PROTEUS JOURNAL ISSN/eISSN: 0889-6348

COMPARATIVE, OPEN LABELLED CLINICAL STUDY TO EVALUATE EFFECT OF GOMAY TAILA AND PANCHAGAVYA GHRITA ON PADADARI

Dr. Kalyani P. Nishane1, Dr. G.H. Yeola2, Dr. Khyati B. Rohit3

1. P.G. Scholar, Department of Kayachikitsa, Dr. D. Y. Patil College of Ayurved and Research Centre, Pimpri, Pune of Dr. D. Y. Patil Vidyapeeth, Pune (Deemed to be University) ([email protected]) 2. Principal and HOD, Department of Kayachikitsa, Dr. D. Y. Patil College of Ayurved and Research Centre, Pimpri, Pune of Dr. D. Y. Patil Vidyapeeth, Pune (Deemed to be University) ([email protected]) 3. P.G. Scholar, Department of Kayachikitsa, Dr. D. Y. Patil College of Ayurved and Research Centre, Pimpri, Pune of Dr. D. Y. Patil Vidyapeeth, Pune (Deemed to be University) ([email protected])

*Corresponding Author,

Prof. Dr. G.H. Yeola,

Dr. D. Y. Patil College of Ayurved and Research Centre,

Pimpri, Pune, Dr. D. Y. Patil Vidyapeeth, Pune (Deemed to be University)

Maharashtra (India)

Pin – 411018

Mob: +91 9028321955

Email: [email protected]

VOLUME 11 ISSUE 9 2020 http://www.proteusresearch.org/ Page No: 514 PROTEUS JOURNAL ISSN/eISSN: 0889-6348

ABSTRACT –

In , Padadari Vyadhi is mentioned under the heading of Kshudra Roga (minor diseases of skin) by Acharya Sushruta, Madhavnidana, Bhavprakash, Yogaratnakara etc. It is mentioned that Padadari is caused due to Vataprakopaka Hetu, Atichankraman i.e. Excessive walking especially barefooted and Ruksha Guna. Sign and symptoms of Padadari are similar to crack heels. In the modern science, it is not considered as a disease entity but only as a symptom. Ayurveda has mentioned two types of treatment in Padadari – Antahparimarjan and Bahirparimarjan Chikitsa which mean internal medication and local therapy respectively. In Padadari, local treatment is as effective as internal medication. Comparative, open labelled clinical study has been conducted to evaluate effect of gomay taila and panchagavya ghrita on padadari. Methods- The Gomay taila and Panchagavya ghrita were prepared by traditional Taila and Ghrita kalpana respectively and then given to 60 patients of Padadari with 30 each, which were selected from out-patient department of Dr. D. Y. Patil Ayurveda Hospital and Research Center, Pimpri, Pune. It was given for external application twice a day on the site of Padadari for 14 days consecutively. Result- All assessment parameters were found to be statistically significant. Conclusion – The study revealed that the Gomay taila and Panchagavya ghrita extremely significant on distribution of dari with P<0.0001 and associated with kathinya, rukshata, saruja, kandu and daha the P value is <0.014 and <0.003 respectively.

KEY WORDS – Padadari, Crack heels, Gomay taila, Panchagavya ghrita.

VOLUME 11 ISSUE 9 2020 http://www.proteusresearch.org/ Page No: 515 PROTEUS JOURNAL ISSN/eISSN: 0889-6348

INTRODUCTION –

Healthy skin depicts the personality of an individual. Now days, skin disease are very common due to various causes like consumption of unhealthy food or lifestyle modification or environmental pollution or due to stress, skin problems are increasing day by day and it also affects the quality of life of an individual. The most common skin diseases are seen now days are crack feet, Acne, Alopecia etc.

परिक्रमणशीलय ्वायुित्तत्तयर्셁थ क्षयो: ।

पादयो: कु 셁ते दािी स셁जाम ्तलसंश्रिताम ्॥ 1 (सु.नि.१३/३०) It is mentioned that Padadari is caused due to Vataprakopaka hetu, atichankraman i.e. Excessive walking especially barefooted and ruksha guna. Padadari disease is mentioned by Acharya Sushruta, Madhav nidan, Bhavprakash under the heading of Kshudraroga. The word Kshudraroga is made up of two words i.e. kshudra and roga. Kshudra means alpa or short/ small/ minor and roga means diseases. So kshudraroga are small / short/ minor diseases. They are named kshudraroga because their nidan, lakshan and chikitsa are described in kshudra i.e. in short or brief. Kshudraroga comprises of a major part of the skin diseases.

