E-ISSN:2456-3110

Research Article

Somaraji Taila

Journal of Ayurveda and Integrated Medical Sciences

2024 Volume 9 Number 11 NOVEMBER
Publisherwww.maharshicharaka.in

An In-vitro, In-vivo and Clinical Trials of Somaraji Taila in the management of Dadru Kushta

Gadgade P1*
DOI:10.21760/jaims.9.11.5

1* Prashanth Gadgade, Post Graduate Scholar, Department of Kayachikitsa, Alva's Ayurveda Medical College, Moodabidire, Karnataka, India.

Dermatophytosis has become a significant health problem affecting children, adolescents, and adults worldwide. In India 5 out of 1000 people suffer from Tinea infections. The present study evaluated the antifungal activity of Somaraji Taila in Tinea (Dermatophytosis) in Invitro & Invivo model. Cultures were brought from MTCC a government body and inoculated in SDA media under aseptic condition. Later it was subjected to microscopic and macroscopic examination to identify the organism. A sensitivity test was done using SDA media by well diffusion method, with 4 different concentrations of Hydro-Methanolic extraction of Somaraji Taila ingredients. After the incubation period, the zone of inhibition was checked and was measured in mm. As the next phase of the study, animal study was also conducted to check antifungal properties & anti-dermal toxicity on albino rat skin and conducted clinical study on 30 Diagnosed subject Dadru Kushta who were randomly allocated with 15 each in two groups. Somaraji Taila was taken for one group which was compared against widely used clinical formulation Chakramarda Taila taken as standard for local application in another group. The application was done for 14 days, and the data was collected from the subjects at baseline, 8th day (during treatment), 15th day (after treatment) and 21st day (follow-up). The assessment was based on the KASI method of grading. The results of the study showed that there was there was highly statistically significant difference between the effect of Somaraji Taila and Chakramarda Taila in Dadru Kushta.

Keywords: Ayurveda, Dadru Kushta, Tinea Infection, Ringworm Infection, Somaraji Taila

Corresponding Author How to Cite this Article To Browse
Prashanth Gadgade, Post Graduate Scholar, Department of Kayachikitsa, Alva's Ayurveda Medical College, Moodabidire, Karnataka, India.
Email: 		Gadgade P, An In-vitro, In-vivo and Clinical Trials of Somaraji Taila in the management of Dadru Kushta. J Ayu Int Med Sci. 2024;9(11):29-37.
Available From
https://jaims.in/jaims/article/view/4026

Manuscript Received Review Round 1 Review Round 2 Review Round 3 Accepted
2024-10-13 2024-10-19 2024-10-29 2024-11-09 2024-11-19
Conflict of Interest Funding Ethical Approval Plagiarism X-checker Note
None Nil Yes 12.37

© 2024by Gadgade Pand 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].

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MethodsObservationsResultDiscussionConclusionReferences
Prashanth G et al. An In-vitro, In-vivo and Clinical Trials of Somaraji Taila

Introduction

The health of a person is reflected in their skin, which serves as a protective organ.[1] It is a frequent target organ for infections. Around 10–20% of patients in routine clinical setup experience skin illnesses, of which fungal infections account for up to 20%.[2] A World Health Organization (WHO) review of prevalence studies done on skin diseases reported an overall prevalence ranging from 21% to 87%.[3] In Ayurveda, references are given regarding the testing of drug and food on animals for evaluating administration to the safety before human beings. Yogya Vidhi, a separate chapter in Sushruta Samhita Sutrasthana, addresses this. Any operation that is done on humans should ideally first be tested on animals or other models that have comparable features.[4]

Therefore, it is imperative to conduct an in vitro and in vivo study to assess the effectiveness of Somaraji Taila on dermatophytosis before administering it on the patients. Dadru is a variety of Kushta with Rasa, Rakta, Mamsadhatu involvement.[5] Its aetiology includes Aharaja, Viharaja, Chikithsaapacharaja, Upasargaja and Krimija factors.[6] It is identified by symptoms such as Kandu, Deergha Pratana, Utsanna Mandala,[7] Raaga, Pidaka with predominance of Pitta Kapha Dosha.[8] Tinea is a group name for a highly contagious, segmented mycelia fungus.[9] Tinea is analogues to Dadru in contemporary science.[10]

Materials and Methods

Sample Collection

The fungal sample for invitro and In Vivo were collected from MTCC Chandigarh in the form of Freezed Dried Samples later they were activated by adding 0.4ml of Sterile Distilled water and transferred into a slant SDA media to grow for 7days once grown then confirmed under microscope (40X).

