A Randomized Controlled Trial on the Efficacy of “SukhamPada” – A Herbal Heel Stick in the management of Padadari (Cracked Heels)

Title

A Randomized Controlled Trial on the Efficacy of “SukhamPada” – A Herbal Heel Stick in the Management of Padadari (Cracked Heels)

|PG Scholar

Dr. Rashika Poojary

|Guide

Dr. Mangala Wange (HOD & Professor)

|Study site

D.Y. Patil Deemed to be University, School of Ayurveda,

Nerul, Navi Mumbai-400706.

|Study Design

Double arm, Open labelled, standard control, randomized, prospective clinical study.

|Study duration

30 days

|Aim

To evaluate the clinical efficacy of “SukhamPada” - a classical herbal heel stick in the management of Padadari (cracked heels) in comparison with Truewise foot cream roll on.

|Objectives

1.     To evaluate the effectiveness of a classical herbal heel stick in relieving symptoms of Padadari (cracked heels).

2.     To compare the therapeutic outcome of the classical herbal stick with a standard control treatment in patients with Padadari.

3. To assess dryness and improvement in skin texture in the affected heel area.
4. To develop a stable, safe and effective topical formulation based on classical reference with modern application.

  |Population to be studied

Subjects of those having Padadari symptoms will be screened from Swasthavritta OPD and screening camps conducted by D Y Patil School of Ayurveda, Nerul, Navi Mumbai.

  |Sample size

GROUP A -35 participants (considering 20% dropout rate)

GROUP B -35 participants (considering 20% dropout rate)

  |Inclusion criteria

     1.     Both male and female

2.     Aged 18 years - 60 years

3.     Patients having with mild to moderate symptoms such as heel cracks, pain, roughness, dryness, itching.

4.     Patients having more than two symptoms.

5.     Participants willing to give written informed consent.

6.     Participants willing to follow up.

|Exclusion criteria

1.     Participants not willing to participate in study

2.     Patients with history of allergy, Infected, bleeding, or diabetic wounds or any infection intervening the condition.

3.     Patients having any severe systemic diseases like Renal, Hepatic,       Cardiac Disorders.

  |Efficacy parameters

1. Photographing
2. Padadari signs and symptoms grade using VAS
3. Padasputana (Number of cracks)
4. Peeling and cracked skin with crack size (in length)
5. Average width of cracks
6. Quality of Life Questionnaire

|Safety parameters

Adverse events recording

|Efficacy & Safety parameters Assessment Schedule

1. Photographing -V1 and V5
2. Padadari signs and symptoms grade using VAS- V1, V2, V3, V4,V5
3. Padasputana (Number of cracks)- V1, V2, V3, V4,V5
4. Peeling and cracked skin with crack size (in length) -V1, V2, V3, V4,V5
5. Average width of cracks- V1, V2, V3, V4,V5

6.     Physical examination will be done on V1, V2, V3, V4,V5

7.     Prakruti assessment scale- V1

8.     Quality of Life Questionnaire V1 and V5

9.     Questionnaire after completion of treatment-V5

|Statistical Analysis

Inter-Group Comparison: Mann-Whitney U test (for non-parametric data), Unpaired t test (parametric data)

 

S.NO.

GROUPS

GROUP A

GROUP B

|1.

PRODUCT

“SukhamPada” heel stick

Truewise foot cream roll on

|2.

ROUTE

Topical

Topical

|3.

DOSAGE

Apply a thin layer of “SukhamPada” stick over the cleaned and dry affected foot area.

 Apply a thin layer to affected foot area after cleansing.

  |4.

TIME OF ADMINISTRATION

Evening (before going to bed and leave it overnight)

Evening (before going to bed and leave it overnight)

|5.

DURATION

30 days

30 days

|6.

NO. OF PARTICIPANTS

30

30

|7.

VISITS/FOLLOW UP

7th day,

14th day,

21st day,

30th day,

7th day,

14th day,

21st day,

30th day,