Sign and symptoms of Padadari vyadhi are similar to crack feet mentioned in modern medicine. It is also called as Fissure. The distinct branch dealing with clinical features along with treatment called as Podiatry. Crack heel is a clinical condition having dry and itchy skin, roughness and hardness around the rim of the heel and cracks or fissures on outer edge of the heel. There is no any study have yet revealed that in which sex the Padadari is seen more or occur early. It can occur in any age group and at any stage of life.

Ayurvedic recommendation of the management of Padadari includes Siravedha (puncture of the veins) of the feet and treatment of the affected part which includes snehan and swedan. Many proven medicines have been already available in market for Padadari but here we have prepared Gomay taila and Panchagavya ghrita for local application on affected site for 14 days.

VOLUME 11 ISSUE 9 2020 http://www.proteusresearch.org/ Page No: 516 PROTEUS JOURNAL ISSN/eISSN: 0889-6348

Aim-

To evaluate the effect of Gomay taila and Panchagavya ghrita in Padadari (Cracked feet) through comparative clinical trial.

Objectives -

a) To study present day life style as a causative factor for Padadari. b) To study samprapti (pathogenesis) of Padadari. c) To study Padadari in detail from samhita granthas. d) To assess the result of Gomay taila and Panchagavya ghrita in Padadari.

Material and Methods –

60 patients of Padadari were selected within the age group of 20 - 70 years were selected randomly from OPD of Dr. D. Y. Patil Ayurveda college, Hospital & Research centre, Pimpri, Pune, irrespective of sex, occupation and socio-economic status.

Selection criteria –

Inclusion criteria –

a) Age groups between 20 to 70 years. Irrespective of sex, religion, socio-economic status, marital status, occupation was selected. b) Diagnosis was done on the basis of sign and symptoms of Padadari (dry, itchy skin, hardness around the rim of the heel and cracks or fissures on outer edge of the heel).

Exclusion criteria – a) Patient below the age of 20 and above 70 years.

b) Foot ulcer, diabetic foot ulcer and any other local dermal lesions.

c) Chronic illness and infection like TB, CA and HIV infection.

Parameters for study –

It’s a comparative clinical study were patients are divided into two groups of 30 each.

Group A – 30 patients of Padadari were treated with Gomay taila, 15 ml twice a day for external application over Padadari. Cleaning of sole before application of taila was advised.

VOLUME 11 ISSUE 9 2020 http://www.proteusresearch.org/ Page No: 517 PROTEUS JOURNAL ISSN/eISSN: 0889-6348

Group B – 30 patients of Padadari were treated with Panchagavya ghrita, 15 Gm twice a day for external application over Padadari. Cleaning of sole before application of ghrita was advised.

Criteria of assessment –

Assessment was done on subjective criteria before and after treatment. Photography was also taken. They are analysed on the basis of different scores such as severe: 3, moderate: 2, mild: 1 and nothing: 0.

Overall effect of therapy Steps for calculating the overall % of improvement of individual by the formula i) Percentage improvement in each patient of all symptoms was calculated by the formula: (B.T- A.T) x 100 B.T ii) Average of the percentage improvement was calculated.

Statistical analysis

The obtained data were analysed statistically using the Wilcoxon signed rank test and Mann- Whitney U test for the differences in score before and after the treatment in both the groups and the level of P <0.05 was considered Statistically significant.

Subjective criteria –

a) Distribution of dari b) Twakkathinya c) Ruksha d) Saruja e) Kandu f) Daha

Observation period – observations and recording of patient will be done just to the subjecting of patients to the treatment and then every 7th and 14th day follow up done. Thus, the total period of observation will be 14 days.

VOLUME 11 ISSUE 9 2020 http://www.proteusresearch.org/ Page No: 518 PROTEUS JOURNAL ISSN/eISSN: 0889-6348

Gradation Chart –

Sr. No. Signs 0 (No) 1 (Mild) 2 (Moderate) 3 (Severe) 1. Distribution of dari No any dari At heel Heel with whole Whole foot over feet border of feet 2. Twakkathinya No roughness Occasional/Mild Moderate Severe 3. Ruksha No any Occasional/Mild Moderate Severe dryness 4. Saruja No saruja Occasional/Mild Moderate Severe 5. Kandu No kandu Occasional/Mild Moderate Severe 6. Daha No daha Occasional/Mild Moderate Severe

Observation –

Gomay taila administered for first group, is statistically significant (P < 0.0001) on distribution of dari, Twak -kathinya, Ruksha, Saruja, Kandu and Daha (P < 0.014).

