Journal of Ayurveda and Integrated Medical Sciences

2025 Volume 10 Number 2 FEBRUARY
Publisherwww.maharshicharaka.in

An Open Label Single Arm Clinical Study to Evaluate the Combined Effectiveness of Oral Administration of Abhayarishta Churna and Aragwadha Patra Lepa in Kitibha Kushta (Psoriasis)

Hadapad HM1*, Jadhav LL2, Tripathy TB3
DOI:10.21760/jaims.10.2.4

1* Harish M Hadapad, Post Graduate Scholar, Department of PG Studies in Kayachikitsa, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan, Karnataka, India.

2 Lakshmiprasad L Jadhav, Professor, Department of PG Studies in Kayachikitsa, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan, Karnataka, India.

3 Tapas Bratha Tripathy, Professor, Department of PG Studies in Kayachikitsa, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan, Karnataka, India.

Kitibha Kushta is a Raktapradoshaja Vikara where it is categorised under Kshudra Kushta. Acharya Charaka mentioned the involvement of Vata and Kapha in Kitibha Kushta and is compared with Psoriasis due to close resemblance of its symptoms. Psoriasis is a chronic inflammatory, non-communicable, painful, disfiguring, disabling, and hyperproliferative skin disease. It is a chronic, non-communicable, proliferative auto-immune skin disease affecting 2% of world population. The prevalence of psoriasis ranges between 0.09% and 11.4% in different populations around the world, making it a serious global concern. In India, the prevalence of psoriasis varies from 0.44 to 2.8%, According to Global Psoriasis Atlas (GPA) an estimated 3.59 million people in India and 100 million people world-wide are affected.

Objectives of the study: To evaluate the combined effectiveness of Abhayarishta Churna and Aragwadha Patra Lepa in management of Kitibha Kushta (Psoriasis).

Material and Methods: A total of 30 participants of either gender were included in the study using the random sampling method. Among 33 registered participants, 30 completed the course of study. They were administered with Abhayarishta Churna 6 grams twice a day after food with Anupana of Madhu for 30 days in combination with Aragwadha Patra Lepa application externally. Lakshanas of Kitibha Kushta were assessed as primary outcome measures and the PASI score was assessed as the secondary outcome. For statistical analysis, subjective parameters were assessed with Friedman’s test, Wilcoxon sign rank test. Objective parameters were assessed by Repeated Measures ANOVA.

Results: Statistically significant improvement was observed in the primary and secondary outcome measures of Kitibha Kushta (Psoriasis).

Conclusion: Combination of Abhayarishta Churna and Aragwadha Patra Lepa was found to be effective in the management of Kitibha Kushta (Psoriasis).

Keywords: Abhayarishta Churna, Aragwadha Patra Lepa, Kitibha Kushta, Psoriasis, PASI

Corresponding Author How to Cite this Article To Browse
Harish M Hadapad, Post Graduate Scholar, Department of PG Studies in Kayachikitsa, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan, Karnataka, India.
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Hadapad HM, Jadhav LL, Tripathy TB, An Open Label Single Arm Clinical Study to Evaluate the Combined Effectiveness of Oral Administration of Abhayarishta Churna and Aragwadha Patra Lepa in Kitibha Kushta (Psoriasis). J Ayu Int Med Sci. 2025;10(2):18-25.
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https://jaims.in/jaims/article/view/4033

Manuscript Received Review Round 1 Review Round 2 Review Round 3 Accepted
2025-01-26 2025-02-01 2025-02-08 2025-02-15 2025-02-23
Conflict of Interest Funding Ethical Approval Plagiarism X-checker Note
None Nil Yes 12.85

© 2025by Hadapad HM, Jadhav LL, Tripathy TBand 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].

Download PDFBack To ArticleIntroductionObjectives of the studyMaterials and MethodsObservationsResultsDiscussionConclusionReferences

Introduction

Kitibha Kushta is one among the Kshudra Kushta, presenting with the Shyavavarna, Kinakhara Sparsha and Parusha Lakshanas.[1] The disease which has spreading nature and which leads to disfiguration (Kushnati) of skin is known as Kushta. There is involvement of Tridosha in all Kushta but the predominance of Dosha makes the types & manifestation of Kushta different. Acharya Charaka has described the involvement of Vata and Kapha Dosha in Kitibha Kushta.[2] It is comparable to Psoriasis due to its invariable similarities in the signs and symptoms of Kitibha Kushta.

