E-ISSN:2456-3110

Research Article

Dermatitis

Journal of Ayurveda and Integrated Medical Sciences

2023 Volume 8 Number 11 November
Publisherwww.maharshicharaka.in

An open label single arm clinical study to evaluate the combined effectiveness of Navakashaya and Vidangadi Lepa in Vicharchika (Dermatitis)

Lawrence D1*, Girish K J2, Vasantha B3, Brata Tripathy T4
DOI:10.21760/jaims.8.11.2

1* Dija T Lawrence, Final Year Post Graduate Scholar, Department Of Kayachikitsa, Sri Dharmasthala Manjunatheswara College Of Ayurveda And Hospital, Hassan, Karnataka, India.

2 Girish K J, Professor, Department of Kayachikitsa, Patanjali Ayurveda College, Haridwar, Uttarakhand, India.

3 Vasantha B, Associate Professor, Department of Kayachikitsa, Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital, Hassan, Karnataka, India.

4 Tapas Brata Tripathy, Professor, Department of Kayachikitsa, Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital, Hassan, Karnataka, India.

Background: Vicharchika is one among the Kshudra Kushta with predominance of Kapha Dosha and it is characterized by, Kandu (Itching), Bahu Srava (Excessive exudation), Shyava Varna (Greyish black discolouration) and Pidaka (Papule). Vicharchika is similar to Dermatitis (Eczema). Dermatitis is a heterogenous group of disorders that share similarities in clinical appearance and histopathologic findings, but may have different etiologies. Objectives: To evaluate the combined effectiveness of Navakashaya and Vidangadi Lepa in the management of Vicharchika (Dermatitis). Methods: Among 34 registered subjects, 30 of them completed the course of treatment. They were administered with Navakashaya internally and Vidangadi Lepa application externally for a period of 30 days. Ordinal data was analyzed with Friedman’s test followed by Wilcoxon signed rank test as post-hoc and Nominal data was analyzed with Cochran Q test followed by McNemar test as post-hoc. Continuous data was analyzed by Repeated Measures ANOVA and after applying bonferroni correction with Paired t test as post-hoc. Results: There was statistically significant improvement in the subjective and objective parameters of Vicharchika (Dermatitis). Conclusion: Navakashaya and Vidangadi Lepa are effective in the management of Vicharchika (Dermatitis).

Keywords: Dermatitis, EASI Score, Navakashaya, Vicharchika, Vidangadi Lepa

Corresponding Author How to Cite this Article To Browse
Dija T Lawrence, Final Year Post Graduate Scholar, Department Of Kayachikitsa, Sri Dharmasthala Manjunatheswara College Of Ayurveda And Hospital, Hassan, Karnataka, India.
Email:
Lawrence D, Girish K J, Vasantha B, Brata Tripathy T, An open label single arm clinical study to evaluate the combined effectiveness of Navakashaya and Vidangadi Lepa in Vicharchika (Dermatitis). J Ayu Int Med Sci. 2023;8(11):8-16.
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https://jaims.in/jaims/article/view/2795

Manuscript Received Review Round 1 Review Round 2 Review Round 3 Accepted
2023-09-13 2023-09-23 2023-10-03 2023-10-13 2023-10-21
Conflict of Interest Funding Ethical Approval Plagiarism X-checker Note
None declared Nil Yes 18.99

© 2023by Lawrence D, Girish K J, Vasantha B, Brata Tripathy Tand Published by Maharshi Charaka Ayurveda Organization. This is an Open Access article licensed under a Creative Commons Attribution 4.0 International License https://creativecommons.org/licenses/by/4.0/ unported [CC BY 4.0].