The ingredients used of Somaraji Taila are Bakuchi seeds, Haridra Khanda, Daruharidra Moola, Sarshapa Seeds, Kushta Moola, Karanja Seeds, Chakramarda Seeds, Aragwadha Patra. All the used parts were authenticated by Dravyaguna Department of Alva’s Ayurveda Medical College, Moodubidire. Somaraji Taila was prepared in RSBK Lab of AAMC, Moodubidire.

Source of Data

For In vitro Study

The Somaraji Taila ingredients were tested on 4 fungal sample i.e., Trichophyton Rubrum (MTCC7859), Trichophyton Mentagrophytes (MTCC 7687), Microsporum Gypsum (MTCC 2819), Microsporum Canis (MTCC 2820) in Microbiology Department of Alva’s Health Center, Moodubidire.

For In vivo Study

Before proceeding animal study, the room where animal was kept was bubble wrapped entirely to limit the spread the infection. Wister albino rats aged 14-15weeks weighing 200-250gms obtained from Alvas Animal House, Alvas Ayurveda Medical College and Hospital, Moodubidire. The rats were individually housed in propylene cage at room temperature. The animals were feed pellet diet and water.

For Clinical Study

OPD & IPD of PG Department of Kayachikitsa, Alva’s Ayurveda Medical College, Moodubidire.

Method of Collection of Data

Selection of Subjects: Irrespective of gender, religion, occupation, marital status, socio-economic status and education status.

  • Sample size: 30 participants
  • Grouping: 2 arms (A and B)
  • Number: 15 in each arm
  • Study design: A Randomized Parallel-Group Comparative Clinical Study
  • Blinding: Single-blind
  • Method of sampling: The lottery method

Diagnostic Criteria

Screening of Organisms like T. Rubrum, T, Mentagrophytes, M. Gypsum, M.Cannis, E.Floccosum is done by KOH Mounting Method Based on following Lakshana of Dadru.

  • Kandu
  • Daha

With or Without

  • Udgata Mandala
  • Raga
  • Pidaka

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  • Rookshata

Inclusion Criteria

  • Subjects who gave written consent
  • Subjects who fulfilled diagnostic criteria
  • Subjects with age group between 18 to 60 years

Exclusion Criteria

  • Subjects who have lesion with secondary infections.
  • Subjects with any other systemic disorder.

Interventions

  • Group T: Subjects were given Somaraji Taila for Local application for 14 days BD dose.
  • Group S: Subjects were given Chakramarda Taila for Local application for 14 days BD dose.

Observation Period

Treatment Period: 14 Days

Days of Assessment:
0th Day - At Baseline
8th Day - During Treatment
15th Day - After Treatment
21st Day - Follow up

Assessment Criteria

  • KASI[11] method of grading

Statistical Methods

  • Central tendencies and dispersions were measured using Mean, Median, Standard Deviation, Standard Error and Quartiles.
  • Tests of significance were done using paired 't' test and the unpaired 't' test, Anova Test, Mann Whithey Test, Wilcoxson Signed Rank Test.

Observations

Gender: Among 30 subjects 17 (63.3%) were males & 13 (36.7%) were females Tinea is more common in boys than girls during adolescence, because boys will have more sebaceous secretion, excessive sweating & they are more exposed to sunlight than girls.

Age: Total 30 Subjects maximum number of subjects 63.3% belongs to the age group of 21-30 years This may be due to increased sebaceous gland activity in adolescent age group which favours the growth of fungal infection & other contributing factor is lack of hygiene.

