A Clinical study to evaluate the effect of Tilwaka Kshara as topical application in 30 participants for removing Warts and Skin Tags

Phase 2

Not yet recruiting

Conditions: Local infection of the skin and subcutaneous tissue, unspecified. Ayurveda Condition: CARMAKILAH,

Registration Number: CTRI/2025/06/088256

Brief Summary: A SINGLE-ARM, OPEN-LABELLED CLINICAL STUDY TO EVALUATE THE EFFECT OF TILWAKA TEEKSHNA PRATISARANEEYA KSHARA IN THE MANAGEMENT OF CHARMAKEELA

Charmakeela is classified as one of the Kshudra rogas by Acharya Susrutha and Vagbhata. It occurs when vyana vata combines with kapha ,leading to the formation of hard , immobile ,peg-like growths on the skin’s surface , characterized by rough texture.

In Ayurveda, Charmakeela which bears a striking resemblance to warts and skin tags. The most well known cause of warts is infection with the human papillomavirus ( HPV ). Warts and skin tags represent one of the most prevalent dermatological issues globally.

The management of Charmakeela involves topical application of Kshara , Agni and Shastra.

The aim of this proposed study is to evaluate the effect of Tilwaka teekshna pratisaraneeya kshara in the management of Charmakeela. The study will be conducted as an single -arm ,open labelled clinical trial without control group with 30 participants between the ages of 18 and 60 years ,regardless of gender ,who meet the specified inclusion and exclusion criteria. These participants are selected from both OP and IP Department of Shalyatantra, Pankajakasthuri Ayurveda Medical College & PG Centre Hospital , Kattakada , Thiruvananthapuram.

The assessment of symptoms will primarily rely on clinical examinations. This study will examine the treatment of Charmakeela using topical application of Tilwaka teekshna Pratisaraneeya kshara. The procedure will involve single sitting. Assessments will be conducted before treatment ( 0th day), on 7th day and 14th day . Scar assessment will be done on 14th and 21st day. Follow up will be conducted on 21st day. Statistical analysis will be performed on the results obtained during the study to draw conclusions about the effectiveness of the treatment.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

1.Subjects with warts or skin tags on neck, upper limbs or lower limbs.
2.Subjects of age group 18 -60 years irrespective of gender, religion, occupation and socio- economic status.
3.Subjects who are willing to provide informed consent.

Exclusion Criteria

1.Skin lesions more than 5mm size.
2.Pigmented lesions, Neurofibroma, Genital warts and Plantar warts.
3.Subjects contraindicated for Pratisaraneeya ksharakarma.
4.Diagnosed with systemic conditions such as Tuberculosis, HIV, Diabetes mellitus, Hypertension, Bleeding Disorders and Carcinoma.
5.Warts displaying features suggestive of a carcinomatous appearance.
6.Subjects taking anti-coagulants.
7.Subjects with a history of allergy.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the effectiveness, safety, and clinical applicability of Tilwaka Teekshna	Assessment of size of lesion will be done before treatment (0th day), 7th day and 14th day after treatment. \| Scar assessment will be on 14th day and 21st day. \| Follow up assessment will be done on 21st day after treatment.
Pratisaraneeya Kshara as a topical application in the management of Charmakeela.	Assessment of size of lesion will be done before treatment (0th day), 7th day and 14th day after treatment. \| Scar assessment will be on 14th day and 21st day. \| Follow up assessment will be done on 21st day after treatment.
1.Number of days taken for complete shedding of the lesion	Assessment of size of lesion will be done before treatment (0th day), 7th day and 14th day after treatment. \| Scar assessment will be on 14th day and 21st day. \| Follow up assessment will be done on 21st day after treatment.
2.Reduction in size of the lesion (in mm)	Assessment of size of lesion will be done before treatment (0th day), 7th day and 14th day after treatment. \| Scar assessment will be on 14th day and 21st day. \| Follow up assessment will be done on 21st day after treatment.
3.Scar assessment after healing	Assessment of size of lesion will be done before treatment (0th day), 7th day and 14th day after treatment. \| Scar assessment will be on 14th day and 21st day. \| Follow up assessment will be done on 21st day after treatment.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (1): Pankajakasthuri Ayurveda Medical College and PG Centre
🇮🇳
Thiruvananthapuram, KERALA, India
Pankajakasthuri Ayurveda Medical College and PG Centre
🇮🇳Thiruvananthapuram, KERALA, India
Dr Priya K Yesudas
Principal investigator
8075262851
priyayesudas94@gmail.com