Psoriasis is one of the most common skin disorders. It is a papulosquamous disorder of the skin characterized by sharply defined erythematosquamous lesions. It is chronic and is well known for its course of remission and exacerbation.[3] Psoriasis is a chronic inflammatory, noncommunicable, painful disfiguring, disabling, hyperproliferative skin disease with a strong genetic predisposition[4] and autoimmune pathogenic traits.[5] Psoriasis typically affects the skin, its complication can lead to psoriatic arthritis, and other systemic diseases. Thus, it has been postulated that psoriasis is a systemic entity rather than a solely dermatological disease.[6]

The prevalence of psoriasis ranges between 0.09%[7] and 11.4%[8] in different populations around the world, making it a serious global problem. In India the prevalence of psoriasis varies from 0.44 to 2.8%, According to global psoriasis atlas (GPA)an estimated 3.59 million people in India and 100million are affected Worldwide, the incidence of new cases increased from 92 per 100,000 in 1990 to 99 in 2017(29), twice more common in males compared to females and most of the patients are in their third or fourth decade at the time of presentation.[9] Psoriasis has been shown to affect quality of life to an extent similar to the effects of other chronic diseases.[10]

It has a substantial psychological and social impact on a person’s life. Even though various treatment modalities are available in the contemporary system of medicine including topical therapy, corticosteroids, cytotoxic drugs, photochemotherapy, most of these treatment modalities have limitations.

It is important to note that they have substantial side effects when used for a longer period. With the increasing prevalence and its association with various co-morbidities, there is a need for study various aspects related to aetiopathogenesis, management, and impact on quality of life. Methods or modes of intervention in alternate.

It is one among the Ashtamahagada[11] As progresses it expresses the Lakshanas of Tridosha[12] leads to Upadrava stage and it is considered as Kashtatara Roga.[13] There arises the need for planning treatment. The combined formulations Abhayarishta Churna and Aragwadha Patra Lepa mentioned in Bhaishajya Ratnavali Kushtaroga Chikitsa Prakarana are indicated for Kitibha Kushta. Abhayarishta Churna comprises of Haritaki and Nimba. Haritaki has Kashaya Rasa Pradhana Lavana Varjita Pancharasa, Ruksha-Laghu Guna, Madhura Vipaka and Ushna Virya. It has properties like Tridoshahara, Anulomana, Rasayana, Kushtaghna, Kandughna, Hrudya, Vranahara, Shophagna.[14]

Nimba is Tikta, Kashaya Rasayukta, having Laghu-Ruksha Gunas, Sheeta Virya, Katu Vipaka and it has properties like Kapha-Pitta Shamana, Kushtaghna, Krimighna, Rakta Shodhana, Shothahara, Vishaghna, Deepana.[15]

Aragwadha Patra Lepa possesses Tikta Rasa. Laghu-Ruksha Guna, Ushna-Sheeta Virya, Madhura Vipaka[16] and Vatapitta Shamaka and Pittakapha Samshodhaka.[17]

Present study is taken up to statistically evaluate the combined effectiveness of the Abhayarishta Churna and Aragwadha Patra Lepa in Kitibha Kushta (Psoriasis).

Objectives of the study

To clinically evaluate the combined effectiveness of Abhayarishta Churna and Aragwadha Patra Lepa in the management of Kitibha Kushta (Psoriasis).

Materials and Methods

Source of data

Subjects with Kitibha Kushta (psoriasis) were selected from OPD of Sri Dharmasthala Manjunatheshwara college of Ayurveda and Hospital, Hassan.


Table 1: Methods of collection of data

Type of study Open label, single arm, clinical study
Group  Single
Sampling method Convenience sampling method
Test design Pre-test and post-test design.
Sample size 30
Total study duration 30 days
Observation during the study16th day and 31st day

Screening

A screening form was prepared with all aspects of history, signs and symptoms of Kitibha Kushta (Psoriasis) and clinical examination was done to make the diagnosis keeping in view inclusion and exclusion criteria.

Diagnostic Criteria

Diagnosis was made on the basis of any two Lakshanas of Kitibha Kushta[18] and any four clinical features of psoriasis.