Introduction

In Ayurveda, all skin disorders have been classified mainly into two groups - Mahakushta and Kshudra Kushta. Vicharchika is one among the Kshudra Kushta with the predominance of Kapha Dosha and it is characterized by the Lakshanas i.e., Kandu (itching), Bahu Srava (excessive exudation), Shyava Varna (blackish brown discolouration) and Pidaka (papule).[1]

On the basis of the symptoms, Vicharchika can be correlated with Dermatitis in modern science, which is a reaction pattern manifested by variable clinical and histologic findings. Dermatitis was estimated to affect 245 million people (3.34%) of the world population.[2] The prevalence of dermatitis is increasing because of rapid industrialization, use of chemicals, cosmetics, soaps and other irritants. About 10-20% of the general practice includes the patients suffering from skin disorders. Dermatitis accounts for a very large proportion of all the skin disease. Primary lesions may include papules, erythematous macules and vesicles which can coalesce to form patches and plaques. In severe dermatitis, secondary lesions such as weeping and crusting may predominate. Long-standing dermatitis is often dry and is characterized by thickened, scaling skin (lichenification). The histologic features of Dermatitis have been divided into three patterns: acute, sub-acute and chronic. Acute dermatitis shows a mixture of epidermal vesiculation, and a mononuclear cell infiltrate. Chronic dermatitis demonstrates epidermal acanthosis, hyperkeratosis, upper dermal fibrosis, and a predominantly perivascular mononuclear cell infiltrate. Mixtures of these two histologic reaction patterns occur in sub-acute dermatitis.[3]

In contemporary medical practice, antihistamines and topical steroids are the medications for Dermatitis. There is no specific description available in Samhita regarding the Chikitsasutra of Vicharchika. Hence the treatment is to be carried out according to the predominance of Dosha.

The Navakashaya[4] Yoga explained by Chakradutta in Kushta Adhikara comprises of Triphala, Patola, Rajani, Manjishta, Rohini, Vacha and Nimba. These drugs have properties like Tikta Rasa, Laghu and Ruksha Guna, Ushna Veerya, Katu Vipaka and Kapha Pittahara, Deepana and Varnya action.

External intervention i.e., Vidangadi Lepa[5] comprises of Vidanga, Saindhava, Shiva (Haritaki), Sasirekha (Bakuchi), Sarshapa, Karanja, Rajani ( Haridra), along with Go Jala (Gomutra Arka) which is explained by Chakradutta in Kushta Prakarana. These drugs have properties like Tikta Rasa, Laghu, Ruksha Guna, Ushna Veerya and Kushtagna. Hence both formulations are helpful in Samprapti Vighatana of Kapha Pradhana Vicharchika.

Objective

To assess the combined effectiveness of 45 ml of Navakashaya internally twice daily, before food with Anupana of warm water and Vidangadi Lepa application externally, once daily in day time with Gomutra Arka for a period of 30 days in the management of Vicharchika (Dermatitis).

Materials and Methods

Source of data: Patients who attended the out-patient department of Kayachikitsa at Sri Dharmasthala Manjunatheswara Ayurveda Hospital, Hassan.

Method of collection of data: Data was collected using specially prepared case report form.

Screening of the patient

A screening form was prepared with all aspects of history, signs, and symptoms of Vicharchika (Dermatitis).

Diagnostic criteria

Among screened patients, Vicharchika (Dermatitis) was diagnosed based on Lakshanas of Vicharchika (Dermatitis) such as Kandu (itching), Shyava Varna (Greyish black discolouration), Pidaka (papule), Bahu Srava (exudation).

Inclusion criteria

  • Subjects suffering with Vicharchika up to 1 year of chronicity
  • Subjects of either gender, aged between 18-70 years
  • Subjects willing to participate in the study and ready to sign informed consent form

Exclusion criteria

  • Subjects with uncontrolled diabetes mellitus
  • Pregnant and lactating women

  • Subjects with impaired cardiac, renal, and hepatic functions

Sampling technique - Convenient sampling

Sample size - 30

Statistical method

Ordinal data was analyzed with Friedman’s test followed by Wilcoxon signed rank test as post-hoc and Nominal data was analyzed with Cochran Q test followed by McNemar test as post-hoc. Continuous data was analyzed by Repeated Measures ANOVA and after applying bonferroni correction with Paired t test as post-hoc.