Religion: Among 30 subjects, 27 of them belong to Hindu Religion. The fact may be the area where the study was conducted was having predominance of Hindu Religion.

Socio-Economic status: Among 30 subjects, maximum number of 19 (63.3%) belong to middle class, 11 (36.6%) were from Upper-middle class. This is due to the region prominent with middle class.

Occupation: 33.6% of the subjects were students and 36.3% were housewives. This may be due to excessive house work lead to sweating and creates moist area which helps in growing fungus and fungal hyphae.

Diet: Most of the patients i.e., 70% were of mixed diet. As the study was conducted in coastal area and more over eating habits of coastal area is mixed diet.

Chronicity: Among 30 Subjects 73.3% were having Acute onset due to the spreading nature of the fungal spore and unhygienic maintenance of the body, clothes and surrounding area.

Prakrithi: Among 30 subjects, 80% subject having Pitta-Kapha Prakriti where as 20% are of Vata-Pitta as Dadru Kushta is Kapha Pittaja Vyadhi same Prakriti patient has been diagnosed.

Aggravating factors: In the present study 93.3% had excessive sweating and 3.3% was due to Dust exposure. This may be because sweating creates moist environment around the area which triggers fungal hyphae to grow further.

Skin Texture: Among 30 Subjects 80% were having Oily skin texture where as 20% were having dry skin texture, oily skin texture plays an role by nourishing the fungal cells hence sporulation of fungal spore is excess when compared to dry skin texture.

Organism: Among 30 subjects 60% subject were affected due to infection by Trichophyton Mentagrophytes where as 40% subjects were affected by Trichophyton rubrum, when we consider prevalence rate of fungal infection in Dakshin Kannada 45-87% of fungal infection is because of Trichophyton Mentagrophytes and Trichophyton Rubrum due to presence of moist climate.

Affected Area: Among 30 subjects 8 (26.6%) had affected on groins,


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7 (23.3%) had affected under breast, 5 (16.6%) had affected on abdomen and hands, 2 (6.6%) had affected on hands and on scrotum, 1 (3.3%) had affected on gluteal, area of infection also plays role in spreading and severity due to moist area and friction of the area helps fungal spore to spread.

Result

The whole study was carried out in Phase 0 (Laboratory Study), Phase 1 (Animal Study), Phase 2 (Clinical Study), of Research Methodology.

Phase 0: Results is, there is Anti-Fungal activity observed in any one or more than one organism with one or more extracts and formulations in well diffusion method using SDA in In Vitro study as shown in Table No. 1.

Phase 1: Results is, there is Statistically significant effect of Somaraji Taila which is better than control and standard or equal to standard group as shown in Table No 2

Phase 2: Result, the study was carried out on 30 subjects divided into 15 each group. Group S received Chakramarda Taila whereas, Group T received Somaraji Taila. The data was collected from subjects at baseline, 8th day (during treatment), 15th day (After Treatment), and 21st (After Follow up). The obtained data were subjected to statistical evaluation by applying Paired and unpaired T test, Anova test, Mann Whitney test and Wilcoxson signed rank test to evaluate the effectiveness of the interventions. There was statistically significant difference in assessment parameter in both group on 8th Day, 15th Day and 21st Day. When compared to the baseline shown in Table No 3.

On Kandu it shows There is Statistically Significant with p<0.05 when results compared with BT & D8, BT & D15, BT & FU shown in Table No 4. On Daha it shows There is Statistically Significant with p<0.05 when results compared with BT & D8, BT & D15, BT & FU shown in Table No 5. On Udgata Mandala it shows There is Statistically Significant with p<0.05 when results compared with BT & D8, BT & D15, BT & F6 shown in Table No 6. On Raga it shows There is Statistically Significant with p<0.05 when results compared with BT & D8, BT & D15, BT & FU shown in Table No 7. On Pidakas It shows There is Statistically Significant with p<0.05 when results compared with BT & D8, BT & D15,

BT & FU shown in Table No 8. On Rukshata it shows there is Statistically significant with p<0.05 when result compared with BT & D8, BT & D15, BT & FU shown in Table No 9. On KASI Score it shows there is statistically significant with p<0.05 when result compared with BT & D8, BT & D15, BT & FU, shown in Table No 10.

