Day 0), Day 15, Day 30. |
four weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in ayurvedic parameters at Day 0, Day 15, Day 30. |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
15/05/2024 |
| 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="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
|
In Ayurveda, Kushtha is described as ‘Achikitasa’ and ‘Mahagada’. Although in Ayurveda most of the skin diseases were described under the heading of Kushtha . Kushtha is further classified as ‘Mahakushtha and Kshudrakushtha’. Acharaya Charaka mationed that all types of Kushtha are ‘Tridoshaja’ . In ‘Mandal Kushtha’ shows features like ‘Shwetam’ (white patches), ‘Raktam’ (red patch), Sthiram’(stable), ‘Styanam’(glossy), ‘Singdham’(unctuous), ‘Annyonasansaktam’ (combined or joined patches), ‘Uttsanmandalam’ (elevated above the normal skin layer and circular patches), ‘Kricha’ (difficult to heal). This are important clinical feature of Mandal Kushtha. This clinical features of ‘Mandal Kushtha’ are nearly corelated to Plaque Psoriasis. In modern medicine, Psoriasis is one of the most common dermatological disease, affecting up to 1% of world’s population. It is chronic inflammatory skin disorder. Clinically characterised by erythematous, sharply demarcated papules and round plaques covered by silvery micaceous scale. The etiology of Plaque Psoriasis is still poorly understood, but there is clearly genetic component to the disease. Hence it is non-contagious. Plaque Psoriasis is treated with glucocorticoids (methotrexate), topical vitamin D analogue (calcipotriene) and ultraviolet A and B spectrum with either oral or topical psoralens (PUVA) |