Ethical clearance and CTRI registration

The ethics clearance certificate from the Institutional Ethics Committee of Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan was obtained, with IEC No: SDM/IEC/75/2021 (9/7/2021). Trial was registered on Indian clinical trial registry, CTRI/2022/05/042516.

Study design

Open label single arm prospective clinical study with pre and post-test design, from outpatient department of a tertiary Ayurveda hospital attached to Ayurveda medical college located in district headquarters in Southern India.

Intervention

Internal medication

1. Navakashaya

Dose: 45ml twice daily (Morning and Evening), before food

Route of administration-Orally

Anupana - Warm water

Duration - 30 days

External Application

2. Vidangadi Lepa

Vidangadi Lepa Choorna application mixed with Gomutra Arka

Dose - Once daily, in day time (Morning - 15 minutes), Thickness of 3mm.

Duration - 30 days

Source and Authentication of Raw Drug

Required raw drugs for the medicine preparation were purchased from GMP certified Pharmacy - CKKM Ayurveda Medicine Manufactures, Kerala along with authentication certificate.

Assessment Criteria: 

Signs and symptoms of Vicharchika (Dermatitiis) like Kandu (itching), Shyava Varna (greyish black discolouration), Pidaka (papule), Bahu Srava (exudation) were assessed by giving suitable scoring at three intervals namely 1st, 15th and 30th day of treatment. The disease activity of the patient was assessed by Eczema Area and Severity Index Score (EASI Score).

Subjective parameter

  • Kandu

Objective parameter

  • Shyava Varna
  • Pidaka
  • Bahu Srava

Table 1: Scoring criteria of Kandu[6] (Pruritus)

GradeScore
Nearly no itching0
Mild or occasional itching (1-2 times in a day)1
Itching on and off2
Continuous itching without disturbance in routine3
Continuous itching with disturbance in routine even in sleep4

Table 2: Scoring criteria of Bahu Srava[6] (Discharge)

GradeScore
Nearly no weeping0
Moisture on the skin lesion1
Weeping from the skin after itching2
Weeping from the skin3
Profuse weeping making cloths wet4

Observations

Table 3: Demographic profile of 34 patients of Vicharchika

ObservationPredominancePercentage %
Age31-40 years11 (32.35%)
GenderFemale20 (58.82%)
Socio-economic statusLower middle17 (50%)

Table 4: Baseline distribution of Lakshanas of 34 patients of Vicharchika

Lakshana (Present)Percentage %
Kandu 34 (100 %)
Shyava Varna 34 (100 %)
Pidaka 34 (100 %)
 Bahu Srava 34 (100 %)

Results

MC Nemar Test

Table 5: Effect of Intervention on the assessment of Kandu between various intervals

BT - 15th Day
Kandu BTKandu 15thDayNPRemarks
PresentAbsent
Present26430>0.016NS
Absent00
15th Day - 30th Day
Kandu 15th DayKandu 30th DayNPRemarks
PresentAbsent
Present141230<0.016S
Absent04
BT - 30th Day
Kandu BTKandu 30th DayNPRemarks
PresentAbsent
Present1416 30 <0.016 S
Absent00

Wilcoxon signed Rank Test

Table 6: Effect of Intervention on scoring of Kandu

ParameterNegative RanksPositive RanksTiesTotalZ ValueP ValueRemarks
NMRSRNMRSR
BT - 15th Day189.50171.000.00.001230-3.866<0.016S
15th Day -30thDay2211.50253.000.00.00830-4.456<0.016S
BT - 30thDay2915.00435.000.00.00130-4.798<0.016S

MC Nemar Test

Table 7: Effect of Intervention on the assessment of Pidaka between various intervals

BT-15thDay
Pidaka BTPidaka 15thDayNPRemarks
PresentAbsent
Present291 30 >0.016 NS
Absent00
15th Day - 30th Day
Pidaka 15th DayPidaka 30th DayNPRemarks
PresentAbsent
Present22730<.016S
Absent01
BT - 30th Day
Pidaka BTPidaka 30thDayNPRemarks
PresentAbsent
Present228 30 <.016 S
Absent00

