| CTRI Number |
CTRI/2024/03/063436 [Registered on: 01/03/2024] Trial Registered Prospectively |
| Last Modified On: |
29/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [Dietary Intervention] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Dietetic management of psoriasis. |
|
Scientific Title of Study
|
Diet as a therapeutic tool for the management of chronic skin diseases with special reference to 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 |
Angkita Mishra |
| Designation |
PhD Scholar |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Vikriti Vigyan, Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University, Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8876090442 |
| Fax |
|
| Email |
angkita.mishra@bhu.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sisir Kumar Mandal |
| Designation |
Professor and Head of the Department |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Vikriti Vigyan, Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University, Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8697097984 |
| Fax |
|
| Email |
todrskmandal@bhu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Angkita Mishra |
| Designation |
PhD Scholar |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Vikriti Vigyan, Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University, Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8876090442 |
| Fax |
|
| Email |
angkita.mishra@bhu.ac.in |
|
|
Source of Monetary or Material Support
|
| Sir Sundarlal Hospital,Institute of Medical Sciences, Banaras Hindu University, Varanasi |
|
|
Primary Sponsor
|
| Name |
Institute of Medical Sciences, Banaras Hindu University, Varanasi |
| Address |
Department of Vikriti Vigyan, Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India |
| 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 Sisir Kumar Mandal |
Sir Sunderlal Hospital |
Department of Vikriti Vigyan, Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh
Varanasi
UTTAR PRADESH |
8697097984
todrskmandal@bhu.ac.in |
|
|
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:L400||Psoriasis vulgaris. Ayurveda Condition: EKAKUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Hriveradi Kwatha, Reference: Charaka Samhita, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:Dietary counseling will be provided to the patients along with a weekly diet chart for a total duration of 4 weeks.A cyclic menu is prepared for a week which will be repeated for 4 weeks until the completion of the study. Both vegetarian and non-vegetarian diet charts are prepared and they will be provided to the patients according to their preferences., Pathya/Apathya:yes, Pathya:1. Vegetarian diet chart:
A. SUNDAY-
Early morning- Fenugreek water; Breakfast- Dalia with moong dal; Mid-morning- Sprouted moong, amla; Lunch- Red rice, Roti, dal, neem leaves fried, bottle gourd fry; After lunch- Khadir water; Afternoon- Black tea with nutmeg powder; Evening- Moong dal chilla, pomegranate juice; Dinner- Red rice, Methi paratha, moong dal tadka, parwal fry.
B. MONDAY-
Early morning- Bitter gourd juice, Breakfast- Barley and spinach risotto; Mid-morning- Sprouted moong, cucu, Apathya:Heavy and sour food, mild, curd, meat of animals inhabiting marshy land, fish, jaggery, sesame are to be advised to be avoided along with any food preparations made by using these items. |
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with classical signs and symptoms of psoriasis will be included.
2. Patients between age groups 10-60 years will be included in this study.
3. Patients will be enrolled irrespective of gender, religion, occupation and socio-economic background.
|
|
| ExclusionCriteria |
| Details |
1. Patients not willing to participate in the study will be excluded.
2. Patients having Psoriatic lesions with superficial infections will be excluded.
3. Patients with malignant diseases will be excluded. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Psoriasis Area and Severity Index (PASI) scale. |
Day 0 and Day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Role of dietary management in dermatological disorders with special reference to Psoriasis. |
Day 0 and Day 30 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 4 |
|
Date of First Enrollment (India)
|
11/03/2024 |
| 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="2"
Months="0"
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
|
This is a two-arm, randomised, prospective study to evaluate the effect of dietary counselling on the management of psoriasis. The primary outcome will be evaluated based on changes in the Psoriasis Area and Severity Index (PASI) scale. The secondary outcome will be to study the comparative effect of diet and drugs in managing psoriasis. |