CTRI

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CTRI Number

CTRI/2026/02/104399 [Registered on: 20/02/2026] Trial Registered Prospectively

Last Modified On:

19/02/2026

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Ayurveda

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

A Clinical Study to Compare Two Ayurvedic Medicines with External Application in the Management of Plaque Psoriasis

Scientific Title of Study

A randomized double arm comparative clinical study to evaluate the efficacy of Ekavimshatika guggulu and Panchatikta ghrita guggulu along with Kasamarda lepa in kitibha kushta vis-a- vis 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 Anusha M Janna
Designation	PG Research Scholar
Affiliation	Hubli Ayurveda Seva Samitis Ayurveda Mahavidyalaya and hospital Heggeri Extension Hubli 580024
Address	Department of Kayachikitsa Hubli Ayurveda Seva Samitis Ayurveda Mahavidyalaya and hospital Heggeri Extension Hubli Dharwad KARNATAKA 580024 India
Phone	9113292035
Fax
Email	jannaanusha@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Poornima B
Designation	Professor
Affiliation	Hubli Ayurveda Seva Samitis Ayurveda Mahavidyalaya and hospital Heggeri Extension Hubli 580024
Address	Department of Kayachikitsa Hubli Ayurveda Seva Samitis Ayurveda Mahavidyalaya and hospital Heggeri Extension Hubli Dharwad KARNATAKA 580024 India
Phone	9986308966
Fax
Email	poornimabheemanna1@gmail.com

Details of Contact Person
Public Query

Name	Dr Anusha M Janna
Designation	PG Research Scholar
Affiliation	Hubli Ayurveda Seva Samitis Ayurveda Mahavidyalaya and hospital Heggeri Extension Hubli 580024
Address	Department of Kayachikitsa Hubli Ayurveda Seva Samitis Ayurveda Mahavidyalaya and hospital Heggeri Extension Hubli Dharwad KARNATAKA 580024 India
Phone	9113292035
Fax
Email	jannaanusha@gmail.com

Source of Monetary or Material Support

NIL

Primary Sponsor

Name	Dr Anusha M Janna
Address	Hubli Ayurveda Seva Samitis Ayurveda Mahavidyalaya and hospital Heggeri Extension Hubli 580024
Type of Sponsor	Other [SELF]

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 Anusha M Janna	Hubli Ayurveda Seva Samitis Ayurveda Mahavidyalaya and hospital Heggeri Extension Hubli 580024	Department of Kayachikitsa Hubli Ayurveda Seva Samitis Ayurveda Mahavidyalaya and hospital Heggeri Extension Hubli 580024 Dharwad KARNATAKA	9113292035 jannaanusha@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Ayurveda Mahavidyalaya and hospital Ethical Committe	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: KITIBAH,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Procedure	-	Alepa-karma, आलेप-कर्म	(Procedure Reference: Sharangadara Samhita, Procedure details: Kasamarda moola is made into churna (Powder) form and later mixed with Kanji (sour gruel) to prepare paste then it is applied over the lesions. Lepa is removed soon after drying from the skin.))) (1) Medicine Name: Kasamarda , Reference: Chakradatta Samhita, Route: Topical, Dosage Form: Lepa Churna, Dose: 10(g), Frequency: od, Duration: 30 Days
2	Intervention Arm	Drug	Classical		(1) Medicine Name: Guduchi Churna, Reference: Bhavaprakasha Nigantu, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Days, anupAna/sahapAna: Yes(details: Sukoshna Jala), Additional Information: -
3	Intervention Arm	Drug	Classical		(1) Medicine Name: Ekavimshatika Guggulu, Reference: Yogaratnakara Samhita, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Sukoshna Jala), Additional Information: -
4	Comparator Arm	Drug	Classical		(1) Medicine Name: Panchitatikta Grita Guggulu, Reference: Chakradatta Samhita, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Sukoshna Jala), Additional Information: -

Inclusion Criteria

Age From	16.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	Subjects of Kitibha Kushta Plaque Psoriasis on the basis of signs and symptoms like Shyava Kinakhara Sparsha Ugra Kandu Parusha Subjects of either sex between age group of 16 to 60 years Subjects of Kitibha Kushta Plaque Psoriasis with chronicity of 01 year.

ExclusionCriteria

Details

Subjects with Uncontrolled Diabetes Mellitus and Hypertension
Subjects with Other types of Psoriasis
Subjects suffering from HIV HBsAg and other Systemic disorders
Pregnant Lady and Lactating Mother
• Subjects of Kitibha Kushta (Plaque Psoriasis) with chronicity more than 1 year.

Method of Generating Random Sequence

Coin toss, Lottery, toss of dice, shuffling cards etc

Method of Concealment

An Open list of random numbers

Blinding/Masking

Participant Blinded

Primary Outcome

Outcome	TimePoints
To know the reduction in the PASI Score and reduction in Auspitz sign and candle grease sign.	30 days

Secondary Outcome

Outcome	TimePoints
To know the reduction in the Classical signs and symptoms of Kitibha Kushta ( Plaque Psoriasis ) like Kandu, Shyavata, Kinakara sparsha, Parushata.	30 days

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 4

Date of First Enrollment (India)

02/03/2026

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="6"
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

Skin diseases significantly affect quality of life with psoriasis being one of the most common chronic inflammatory skin disorders worldwide. In Ayurveda Kitibha Kushta a type of Kshudra Kushta closely resembles Plaque Psoriasis in its clinical presentation characterized by dryness roughness discoloration and intense itching with predominance of Vata and Kapha dosha along with Ama involvement.

Conventional treatments for psoriasis often provide symptomatic relief but are associated with adverse effects and frequent recurrences creating a need for safer and effective alternative therapies. Ayurveda offers a holistic approach through Deepana Pachana Shodhana and Shamana therapies along with external applications.

This study is a randomized double arm comparative clinical trial designed to evaluate and compare the efficacy of Ekavimshatika Guggulu and Panchatiktaghrita Guggulu both administered internally along with Kasamarda Lepa applied externally in the management of Kitibha Kushta Plaque Psoriasis. A total of 40 patients will be randomly divided into two groups and treated for 30 days with follow up up to 30 days.

Assessment will be carried out using subjective parameters objective clinical signs and PASI score supported by laboratory investigations. The study aims to establish the efficacy safety and comparative effectiveness of these Ayurvedic formulations in managing plaque psoriasis and to provide scientific evidence for their clinical utility.