Cocharn Q Test

Table 8: Effect of Intervention on the assessment of Shyava Varna between various intervals

ParameterValueNCochran’s QP valueRemark
PresentAbsent
Shyava Varna BT300302.000P<0.05NS
Shyava Varna 15th Day300
Shyava Varna 30th Day291

MC Nemar Test

Table 9: Effect of Intervention on the assessment of Bahu Srava between various intervals

BT - 15th Day
Bahu Srava BTBahu Srava 15th DayNPRemarks
PresentAbsent
Present23730P<.016S
Absent00
15th Day - 30th Day
Bahu Srava 15th DayBahu Srava 30th DayNPRemarks
PresentAbsent
Present81530P<.016S
Absent07
BT - 30th Day
Bahu Srava BTBahu Srava 30th DayNPRemarks
PresentAbsent
Present82230P<.016S
Absent00

Table 10: Effect of Intervention on scoring of Bahu Srava

ParameterNegative RanksPositive RanksTiesTotalZ ValueP ValueRemarks
NMRSRNMRSR
BT - 15th Day158.00120.000.00.001530-3.624<0.016S
15th Day -30th Day2010.50210.000.00.001030-4.134<0.016S
BT - 30th Day2613.50351.000.00.00430-4.573<0.016S

Repeated measure ANOVA Test

Table 11: Effect of Intervention on EASI Score

Parameter (EASI)NMeanGreenhouse-GeisserGreenhouse-Geisser errorDfRemarks
dfF ValueP Value
 BT30 9.181.66212.443<0.0548.194S
15th Day7.68
 30th Day6.63

Table 12: Effect of Intervention on EASI Score - Pair wise

Gross ScoreIGross ScoreJMean difference(I-J)StdDeviationStd. errorMean t ValueSig.Remarks
BT15th Day1.4933.132.5712.611<.016S
15th Day30 th Day1.0562.085.3802.776<.016S
BT30 th Day2.5503.095.5654.512<.016S

Discussion

Effect on Kandu

Statistically significant improvement was found in Kandu after treatment. Mc Nemar test (P value< 0.016) showed improvements in counts at intervals of 15th day - 30th day (p.000) and BT - 30th day (p.000). Kandu was present in 26 subjects and was absent in 4 subjects at interval of BT - 15th day. From 15th day - 30th day interval of treatment Kandu


was absent in 12 subjects and from BT - 30th day interval of treatment Kandu was absent in 16 subjects. Navakashaya containing Patola, Rajani, Nimba and Vidangadi Lepa containing Sarshapa, Haridra and Gomutra have Kandughna property.

Tikta Rasa is Kaphahara and Rakthaprasadhana. Navakashaya and Vidangadi Lepa possess Tikta Rasa, Laghu Rooksha Guna and Ushna Veerya which are opposite to the Guru, Snigdha and Sheeta properties of Kapha Dosha, which is responsible for Kandu.

Effect on Pidaka

Statistically significant improvement was found in Pidaka after treatment. Mc Nemar test (P value <0.016) showed improvements in count at intervals of 15th day - 30th day (p.016) and BT - 30th day (p.008). Pidaka was present in 29 subjects and was absent in 1 subject at interval of BT - 15th day. From 15th day - 30th day interval of treatment Pidaka was absent in 7 subjects and from BT - 30th day interval of treatment Pidaka was absent in 8 subjects. The vitiated Pitta when accumulates in Twacha and Rakta, it causes Pidaka. Rakta is the Ashraya for Pitta Dosha. Tikta Rasa is Pittahara and Rakthaprasadhana. Navakashya containing Triphala, Rajani, Manjishta, Katuki Nimba and Vidangadi Lepa containing Haritaki, Bakuchi, Sarshapa, Karanja and Haridra are Pittahara.