  • Shyavavarna
  • Kinakharasparsha
  • Parushata
  • Sharpely demarcated papule with clear-cut borders
  • Noncoherent silvery scales
  • Glossy, homogeneous erythema
  • Auspitz sign
  • Candle grease sign

Inclusion Criteria

1. Subjects suffering with Kitibha Kushta less than 1 year of chronicity
2. Subjects of either gender, aged between 18-60 years[19]
3. Subjects willing to participate in the study and ready to sign informed consent form

Exclusion Criteria

1. Uncontrolled diabetes mellitus (HbA1C >7mg/dl)
2. Pregnant women
3. Lactating mother
4. Subjects with impaired cardiac, renal, and hepatic functions

Laboratory Investigation

1. Hemoglobin
2. Total Count & Differential Count

3. Erythrocyte Sedimentation Rate

Intervention

1. Abhayarishta Churna

Route of administration: Oral.

Quantity: 6gms twice a day after food.

Anupana: Madhu (Q.S)[20]

Duration: 30days[21]

2. Aragwadha Patra Lepa[22]

Route of administration: External application with Kanji

Quantity: Thickness of 1/4th Angula (1 Angula = 25.4mm) as Doshaghna Lepa[23] once a day and removed before it dries completely

Duration: 30days

Institutional Ethics Committee (IEC): The ethics clearance certificate from the Institutional Ethics Committee of Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan was obtained, and a photocopy is attached. IEC No: SDM/IEC/45/2022, CTRI Registration No: CTRI/2023/11/059880.

Assessment done on: Signs and symptoms of Kitibha (Psoriasis) were assessed by giving scoring on 1st day, 16th and 31st day of treatment.

Assessment criteria

1. Signs and symptoms of Kitibha Kushta (Psoriasis) was assessed on 1st day, 16th and 31st day of treatment, Scoring based on gradation of Lakshanas of Kitibha kushta.

  • Shyavavarna
  • Kinakharasparsha
  • Parusha

2. The activity of disease will be assessed by Psoriasis Area Severity Index Score (PASI)

Observations

In the present study total of 41 participants were screened, out of which 33 subjects were registered for the study, among them 30 subjects completed the study. Among 30 subjects maximum (n=11) were from the age group of 51-60 years and predominance of males (n=24).


29 subjects were belonged to Hindu religion, 12 subjects were from upper-middle-class group and majority of them (n=17) were from urban areas. 30 subjects had gradual onset, none subjects had relevant past and family history, 33 subjects had treatment history and Diet-wise distribution showed maximum (n=32) were following a mixed diet.

Results

Table 2: Friedman’s test applied to Subjective Parameters, showing significant improvement in symptoms like Shyava Varna, Kinakhara Sparsha, and Parushata.

ParameterVariableNMean RankX2P ValueRemarks
Shyava VarnaBT302.7545.516< 0.05S
16th Day2.05
31st Day1.23
Kina Khara SparshaBT302.9357.617< 0.05S
16th Day2.05
31th Day1.02
ParushataBT302.8353.509< 0.05S
16th Day2.10
31th Day1.07
BT - Before Treatment, N - Number of participants, P - Present, A - Absent, S - Significant, x2 - chi square

Table 3: Wilcoxon Signed rank test showing the combined effectiveness of Abhayarishta Churna and Aragwadha Patra Lepa On Shyava Varna

ParameterNegative ranksPositive ranksTiesTotalZ valueP valueRemarks
NMRSRNMRSR
BT-16th Day2010.502100.00.001030-4.130< 0.05S
16th-31th Day2111.002310.00.00930-4.491< 0.05S
BT-31th Day25133250.00.00530-4.462< 0.05S
BT- Before Treatment, N- Number of participants, P- Present, A- Absent, S- Significant, MR – Mean Ranks, SR – Signed Ranks

Table 4: Wilcoxon Signed rank test showing the combined effectiveness of Abhayarishta Churna and Aragwadha Patra Lepa on Kina Khara Sparsha

ParameterNegative ranksPositive ranksTiesTotalZ valueP valueRemarks
NMRSRNMRSR
BT-16th Day23122760.00.00730-4.564< 0.05S
16th-31th Day2613.503510.00.00430-4.725< 0.05S
BT-31th Day27143780.00.00330-4.820< 0.05S
BT - Before Treatment, N - Number of participants, P - Present, A - Absent, S - Significant, MR - Mean Ranks, SR - Signed Ranks

