| CTRI Number |
CTRI/2024/06/069161 [Registered on: 19/06/2024] Trial Registered Prospectively |
| Last Modified On: |
30/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative study to see the effect of medicated oil and therapy in skin disease |
|
Scientific Title of Study
|
A comparative clinical trial to assess the effect of Marichyadi Taila and phototherapy in Mandal Kushtha with special reference to Twak Sharir |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrManoj Kumar Gurawa |
| Designation |
MD Scholar |
| Affiliation |
National Institute of Ayurveda |
| Address |
Department of Kriya Sharir
National Institute of Ayurveda Deemed to be University Jorawar Singh gate Amer road Jaipur Pin 302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
8742835724 |
| Fax |
|
| Email |
2021manojgurawa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Chhaju Ram yadav |
| Designation |
Professor and Head |
| Affiliation |
National Institute of Ayurveda |
| Address |
Department of Kriya Sharir
National Institute of Ayurveda Deemed to be University Jorawar Singh gate Amer road Jaipur Pin 302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
9469866101 |
| Fax |
|
| Email |
dr.yadavcr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Chhaju Ram yadav |
| Designation |
Professor and Head |
| Affiliation |
National Institute of Ayurveda |
| Address |
Department of Kriya Sharir
National Institute of Ayurveda Deemed to be University Jorawar Singh gate Amer road Jaipur Pin 302002
RAJASTHAN
302002
India |
| Phone |
9469866101 |
| Fax |
|
| Email |
dr.yadavcr@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda Deemed to be University Jorawar Singh gate Amer road Jaipur Pin 302002 |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda |
| Address |
Jorawar Singh gate Amer road Jaipur Pin 302002 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Manoj Kumar Gurawa |
National Institute of Ayurveda |
OPD No 3
National Institute of Ayurveda Deemed to be University Jorawar Singh gate Amer road Jaipur Pin 302002
Jaipur
RAJASTHAN |
8742835724
2021manojgurawa@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee National Institute of Ayurveda Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L409||Psoriasis, unspecified. Ayurveda Condition: KUSHTHAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Phototherapy | The affected part will be treated with 311 nm UVB produced by TL-01 bulbs as narrowband ultraviolet B (NB-UVB) for about 15-30 minutes.
3 sessions per week over a period of 6 weeks will be conducted. | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Marichyadi tailam,, Reference: Vangasen Kushtha 25/248,, Route: Topical, Dosage Form: Taila, Dose: 12(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: Local application oil as external application is mentioned as 5 to 12ml locally for twice a day. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with the classical features of Mandal Kushtha.
|
|
| ExclusionCriteria |
| Details |
Subjects suffering from known cases of other systemic disorders such as Cardiac Problems, Uncontrolled Diabetes mellitus, Uncontrolled Hypertension, Paralysis, Malignancy, HIV, HBsAg, Leprosy, etc.
Pregnant, lactating mothers |
|
|
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 |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in classical signs & symptoms of Mandal Kushta |
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)
|
10/10/2024 |
| 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="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
The
prevalence of Psoriasis in India as well as globally is quite high. The report
of the prevalence of Psoriasis in countries ranges from 0.09% to 11.43% and
making Psoriasis a serious global problem with at least 100 million individuals
affected worldwide. Prevalence studied from India are mostly hospital-based
which is reported to be 8%. Mandal
Kushtha or Psoriasis is difficult to cure as per Ayurveda as well
as modern means of treatment. Kushtha
or skin diseases are chronic i.e., Kashtasadhya. It affects cosmetically
which disturbs the patient from a psychological point of view. Modern
medical procedures and treatments have a lot of adverse effects on the Liver,
Kidney, Bone marrow, and Skin itself. Apart from this, generally, topical
steroids are expensive, and sometimes poor patients cannot afford this
treatment. Hence there is a need to search for better methods for the
management of Psoriasis.
AIM:
-
To assess the effect of Marichyadi
Taila and Phototherapy in Mandal Kushtha with special
reference to Twak Sharir.
OBJECTIVE:
-
Ø To
study the physio-pathology of Twak Sharir with special reference
to Mandal Kushtha.
Ø To
study the effect of Phototherapy on Mandal Kushtha
Ø To
compare the effect of Marichyadi Taila and Phototherapy in Mandal
Kushtha with special reference to Twak Sharir. |