Discussion

Probable Mode of Action

The Somaraji Taila contains a total of 8 ingredients and they are Bakuchi, Haridra, Daruharidra, Sharshapa, Karanja, Kushta, Chakramarda, Aragwadha all these 8 ingredients have synergetic effect with one another but individually having different actions and they are as follows

Bakuchi (Psoralea corilifolia) belonging to Fabaceae family having Katu, Tikta Rasa, Laghu, Rooksha Guna, Ushna Veerya, Vata-Kapha Hara which help in reducing Kledata acts as Kandughna, Krimighna, Kushtaghna, used part is Beejas and contains Psoralen, Isopsoralen, Bavachromene, Bakuchiol.

Psoralen a compound has the ability to disrupts fungal cell wall and inhibits fungal DNA synthesis, Bakuchiol exhibits broad spectrum antimicrobial activities.

Haridra (Curcuma longa) belonging to Zingiberaceae family having Tikta, Katu Rasa, Laghu Rooksha Guna, Ushna Veerya, and Tridosha Hara helps in reducing Daha, Kledata, Kandu and acts as Kandughna, Kushtaghna, Krimighna, Sophahara, Dahahara, used part is Moola and contains Curcumin, Curcuminoids, Volatile Oils.

Curcumin has strong antifungal properties which exerts by inducing oxidative stress within fungal sells, disrupting membrane integrity and interfering with fungal cell signaling pathway.

Daruharidra (Berberia aristata DC) belonging to Berberidaceae family having Tikta, Kashaya Rasa, Laghu Rooksha Guna, Ushna Veerya and Kapha Hara which help in reducing Kleda, Daha and acts as Kandughna, Kushtaghna, Sophahara, Krimighna, used part is Moola contains Berberin, Berbamine, Oxycanthine, Berberrubine. Berberine an alkaloid with significant antifungal effect acting by inhibition ergosterol synthesis which is vital to fungal cell wall membrane.


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Sharshapa (Brassica nigra L. Koch) belonging to Cruciferae family having Katu Rasa, Teekshana Guna, Ushna Veerya, Vata-Kapha Hara Property which help in Kleda, Daha Hara and acts as Sophahara, Krimighna, Kandughna, Kushtaghna, used part is Seeds and contains Steraric acid, Oleic Acid, Linolenic Acid, Esosenic Acid, Indole. Seeds contain allyl-isothiocynate, this compound disrupts the cell membrane integrity of fungi leading to leakage of cellular contents & leads to cell death. Glucosinolate a compound when hydrolyzed it produces various compound including isothiocyanate which have potent antifungal effect.

Kushta (Saussurea lappa CB. Clarke) belonging to Asteraceae family having Tikta, Katu, Madhura Rasa, Laghu, Rooksha, Teekshna Guna, Ushna Veeyra, having Vata-Kapha Hara which helps in Kleda Hara and acts as Kushtaghna, Krimighna, as it helps stopping the spreading of infection. Used part is Moola and contains Kusthin, Saussureal, Taraxasterol. Sesquiterpene lactone, dehydrocosten lactone, costunolide known to their strong antifungal & antimicrobial activities. Sesquiterpene exhibits antifungal property by inhibiting the synthesis of fungal cell wall & interfering with fungal enzyme activity. Castanosides help in apoptosis in fungal cells by generating reactive oxygen species (ROS) & disrupting mitochondrial function.

Karanja (Pongamia pinnata) belonging to Fabaceae family having Tikta, Katu, Kashaya Rasa, Laghu Teekshna, Ushna Guna, Vata-Kapha Hara which help in Kleda, Daha Hara and acts as Kushtaghna, krminghna, Used part is Beeja and contains Glabarin, Karanjin, Pongapin, Pongamol. Flavanoids, Karanjin & Pongamol having antimicrobial properties. Karanjin & pongamol interfere with fungal cell wall synthesis and disrupts membrane integrity leading to cell lysis and cell death. Flavonoids is having broad spectrum antimicrobial activity & enhance the overall antifungal efficacy by inhibiting fungal enzyme & DNA synthesis.

