| CTRI Number |
CTRI/2024/06/069477 [Registered on: 25/06/2024] Trial Registered Prospectively |
| Last Modified On: |
25/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Patola-Nimbadi Basti in the Management of Psoriasis w.s.r. to Ekakushtha |
|
Scientific Title of Study
|
An Open Label Clinical Non-Randomized Study to Evaluate the Efficacy of Patola-Nimbadi Basti in the Management of Psoriasis w.s.r. to Ekakushtha |
| 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 Himanshu |
| Designation |
M D Panchkarma scholar |
| Affiliation |
Institute for Ayurved Studies and Research Umri Road Sector 08 Kurukshetra Haryana 136118 |
| Address |
Room No. 69, First Floor, Department of Panchkarma, Institute for Ayurved Studies and Research,Shri krishna Ayush University,Sector 8, Umri Road, Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
7988781308 |
| Fax |
|
| Email |
himanshuvaday@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Ashish Mehta |
| Designation |
Professor |
| Affiliation |
Institute for Ayurved Studies and Research Umri Road Sector 08 Kurukshetra Haryana 136118 |
| Address |
Room No 67,First Floor PG Department of Panchkarma, Institute for Ayurved Studies and Research, Shri Krishna Ayush University, Sector 8, Umri Road, Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
8950375285 |
| Fax |
|
| Email |
chairperson.pk@skau.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Himanshu |
| Designation |
M D Panchkarma Scholar |
| Affiliation |
Institute for Ayurved Studies and Research Umri Road Sector 08 Kurukshetra Haryana 136118 |
| Address |
Room No. 69, First Floor, Department of Panchkarma, Institute for Ayurved Studies and Research,Shri krishna Ayush University,Sector 8, Umri Road, Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
7988781308 |
| Fax |
|
| Email |
himanshuvaday@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute for Ayurved Studies and Research,Shri krishna Ayush University Umri Road Sector 08 Kurukshetra Haryana 136118 |
|
|
Primary Sponsor
|
| Name |
Institute for Ayurved Studies and Research Umri Road Kurukshetra Haryana |
| Address |
Institute for Ayurved Studies and Research Shri Krishna Ayush University sector 08 Umri Road Kurukshetra Haryana 136118 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 Himanshu |
Institute for Ayurved Studies and Research Umri Road Sector 08 Kurukshetra Haryana 136118 |
Opd No 29 First Floor Department of Panchkarma Institute for Ayurved Studies and Research Umri Road Sector 08 Kurukshetra Haryana 136118
Kurukshetra
HARYANA |
7988781308
himanshuvaday@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 | Procedure | - | bastikarma/vastikarma, बसà¥à¤¤à¤¿à¤•à¤°à¥à¤®/वसà¥à¤¤à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Charak Samhita , Procedure details: Kala Basti in which total 16 Basti having 10 Anuvasana Basti of Goghrita and 6 Patol-Nimbadi Niruha basti were given to patient.Niruha Basti shall be given on empty stomach and Anuvasana
Basti shall be given immediately after morning meal.)
(1) Medicine Name: Patol-Nimbadi Niruha, Reference: Ashtanga Sangrah kalpasthan 4 Shloka 24, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 400(ml), Frequency: od, Duration: 6 Days |
|
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects presenting with clinical features of Psoriasis.
2. Patients suffering from psoriasis with less than 50% of the body surface involvement.
3. Subjects with chronicity of disease more than 6 months and less than 5 yrs.
4. The patient who is fit for Basti Karma (Basti Yogya).
|
|
| ExclusionCriteria |
| Details |
1. Patient presenting with clinical features other than psoriasis like generalized skin
lesions, herpes simplex, herpes zooster, scabies, acne, urticaria and immunological
medicated skin diseases like pemphigus vulgaris, dermatitis herpetiformis, guttate
psoriasis, pustular psoriasis, lupus erythematous, psoriatic arthropathy etc.
2. Patient suffering from severe psoriasis with more than 50% of the body surface
involvement.
3. Patient with chronicity of disease less than 6 months and above 5 yrs.
4. Subjects of either sex age below 20 years and above 60 years.
5. Patient on medication like corticosteroids, phototherapy, biologics, antidepressant
and any other drugs that may have an influence on the outcome of the study .
6. Alcoholics or drug abusers.
7. Systemic Lupus Erythematous and other Auto Immune disorders.
8. Patients having systematic pathologies like cardiac diseases, renal diseases and
endocrine disorders.
9. Pregnant and lactating women.
10. Patient who are contra-indicated for Basti Karma (Basti Ayogya).
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relieve in the sign and symptoms of Psoriasis |
45th day after treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To improve quality of life of patient.
2. Remove the stress factor of Psoriasis patient.
|
At 15th, 30th, 45th day after treatment. |
|
|
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)
|
15/07/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 one of the most common dermatological diseases. It is a complex, chronic, multi-factorial, non-contagious inflammatory skin disease characterized by erythematous, sharply demarcated papules and rounded plaques, covered by silver shiny scale. Eka kushtha consists of sign and symptoms i.e. Aswedanam,Mahavastu and Matsya Shakalopam Avastha which can be compared with Psoriasis and hence it has been taken analogue to Psoriasis in present research work. In present study, Basti Chikitsa is selected because Acharya Sushrut described the indication of Basti in sansargaj and sannipataj vikara. Due to dominance of Tridosha in Kushtha and mainly Vata, Kapha in Eka Kushtha, favoured the treatment of Patola-Nimabadi Basti.The dravya of Patola-Nimbadi Basti is Tikta rasatmaka. Tikta dravya are Deepak, Pachak and Kaphaghna, Lekhan and Vishghana in nature and the effect on skin is Kandughna, Daha-Prashaman and Sthirikaran. Therefore, Patol-Nimbadi Basti is selected in management of Psoriasis Aim: Evaluation of Patola-Nimbadi Basti in management of Psoriasis (Eka Kushtha). Objective: To Evaluate Efficacy of Patola-Nimbadi Basti in management of Psoriasis (Eka Kushtha). Research Hypothesis (H1):- Patola-Nimbadi Basti is effective in the management of Psoriasis (Eka Kushtha). Null Hypothesis (H0):- Patola-Nimbadi Basti is not effective in the management of Psoriasis (Eka Kushtha). Study Plan: 30 patients will be selected of psoriasis on the basis of selection criteria. All patients will be given Patola-nimbadi Niruh basti and Goghrit Anuvasan basti as per the schedule of kala basti for 15 daya. Observations will be done on the basis of before and after subjective and objective parameters. Analysis will be done after 15 days of Basti treatment and at 30th and 45th day as follow up. |