Table 5: Wilcoxon Signed rank test showing the combined effectiveness of Abhayarishta Churna and Aragwadha Patra Lepa on Parushata

ParameterNegative ranksPositive ranksTiesTotalZ valueP valueRemarks
NMRSRNMRSR
BT-16th Day168.501360.00.001430-4.60< 0.05S
16th-31th Day19101900.00.001130-1.941< 0.05S
BT-31th Day21112310.00.00930-4.57< 0.05S
BT - Before Treatment, N - Number of participants, P - Present, A - Absent, S - Significant, MR - Mean Ranks, SR - Signed Ranks

Table 6: Friedman’s test Showing the combined effectiveness of Abhayarishta Churna and Aragwadha Patra Lepa on PASI Score

ParameterVariableNMean RankX2P ValueRemarks
PASI ScoreBT303.0059.513< 0.05S
16th Day1.98
31st Day1.02
BT - Before Treatment, N - Number of participants, P - Present, A - Absent, S - Significant, x2 - chisqaure

Table 7: Wilcoxon Signed rank test showing the combined effectiveness of Abhayarishta Churna and Aragwadha Patra Lepa on PASI Score

ParameterNegative ranksPositive ranksTiesTotalZ valueP valueRemarks
NMRSRNMRSR
BT-16th Day3015.504650.00.00030-4.783< 0.05S
16th-31st Day29154350.00.00130-4.705< 0.05S
BT-31st Day3015.504650.00.00030-4.783< 0.05S
BT - Before Treatment, N - Number of participants, P - Present, A - Absent, S - Significant, MR - Mean Ranks, SR - Signed Ranks

Table 8: Repeated measure ANOVA test showing the combined effectiveness of Abhayarishta Churna and Aragwadha Patra Lepa on PASI Score

PASI ScoreNMeanGreenhouse-GeisserGreenhouse-Geisserdf-errorRemarks
dfFP
BT3018.9162.007.256<0.0528.00S
16th day14.736
31st day10.890
N - Number of subjects, BT - before treatment, S - Significant, NS - Non-significant, df - Degree of freedom

Repeated measure ANOVA with Greenhouse - Geisser correction was determined to show statistically significant difference in PASI Score between means over three intervals, i.e., BT mean was 18.916, 16th day mean was 14.736 and on 31st day mean was 10.890 with F score - 7.256.

Table 9: Greenhouse-Geisser Correction of Repeated measure ANOVA

Gross Score IGross Score JMean Difference
(I-J)
Std. errorSig95% confidence interval for differenceRemarks
LowerUpper
124.1801.209<0.0161.1077.253S
233.8471.230<0.0160.7206.973S
13-8.0272.078<0.0162.74613.307S
BT - Before treatment, S - Significant

The difference between the three means had statistically significant difference with P<0.05. Statistically significant improvement in PASI Score from 1st to 16th day with mean Difference 4.180. from 16th to 31st day mean difference at 3.847 and statistically significant decrease observed on 1st to 31st day (Gross 1-3) with a mean difference of -8.027.

Discussion

Present study was conducted to evaluate the combined effectiveness of Abhayarishta Churna[24] and Aragwadha Patra Lepa[25] in Kitibha Kushta (Psoriasis).

Nimba (Azadirachta indica) has Tikta, Kashaya Rasa, Katu Vipaka and Ushna Veerya by virtue of its properties it is Kapha-Pitta Shamaka, Kushtahara and Shothahara. It contains a variety of phytochemical compounds including Nimbin, Nimbidin, Nimbolide and limonoids, which contribute to the management of skin diseases by modulating various genetic pathways and other biological activities.[26]

Research indicates that the phenolic compounds in Nimba bark possess antioxidant and immunomodulatory properties. Immunomodulatory effects of Nimba might have helped in Psoriasis.[27]Haritaki (Terminalia chebula) has Tikta, Kashaya Rasa, Laghu Ruksha Guna, Ushna Veerya and Rasayana by Karma. It is mentioned in Bhavaprakasha as Varnya and Kushtahara, Anulomaka, Kanduhara and Tridosha Shamaka.[28]

