CTRI

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CTRI Number

CTRI/2021/03/032363 [Registered on: 26/03/2021] Trial Registered Prospectively

Last Modified On:

05/03/2021

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Ayurveda

Study Design

Randomized, Parallel Group Trial

Public Title of Study

Role of Ayurvedic medicine in the Management of Psoriasis (skin disease).

Scientific Title of Study

A Randomised Comparative Clinical Study to Evaluate the Efficacy of Kushthadalan Ras, Darvyadi Kwath and Somraji Taila in the Management of Sidhma Kushtha with special reference to Psoriasis Vulgaris.

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Preeti Sahu
Designation	PG Scholar
Affiliation	National Institute of Ayurveda (Deemed to be university)
Address	P.G. Dept. of Kayachikitsa National Institute of Ayurveda Jaipur Jaipur Rajasthan Jaipur RAJASTHAN 302002 India
Phone	9636922840
Fax
Email	preetirobinson72@gmail.com

Details of Contact Person
Scientific Query

Name	Dr H M L Meena
Designation	Associate Professor
Affiliation	National Institute of Ayurveda(Deemed to be university)
Address	P.G. Dept. of Kayachikitsa National Institute of Ayurveda Jaipur Jaipur Rajasthan Jaipur RAJASTHAN 302002 India
Phone	9785297017
Fax
Email	hari_mohan68@yahoo.co.in

Details of Contact Person
Public Query

Name	Dr Rashmi Mutha
Designation	Lecturer
Affiliation	National Institute of Ayurveda(Deemed to be university)
Address	P.G. Dept. of Kayachikitsa National Institute of Ayurveda Jaipur Jaipur Rajasthan Jaipur RAJASTHAN 302002 India
Phone	7976512056
Fax
Email	rashmimutha21@yahoo.com

Source of Monetary or Material Support

National Institute of Ayurveda Madhav Vilas Palace Amer Road Jaipur Rajasthan

Primary Sponsor

Name	National Institute of Ayurveda Jaipur
Address	Madhav Vilas Palace Amer Road Jaipur 302002
Type of Sponsor	Research institution and hospital

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Preeti Sahu	National Institute of Ayurveda Hospital Jaipur	OPD No 1, 7, 18, 22,25 Dept. of Kayachikitsa, Madhav Vilas Palace Amer Road Jaipur, 302002 Jaipur Rajasthan Jaipur Rajasthan Jaipur RAJASTHAN	9636922840 preetirobinson72@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

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:L400\|\|Psoriasis vulgaris. Ayurveda Condition: SIDHMAH,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	1.Darvyadi Kwath, and 2.Somraji Taila	15 Clinically diagnosed and registered patients of Sidhma Kushtha (Psoriasis Vulgaris) will be administered 1.Darvyadi Kwath, and 2.Somraji Taila Mode of Administration: Dose: 1.Kwath- 40 ml BD empty stomach, 2. oil- as per lesion BD, Dose Form: 1.Kwath, 2.Oil Route of Administration: Kwath orally, oil for local application Duration of therapy: 60 days
Intervention	1.Kushthadalan Ras, and 2.Somraji Taila.	15 Clinically diagnosed and registered patients of Sidhma Kushtha (Psoriasis Vulgaris) will be administered 1.Kushthadalan Ras, and 2.Somraji Taila. Mode of Administration: Dose: 1.Vati-250 mg BD empty stomach, 2. oil- as per lesion BD Dose Form: 1.Vati, 2.Oil Route of Administration: Vati orally, oil for local application Duration of therapy: 60 days

Inclusion Criteria

Age From	18.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	1. Patients having chronicity of Psoriasis less then 5 years duration. 2. Patient having any clinical signs and symptoms of Sidhma Kushtha as per Ayurvedic classics and Psoriasis as per modern classics. 2.1. Sveta tamra varna (white coppary in colour) 2.2. Tanu ( thin) 2.3. Alabupushpavarnam [resembles the flower of alabu (Lagenaria siceraria) discoloration] 2.4. Ghrustam vimunchati (scaling) 2.5. Rukshta (dryness) 2.6. Kandu (itching) 2.7. PASI Score 3. Patient willing to give consent for clinical trial.

ExclusionCriteria

Details

1. Patients on long term steroid and cytotoxic drugs.
2. Patients having illness like uncontrolled HTN,DM-II and Cardiac and Renal disorders, malignant diseases, major liver disorders, immunocompromised hosts etc.
3. Pregnant and lactating women.
4. Patients having complications of psoriasis like psoriasis arthropathy.

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 the PASI SCORE	60 DAYS

Secondary Outcome

Outcome	TimePoints
â€¢Changes in Subjective parameters 1.Kandu (Itching index) 2. Rukshata (Dryness) 3.Utsedh (Elevation of lesion) 4.Rajahghristam (scaling) 5.Daha (burning)	60 DAYS

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

Date of First Enrollment (India)

01/05/2021

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

NIL

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

Disease reference:- Sidhma Kushtha mentioned in Charak Samhita Nidana (5/6) and Chikitsa sthan (7/19)

In Sushrut Samhita Nidana Sthana (5/12)

In Ashtang Hridaya Nidana Sthana (14/22)

Drug reference :- 1. Kushthadalan Ras: Raskamdhenu 41/330

2.Somraji Taila: Chakradatta Kushthachikitsa 163,164,165

3.Darvyadi Kwath: Astang Hridaya Chikitsa Sthan-Kushthachikitsa 19/37

Need of Study: -

1. The worldwide burden of Psoriasis is 2%, and the prevalence of Psoriasis in India ranges from 0.44% to 2.8%.

2. Now a days Psoriasis became a most common type of skin disease. The modern stressful lifestyles, lack of adequate physical activities, and associated risk of metabolic syndrome. A lots of research work has already been done in but still a promising cure for Psoriasis is not found.

3. Modern medicine treats Psoriasis with PUVA, Topical and Systemic corticosteroids and anti mitotic drugs which give serious side effects like bone marrow depletion, liver toxicity, and also having recurrence of disease.

4. Ayurveda has a great potential in the management of Psoriasis and its associated complications.

5. Since every person is not suitable for Shodhana chikitsa , so in present study focusing on Shaman chikitsa for Sidhma Kushtha.

6. Since Kushtha is a Tridoshaja Vyadhi, it also a rakta pradoshaja vikara, and Sidhma Kushtha is a Vata Kapha dominant disorder. So Kushthadalan Ras, Darvyadi Kwath and Somraji Taila may be effective in the Shaman of vata , kapha as well as rakta dosha of Sidhma Kushtha (Psoriasis Vulgaris ).

Hypothesis:

Null Hypothesis H_o:

There is no difference between the efficacy of Kushthadalan Ras & Somraji Taila and Darvyadi Kwath & Somraji Taila in the management of Sidhma Kushtha W.S.R. to Psoriasis Vulgaris.

Follow up: After 15 days, 30^th day, 45^th day, and after completion of trial.