Effect on Shyava Varna

Statistically significant improvement was not noticed in Shyavavarna after treatment. The Cochran Q Test and Post hoc test with MC Nemar test showed no improvements in mean ranks of three intervals i.e., BT-15th day, 15th day-30th day and BT-30th day. But clinically there was reduction in Shyava Varna.

Effect on Bahu Srava

Statistically significant improvement was found in Bahu Srava after treatment. Wilcoxon signed rank test (P value<0.016) showed improvements in mean ranks at intervals of BT-15th day (p.016), 15th day-30th day (p.000) and BT-30th day (p.000). Bahu Srava was present in 23 subjects and was absent in 7 subjects at interval of BT-15th day. From 15th day-30th day interval of treatment Bahu Srava was absent in 15 subjects and from BT-30th day interval of treatment Bahu Srava was absent in 22 subjects. Srava can be due to both Kapha and Pitta Dushti. Navakashaya

and Vidangadi Lepa containing ingredients are Tikta Rasapradhana, which is Pittahara and Kaphahara. Both formulations possess Rooksha Guna, which is opposite to the Snigdha Guna of Kapha and Pitta Dosha which is responsible for Bahu Srava.

Assessment score of Dermatitis (Vicharchika)

EASI Score on Head and Neck

Statistically significant improvement was not found in the erythema, papulation, Scratching and lichenification in head and neck after three intervals of treatment i.e., BT-15th day, 15th day-30th day and BT-30 th day. This may because of less number of subjects having involvement of head and neck region and because of less sample size lead to statistically not significant.

EASI Score on Trunk

Statistically significant improvement was not found in the erythema, papulation, Scratching and lichenification in head and neck after three intervals of treatment i.e., BT-15th day, 15th day-30th day and BT-30 th day. This may because of less number of subjects having involvement of head and neck region and because of less sample size lead to statistically not significant.

EASI Score on Upper limb

Statistically significant improvement was found in the erythema in upperlimb. Wilcoxon signed rank test (P value<0.016) showed improvements in mean ranks at intervals of BT-30th day (p.005). Statistically significant improvement was found in the papulation in upperlimb. Wilcoxon signed rank test (P value<0.016) showed improvements in mean ranks at intervals of BT-15th day (p.014), and BT-30th day (p.005). Statistically significant improvement was found in the scratching in upperlimb. Wilcoxon signed rank test (P value<0.016) showed improvements in mean ranks at intervals of BT-30th day (p.008). Statistically significant improvement was found in the lichenification in upperlimb. Wilcoxon signed rank test (P value<0.016) showed improvements in mean ranks at intervals of BT-30th day (p.008). This may because of majority number of subjects having involvement of upper limb region.

EASI Score on Lower limb

Statistically significant improvement was found


in the erythema in lowerlimb. Wilcoxon signed rank test (P value<0.016) showed improvements in mean ranks at intervals of BT-15th day (p.014) and 15thday-30thday (p.008) and BT-30th day (p.000). Statistically significant improvement was found in the papulation in lowerlimb. Wilcoxon signed rank test (P value<0.016) showed improvements in mean ranks at intervals of BT-15th day (p.014), 15thday-30thday (p.002) and BT-30thday (p.000). Statistically significant improvement was found in the scratching in lowerlimb. Wilcoxon signed rank test (P value<0.016) showed improvements in mean ranks at intervals of BT-30th day (p.008). Statistically significant improvement was found in the lichenification in lowerlimb. Wilcoxon signed rank test (P value<0.016) showed improvements in mean ranks at intervals of 15thday-30thday (p.005) and BT-30th day (p.001). This may because of majority number of subjects having involvement of lower limb region.

EASI Score

Statistically significant improvement was found in mean score of EASI Score in BT-15th Day with mean difference (1.493, p.014, SD 3.132) 15th Day- 30thDay with mean difference (1.056, p.010, SD 2.085) and BT- 30th Day with mean difference (2.55, p.000, SD 3.095). Overall, the combination of Navakashaya and Vidangadi Lepa were found to show statistically significant result in relieving symptoms like erythema, papulation, excoriation and lichenification.