Rasayanas have been claimed to possess immunomodulatory activity, they can depress or potentiate the host’s capacity to resist infection and tumours non-specifically or react specifically to a foreign substance.[29] Terminalia chebula (Haritaki) is rich in bioactive compounds like chebulagic acid and chebulinic acid, which contribute to its significant anti-psoriatic effects via the heme oxygenase (HO)-1 pathway. This pathway inhibits oxidative stress and NF-κB activity, leading to reduced inflammation and keratinocyte proliferation. In IMQ-treated mice, treatment with Terminalia chebula improved erythema and scaling, decreased epidermal thickness, and lowered levels of TNFα, IL-17A, IL-23, and MMP-9. It also reduced TBARS levels and increased GSH content, while decreasing ROS levels and keratinocyte proliferation in M5-treated cells. The anti-psoriatic effects were inhibited by zinc protoporphyrin IX (ZnPP), an HO-1 inhibitor, highlighting the role of HO-1 in its mechanism. Additionally, Terminalia chebula suppressed p65 NF-κB upregulation under psoriatic conditions, and ZnPP blocked this effect. Overexpression of p65 NF-κB diminished the reductions in inflammatory markers and keratinocyte proliferation, suggesting that HO-1-mediated downregulation of p65 NF-κB is crucial for its anti-psoriatic action.[30]

Aragwadha (Cassia Fistula) synonymed as Kushtasudana means destroyer of skin diseases[31] Kaphamedhavishoshanam[32] and Maladosha Virechaka is mentioned for the Patra of Avaragwada. It has Madhura Rasa, Guru-Snigdha Guna, Sheeta Veerya, Madhura Vipaka, Tridosha Shamaka, Kandugna, Kushtagna. It has Sramsana as Prabhava.[33] The leaves primarily contain flavonoids glycosides, free rhein, sennosides A and B, isofavoneoxalic acids and oxyanthraquinones Pharmacological activities include anti-inflammatory, antioxidant, wound healing, anti-pruritic and antitumor. Studies shows Flavonoids are substances found in leaves of C. fistulas; Flavonoids have been recognized to play a role in inhibiting pro inflammatory enzymes activated during inflammation [34]. Another study was performed to check the effects of the extract of C. fistula on the growth of Ehrlich ascites carcinoma and on the life span of tumor-bearing mice, and the results revealed that the extract increased life span and decreased tumor volume and viable tumor cell count.


Another study evaluated the antioxidant activity of fistula bark, stems, leaves and roots. It showed higher antioxidant activity. Which play an important role as free radical scavengers.[35]

Kanji has Madhura and Amla Rasa, Laghu Guna, Sheeta Veerya, Madhura Vipaka, Vata-Pitta Shamaka.[33] It is beneficial in conditions where the skin becomes dry, rough and cold due to Vata vitiation also reduces inflammation and redness in skin, Cleanses wounds and promotes healing due to its mild Kashaya and Amlarasa.

Discussion on probable mode of action of Lepa

Lepa pacifies Prakupita Sthanika Dosha.[36]

Mode of action of Lepa

Lepa comes in contact with the Roma and Romakupa which in turn are connected to the Tiryak Gata Dhamanis[37] which perform the function of Sweda Vahana. Lepa enters the sweat ducts and hair follicles. Hair follicles are important pathway for percutaneous absorption.[38] After the application of Lepa, Paka of Dravya occurs. Paka refers to the action of Bhrajaka Agni and Rasa Dhatwagni. It occurs by virtue of Ushna Guna of Bhrajaka Pitta which is responsible for Varna Utkarsha.[39] Rasa Tarpana will occur by virtue of Vyana Vata and Varna Utkarsha is thus achieved. Hence, it is quoted that Varnasampannah Rasapurnatvat.[40]

Conclusion

Abhayarishta Churna 6grams twice a day after food and Aragwadha Patra Lepa external application once a day is effective in the management of Kitibha Kushta (Psoriasis). It showed significant improvement in primary outcome measures such as Shyava Varna, Kinakhara Sparsha and Parushata. There was a significant improvement in the secondary outcome measure of the PASI score. The Null Hypothesis is thus rejected in favour of Alternative hypothesis.

Patient perspective

The patients were satisfied with the treatment in terms of reduction in Kandu, Raga, Pidaka, Mandala andRookshata and improvement in quality of life.

Patient consent

Informed consent for publication of this case study has been obtained from the patients.

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