Table 1: Tests of Significance for Group 1

Group 1 BT AT SD P Value % Relief Distribution of 2.07 0.73 0.521 0.0001 30 %

dari

Twakkathinya 2.03 0.53 0.507 0.0001 46.7 % Ruksha 1.97 0.47 0.507 0.0001 53.3 % Saruja 1.40 0.20 0.484 0.0001 83.3 % 0.93 0.03 0.183 0.0001 96.67 % Kandu Daha 0.37 0.07 0.254 0.014 93.33 %

VOLUME 11 ISSUE 9 2020 http://www.proteusresearch.org/ Page No: 519 PROTEUS JOURNAL ISSN/eISSN: 0889-6348

Tests of Significance for Group 1 2.5 2.07 2.03 1.97

2

1.5 1.4

0.93 Before Treatment 1 Mean score Mean 0.73 After Treatment 0.53 0.47 0.5 0.37 0.2 0.03 0.07 0 DD TK Ruksha Saruja Kandu Daha Symptoms

Table 2: Tests of Significance for Group 2

Group 2 BT AT SD Wilcoxon signed P Value % Relief Ranks test value

Distribution 2.33 0.63 0.556 -5.007 0.0001 40 % of dari Twakkathinya 2.17 0.57 0.626 4.893 0.0001 50 % Ruksha 1.97 0.50 0.572 -4.849 0.0001 53.3 % Saruja 1.80 0.30 0.466 -4.833 0.0001 70% Kandu 0.90 0.03 0.183 -3.839 0.0001 96.33 % Daha 0.30 0.00 0.000 -3.000 0.003 100 %

Similarly, Panchagavya ghrita administred for second group is significant P <0.0001 for distribution of dari, twak kathinya, ruksha, saruja and kandu and for daha, the P value is < 0.003.

VOLUME 11 ISSUE 9 2020 http://www.proteusresearch.org/ Page No: 520 PROTEUS JOURNAL ISSN/eISSN: 0889-6348

Tests of Significance for Group 2 2.5 2.33 2.17 1.97

2 1.8

1.5 0.9 1 Before treatment 0.63 Mean score Mean 0.57 0.5 After treatment 0.5 0.3 0.3 0.03 0 0 DD TK Ruksha Saruja Kandu Daha Symptoms

Table 3 - Tests of significance for Group 1 and Group 2

Symptoms AT Mean SD Mann-Whitney P value U Test value Group 1 Group 2 Group 1 Group 2 Distribution 0.73 0.63 0.521 0.556 406.5 0.449 of dari Twak- 0.53 0.57 0.507 0.626 449.0 0.987 kathinya Ruksha 0.47 0.50 0.507 0.572 443.0 0.905 Saruja 0.20 0.30 0.088 0.085 393.5 0.264 Kandu 0.03 0.03 0.183 0.183 450.0 1.000 Daha 0.07 0.00 0.254 0.000 420.0 0.154

Comparison of efficacy of both drugs -

H0 = Null hypothesis – efficacy of Gomay taila = efficacy of Panchagavya ghrita

H1 = Alternative hypothesis - efficacy of Gomay taila is not equal to efficacy of Panchagavya ghrita.

VOLUME 11 ISSUE 9 2020 http://www.proteusresearch.org/ Page No: 521 PROTEUS JOURNAL ISSN/eISSN: 0889-6348

Since Mann-Whitney U Test value is statistically insignificant, the H0 i.e. Null hypothesis is accepted. And the alternate hypothesis is rejected. Hence both the trail drugs are somewhat equally effective in curing the Padadari and its symptoms.

Test Significance for group 1 and group 2

0.8 0.73

0.7 0.63 0.57 0.6 0.53 0.5 0.5 0.47

0.4 0.3 After treatment group 1

Mean score Mean 0.3 0.2 After treatment group 2 0.2 0.07 0.1 0.030.03 0 0 DD TK Ruksha Saruja Kandu Daha Symptoms

Discussion –

In Padadari, the main disease-causing agent is Vata dosha prakopa. In case of Padardari precise reference and explanation about its pathogenesis is not available in the classical texts of Ayurveda. Features of cracked feet like dry, hard, rough and thickened skin around the rim of the heel can be considered due to vitiated Vata Dosha leading to Padadri are seen after constantly having close contact of feet with water. Cold climate leads to exacerbations of symptoms of Padadari, conversely, hot and humid climate shows gradual relief of symptoms. As stated, Gomay taila and Panchagavya ghrita for local application is the main drug for this study.