Chakramarda (Cassia tora Linn.) belonging to Caesalpiniaceae family having Katu Rasa, Laghu Rooksha Guna, Ushna Veerya, Vata Kapha Hara and acts as Krimighna, Kauhstghna, which help in reducing spread of infection. Used part is Beeja and Contains Oleic Acid, Lenolic Acid, Palmitic Acid, Sitosterol’s. Seeds are rich ion flavonoids, anthraquinones and phenolics compound which contributes to its antifungal activity.

Anthraquinones exhibits antifungal effect by interfering with the mitochondrial electron transport chain by fungi leading to energy depletion and leads to cell death. Flavonoids enhances membrane permeability, causing leakage of cellular content and inhibit fungal spore germination.

Aragwadha (Cassia fistula) belonging to Caesalpiniaceae family having Madhura Rasa, Mrudhu, Guru Snigdha Guna, Sheeta Veerya, Kapha-Vata Hara helps in Kandu, Daha Hara and acts as Kushtaghna, Krimighna, Kandughna. Used part is Patras which contains Anthraquinone, Lenoceric Acid, ß-Sitosterol’s. Anthraquinone, flavonoids, and tannins which has antimicrobial properties. Anthraquinones these help in disrupt mitochondrial function and energy production in fungal cells. Tannins precipitate proteins and inhibit fungal enzymes, hence preventing fungal growth and reproduction. Flavonoids act by inhibiting fungal cell wall synthesis & inducing oxidative stress within fungal cell wall.

These all herbs work in synergetic effect to balance the impaired Doshas, purify the blood and direct combating fungal infection, their unique bioactive compound disrupt fungal cell wall and membrane inhibiting essential enzymes, generating oxidative stress and interfere with fungal DNA and energy synthesis. This synergetic effect enhances the efficacy of Somaraji Taila making it a potent natural Taila preparation for Dadru Kushta.

Conclusion

Dadru Kushta being Pitta Kapha Pradhana Vyadhi & show symptoms like Kandu, Udgata Mandala, Raga, Pidaka, Daha, Rookshata. It mainly occurs due to Krimija & Upasargaja Nidanas, so one should maintain hygiene to prevent spread. Both Somaraji Taila & Chakramarda Taila were effective in treating Dadru Kushta but Somaraji Taila gave better relief than Chakramarda Taila due to presence of 8 anti-fungal ingredients when compare to Chakramarda Taila has only one ingredient. In comparison between two group there was highly statistically significant with p<0.05. Since all Lakshanas statistical shown highly statistically significant conclusion was drawn that, There is Statistically significant difference in effect of Somaraji Taila & Chakramarda Taila with Somaraji Taila having better effect than Chakramarda Taila in management of Dadru Kushta.


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Table 1: In-Vitro Zone of Inhibition.

OrganismsStandard DrugTrial Drug(µg/l)
25100250500
Trichophyton Rubrum34 mm013 mm18 mm21 mm
Trichophyton Mentagrophytes17 mm011 mm16 mm18 mm
Microsporum Gypsum16 mm00014 mm
Microsporum Canis10 mm0013 mm14 mm

Table 2: Showing Scoring details of In-Vivo Study

GroupDay 0Day 8Day 15Day 21
Group 10000
0000
0000
Group 23333
3333
3333
Group 33211
2221
3210
Group 43320
3220
3210
Group 53221
3221
3321

Table 3: Showing the effect of Group S & Group T on KASI Scoring

GroupPairingQ ValueP<0.05GroupPairingQ ValueP<0.05
Group SBT-D85.47YesGroup TBT-D812.02Yes
BT – D155.47YesBT – D1516.2Yes
BT – AFU10.59YesBT – AFU13.4Yes
D8-D1511.1YesD8-D155.47Yes
D8-AFU5.47NoD8-AFU11.1Yes
D15-AFU5.47NoD15-AFU8.37Yes

