| CTRI Number |
CTRI/2025/03/083338 [Registered on: 25/03/2025] Trial Registered Prospectively |
| Last Modified On: |
19/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Emesis and Nasal therapy in chronic plaque psoriasis |
|
Scientific Title of Study
|
A Randomized Comparative Controlled Clinical Study On Efficacy of Vaman And Nasya Karma In The Management Of Mandal Kushtha With Special Reference To Chronic 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. Satyanarayan Pal |
| Designation |
MD Scholar |
| Affiliation |
National institute of Ayurveda |
| Address |
ROOM NO 116,Panchakarma Department , National institute of Ayurveda, Jorawar singh gate , Amer road ,Madhav vilas Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
8455886450 |
| Fax |
|
| Email |
kunapal4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sarvesh Kumar Singh |
| Designation |
Associate Professor |
| Affiliation |
National institute of Ayurveda |
| Address |
ROOM NO 116,Panchakarma Department , National institute of Ayurveda, Jorawar singh gate , Amer road ,Madhav vilas Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
8739860237 |
| Fax |
|
| Email |
sarveshksingh21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sarvesh Kumar Singh |
| Designation |
Associate Professor |
| Affiliation |
National institute of Ayurveda |
| Address |
ROOM NO 116,Panchakarma Department , National institute of Ayurveda, Jorawar singh gate , Amer road ,Madhav vilas Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
8739860237 |
| Fax |
|
| Email |
sarveshksingh21@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute Of Ayurveda, Deemed to be University, Jaipur |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda |
| Address |
Madhav vilas palace, Jorawar singh Gate, Amer road , Jaipur |
| 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 Sarvesh Kumar Singh |
National Institute of Ayurveda |
Room no 116, Panchakarma department, Madhav Vilas Palace, Jorawar singh Gate,Amer road, Jaipur
Jaipur
RAJASTHAN |
8739860237
sarveshksingh21@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:L408||Other psoriasis. Ayurveda Condition: MANDALAKUSHTHAH/KAPAJAKUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: Astanga Hrdayam of Vagbhata vidyotini hindi commentary, Kaviraja Atrideva Gupta,sutra sthana;20:2 shloka, Procedure details: Purvakarma :-
1.Mridu Abhyanga on forehead, face, and neck.
2.Mridu Swendana on forehead, face, and neck.
Pradhankarma:-
1.Patients lie down on Nasya’s table in a supine position with an extended Neck.
2.Lukewarm Twagadi taila will be instilled into one nostril while another nostril kept close. The same process will be performed for another Nostril.
Dose of Twagadi taila: 6 Bindu in each nostril
Paschatkarma:-
1.Sthanik Swedana on forehead, face, neck
2.Mardan on palm, sole, shoulder, ear
3.Followed by Dhoompan
)
(1) Medicine Name: Twagadi taila, Reference: Charaka Samhita vidyotni teeka pt. Kashinath pandey, Dr.Gorakhnath Chaturvedi, chikitsa sthana;26;184-185 sholka, Route: Nasal, Dosage Form: Taila, Dose: 0.6(ml), Frequency: od, Duration: 21 Days | | 2 | Comparator Arm | Procedure | - | vamana-karma/ pracCardanam, वमन-कर्म/ प्रच्छर्दनम् | (Procedure Reference: Charaka Samhita vidyotni teeka pt. Kashinath pandey , Dr.Gorakhnath Chaturvedi, chikitsa sthana ;7:31 shloka, Procedure details: 1.Snehpana with Goghrta 7 days
2.Sarvanga abhyanga, (with Dashmoola oil) Sarvanga vashpa swedana (with Dashmoola kwath vashpa)- 2 days
3.Vamana karma – induced by administrating Vamaka yoga. (Madan Phala pippali yoga)
4. Dhoompan (dashamoola dhooma varti)
5. Samsarjan Krama – 7 days
one time in 23 days)
(1) Medicine Name: Madanaphala pippali, Reference: Charaka Samhita vidyotni teeka pt. Kashinath pandey, Dr.Gorakhnath Chaturvedi, kalpa sthana ;1/14 , Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 10(g), Frequency: od, Duration: 1 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
(a) Patient with the classical feature of Mandal kustha (plaque psoriasis)
(b) Patient not taking any other medication for Mandal kustha (plaque psoriasis)
(c) Patient fit for Vaman and Nasya Karma
(d) Patient willing to sign consent form for trial
(e) The participant with combined PASI score more than 5 to less than 72 will be included (moderate to severe form)
|
|
| ExclusionCriteria |
| Details |
(a) Age below the age 18 years & above the age 60 years
(b) Patients suffering from systemic disorders as cardiac problem, uncontrolled Diabetes mellitus, uncontrolled Hypertension, paralysis, malignancy, HIV, HBsAg, Leprosy
(c) Patient suffering from Psoriatic Arthritis
(d) pregnant and lactating mothers.
(e) patient unfit for Vamana and Nasya 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 (psoriasis area and severity index) |
Baseline, 14th day, and 28th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
(a) changes in DLOI (The Dermatology Life Quality Index)
(b) compliance of both the procedure Vamana & Nasya
|
Baseline, 14th day, & 28th day |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/08/2025 |
| 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="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
|
To study the comparative efficacy of Vamana and Nasya karma in the management of Mandal Kustha (Psoriasis), the study will include two groups: a comparator group and an intervention group. in the comparator group, the Vamana procedure with Madanphala Pippali( approximately 10 grams) in Kasaya form will be administered to patients. In the intervention group, Nasya procedure will be performed using Twagadi Taila (0.3 ml in each nostril) for seven consecutive days, with a gap of one day between sessions, repeated three times over a period of 23 days. Changes in PASI Score (psoriasis arear and severity index) and changes in DLQI ( The Dermatology Life Quality Index) along with Compliance of both the procedure Vamana and Nasya in patient will be assessed.
|