Padadari is caused by Vataprakopaka hetu (e.g. Atichankramana). So, the disease Padadari can occur due to increased Ruksha, Laghu and Shita guna (esp. Ruksha) of Vata. So according to Samanya-Vishesha siddhanta of Chikitsa, for the Sampraptibhanga of Padadari drugs possessing greasy (snigdha), heavy to digest (), and hot (ushna) are required. Maximum contain of Gomay taila has tridoshahara property. And also, it is mentioned in Samhitas that gomay has vranaropak property. This all will help to reduce the ruksha guna present in padatala and vranaropaka property of Gomay taila will help to hill the cracks of feet. The base of Gomay taila is made up of tila taila. It has Madhura (Sweet),

VOLUME 11 ISSUE 9 2020 http://www.proteusresearch.org/ Page No: 522 PROTEUS JOURNAL ISSN/eISSN: 0889-6348

kashaya (astringent) Tikta (bitter) Rasa, Guru (heavy) Snigdha (greasy) Guna, Ushna Virya (hot potency), Madhura (sweet) vipaka, Tridhoshagna property, it is one of the best Vatahara Dravya. It helps to reduce Twak kathinya and Rukshata (dryness).

Also, the Panchagavya ghrita is made from the 5 contain obtained from Cow. This all 5 contain (Godugdha, Godadhi, Gomutra, Gomay, Goghruta possesses snigdha guna and hence help to reduce vitiated Vata dosha. The cow’s has ten properties viz, Sheeta (cold), Mrudu (soft), Snidgha (greasy), Picchila (cloudy), Guru (heavy), Manda (dull) and Madhura (sweet). It helps to reduce Twak kathinya and Rukshata (dryness). Gomutra has antiseptic property. Hence, it will also help to heel the cracks by killing the microbe’s present in-between the cracks. Goghruta also help to reduce Vata dosha by decreasing the ruksha guna and help to reduce dari and twak- kathinya by increasing the snigdha guna over Padatala.

Conclusion - On the basis of result of therapy, it can be concluded that both the group has excellent effect on Padadari. When we compare this two with each other, statistically and as per improvement in symptoms Panchagavya Ghrita has more significant effect as compare to Gomay taila. Females of age group between 41 to 50 years are more prone to Padadari. As study is of limited duration but if these drugs continued for longer duration, it will be more effective in Padadari. Financial support and sponsorship Self-financed Conflicts of interest There is no conflict of interest.

VOLUME 11 ISSUE 9 2020 http://www.proteusresearch.org/ Page No: 523 PROTEUS JOURNAL ISSN/eISSN: 0889-6348

Result –

Before Treatment After Treatment

BIBLIOGRAPHY

1. Bhisagratna KK, editor. Sushruta Samhita of Sushruta, Chikitsa Sthana. Vol.2. Ch.20, Ver.12 4th edition. Varanasi: Chaukhambha Sansthan; 1999. p.452 2. Yadunandan U, editor. Madhava Nidan of Madhavakar. Vol.2. Ch.55, Ver. 25. Reprint edition. Varanasi: Chaukhambha Prakashan; 2009. P.239 3. K.R. Srikantha Murthy, Dr. Anant Ram Sharma, Sushrut Samhita by Maharshi Sushruta, Sharir Sthana, Vol 1 Ch.13 ver.30, Chaukhamba Orientalia Varanasi, reprint 2000, P.558 4. Ediriweera ER, Peshala KK, Perera KM and Perera AM. A clinical study on effect of paste of Haritaki (Terminalia chebula Retz) in Padadari (Cracked Feet). J Ayurveda Holist Med 2014;2;2-5 5. Shashi Gupta, Rabinarayn Acharya. Management of Padadari (Cracked feet) with Rakta Snuhi (Euphorbia caducifolia Haines) based formulation: An open-labelled clinical study 6. Acharya Vidyadhar Shukla and Prof. Ravi Dutta Tripathi, Charaka Samhita by Agnivesha, Sharir Sthana Ch.7 ver.4, Chaukhamba Sanskrit Samsthana, P. 763. 7. Acharya Vidydhar Shukla and Prof. Ravi Dutta Tripathi, Charaka Samhita by Agnivesha, Sharir Sthana Ch.4 ver.11, Chaukhamba Sanskrit Samsthana, P. 728. 8. Dr. Anant Ram Sharma Sushrut Samhita by Maharshi Sushruta, Sharir Sthana, Ch.4 ver.4, Chaukhamba Publishing House, P.47

VOLUME 11 ISSUE 9 2020 http://www.proteusresearch.org/ Page No: 524 PROTEUS JOURNAL ISSN/eISSN: 0889-6348

9. Chandramouleeshwaran P, Govardhan K. Foot care through Ayurveda. Int J Res Ayurvada Pharm 2011; 2:1635-6 10. Sarojini B. A comparative clinical study on shalaniryasa and Madhuchishta in the management of Padadari. Int. Ayurvedic Med 2013; 1:1-7. 11. Mishra SN, editor. Abhinav Bhaishajya Kalpana Vijyana. Sneha Kalpana. Ch 5, Ver.1285. Reprint edition. Varanasi: Chaukhamba Surbharti Prakashan; 2007.p.222

VOLUME 11 ISSUE 9 2020 http://www.proteusresearch.org/ Page No: 525