Table 4: Showing the effect of Group S & Group T on Kandu

KanduMedian ScoreMann Whitney TestRemarks
Group SGroup TT ValueP Value
BT - D80.01.0165.5P=0.006SS
BT - D151.02.0170.5P=0.01SS
BT - AFU2.03.0177.5P=0.02SS
D8 - D151.01.0222.5P=0.6NS
D8 - AFU2.02.0224.5P=0.7NS
D15 - AFU1.01.0241P=0.7NS

Note: SS - Statistically significant, NS - Not Significant

Table 5: Showing the effect of Group S & Group T on Daha

DahaMedian ScoreMann Whitney TestRemarks
Group SGroup TT ValueP Value
BT – D81.01.0218.5P=0.5NS
BT–D151.02.0198P=0.1SS
BT-AFU2.03.0193.5P=0.1SS
D8-D151.01.0206P=0.2NS
D8-AFU1.02.0205.5P=0.2SS
D15-AFU1.01.0225.5P=0.7NS

Note: SS - Statistically significant, NS - Not Significant

Table 6: Showing the effect of Group S & Group T on Udgata Mandala

Udgata MandalaMedian ScoreMann Whitney TestRemarks
Group SGroup TT ValueP Value
BT – D81.02.0251P=0.4SS
BT–D 151.02.0162.5P=0.04SS
BT-AFU1.02.0150.5P=0.01SS
D8-D150.01.0177P=0.02SS
D8-AFU1.02.0164P=0.005SS
D15-AFU1.01.0243.5P=0.6NS

Table 7: Showing the effect of Group S & Group T on Raga

RagaMedian ScoreMann Whitney TestRemarks
Group SGroup TT ValueP Value
BT – D80.01.0210P=0.3SS
BT–D 151.02.0176.5P=0.02SS
BT-AFU2.03.0180.5P=0.03SS
D8-D151.01.0190P=0.08NS
D8-AFU2.02.0201P=0.1NS
D15-AFU1.02.0156.5P=0.02SS

Note: SS - Statistically significant, NS - Not Significant

Table 8: Showing the effect of Group S & Group T on Pidaka

PidakaMedian ScoreMann Whitney TestRemarks
Group SGroup TT ValueP Value
BT – D80.01.0186.5P=0.05SS
BT–D 150.01.0209.6P=0.03SS
BT-AFU0.01.0187.3P=0.05SS
D8-D150.00.0230.5P=0.9NS
D8-AFU0.00.0222P=0.6SS
D15-AFU0.00.0234P=0.9NS

Note: SS - Statistically significant, NS - Not Significant


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Table 9: Showing the effect of Group S & Group T on Rukshata

RukshataMedian ScoreMann Whitney TestRemarks
Group SGroup TT ValueP Value
BT – D83.07.0199P=0.1NS
BT–D156.013.0176.5P=0.02SS
BT-AFU8.021.0167.5P<0.05SS
D8-D153.06.0165.5P<0.05SS
D8-AFU4.013.0159.0P<0.05SS
D15-AFU2.06.0155.5P=0.02SS

Note: SS - Statistically significant, NS - Not Significant

Table 10: Showing the effect of Group S & Group T on KASI Scale

KASI ScoreMedian ScoreMann Whitney TestRemarks
Group SGroup TT ValueP Value
BT – D85.04.0257P=0.3NS
BT–D1512.08.0284P=0.03SS
BT-AFU16.011.0274P=0.08NS
D8-D155.03.0303P=0.004SS
D8-AFU8.05.0279P=0.05SS
D15-AFU4.03.0254P=0.3SS

Note: SS - Statistically significant, NS - Not Significant

Figure 1: Showing Reduction of lesion.

jaims_4026_01.JPG
0th Day

jaims_4026_02.JPG
8th Day

jaims_4026_03.JPG
21st Day

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