Discussion on Probable mode of action of drug

This study was intended to evaluate the combined effectiveness of Navakashaya internally and Vidangadi Lepa externally in Kushta Chikitsa. The ingredients of Navakashaya and Vidangadi Lepa possess Tikta Rasa, Laghu Rooksha Guna, Ushna Veerya, Katu Vipaka and Kushtagna properties which are opposite to the qualities of Kapha.

The administration of Haritaki extract helps in decreasing keratinization, mast cell infiltration and inflammation related mediators.[7] Amalaki helps in liver detoxification and it is rich in Vitamin C. It is good for the complexion (Varnya). The paste obtained from Vibhitaki offers distinctive advantages in wound healing.[8]

Patola possess anti-inflammatory and wound healing activity. Haridra is also called by the

name of Vishothajita, which means it can act as an anti-inflammatory and help in decreasing the erythema of the skin. It improves the complexion and might have helped in the Vaivarnya of skin. Manjishta root extract has been used as anti-inflammatory agent because of the presence of rubimallin. It inhibits the lipoxygense enzyme pathway, which catalyze the production of various inflammatory mediators such as leukotriens.[9] Nimba (Azadirachta indica) has a complex of various constituents including nimbin, nimbidin, nimbolide, and limonoids and such types of ingredients play role in diseases management through modulation of various genetic pathways and other activities.[10] Alcoholic extract of Katuki and compounds kutkin, picroside-1 and kutkoside have been reported for their anti-inflammatory and antioxidant activity.[11] Vacha leave extract has, characteristics of restriction of interleukin. Bakuchi is Katu Tikta in Rasa, Laghu, Ruksha in Guna, Ushna Veerya and has Katu Vipaka. It helps in balancing Vata and Kapha. It is Kushtaghna, Deepana, Pachana, Anulomana, and Vranashodhana by Karma. Karanja has Katu, Tikta, Kashaya Rasa, Laghu Teekshna Guna and Ushna Veerya and acts as Kapha and Vata Shamaka. It is Kushtaghna, Shothahara, and known as Kushtajita which means helpful in treating all types of skin disorders. Ethanol leaf extract and embelin isolated from Vidanga were proved good for wound healing in albino rats. Sarshapa balances Vata and Kapha Dosha.[12] Gomutra Arka is Kushtashamaka, Kanduhara, Kaphahara and useful in Alepana. Gomutra Arka is Kushtahara and Kanduhara. Hence, it can be concluded that Navakashaya and Vidangadi Lepa were effective in the management of Vicharchika (Dermatitis).

Mechanism of action of Lepa

Network of Sira, underneath the skin and their openings are attached to hair follicles which carry sweat and replenish Rasa inside and outside through the Veerya of Lepa. Dravyas enter the body after being transformed in skin. Because of application of Lepa, the skin temperature increases which helps in hastening the pilosebaceous uptake and skin permeation of the drug in topical formulation. Though small amounts of chemicals may enter the body rapidly through the glands or hair follicles, they are primarily absorbed through the epidermis. Chemicals must pass through the


cell layers of epidermis before entering the dermis where they can enter the blood stream and circulate to other areas of body. The stratum corneum is the outermost layer of the epidermis and the rate limiting barrier in absorption of an agent. After penetrating through the stratum corneum and into viable epidermis and dermis the molecules of the formulation produce its characteristic pharmacological response through receptors even before the blood and lymph circulations remove it. Thus, Lepa helps to remove the toxins.[13]

Conclusion

45 ml of Navakashaya internally twice daily, before food and Vidangadi Lepa application externally, once daily in day time with Gomutra Arka for a period of 30 days was effective in the management of Vicharchika (Dermatitis). It showed significant improvement in symptoms such as Kandu, Pidaka and Bahusrava. There was no significant improvement in Shyava Varna. There was a significant improvement in the EASI score. Thus, Research hypothesis was accepted.

References

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