E-ISSN:2456-3110

Research Article

Cassia fistula

Journal of Ayurveda and Integrated Medical Sciences

2023 Volume 08 Number 12 December
Publisherwww.maharshicharaka.in

A randomized controlled clinical study to evaluate the efficacy of Aragwadha Pushpa Lepa (Cassia fistula Linn.) in the management of Vyanga with special reference to Melasma

Nanditha M1*, Mahesh CD2, Pradeep S3
DOI:10.21760/jaims.8.12.1

1* M Nanditha, Final Year Post Graduate Scholar, Department of PG Studies in Dravyaguna, Sri Sri College of Ayurvedic Science and Research, Bengaluru, Karnataka, India.

2 C D Mahesh, Professor, Department of PG studies in Dravyaguna, Sri Sri College of Ayurvedic Science and Research, Bengaluru, Karnataka, India.

3 Seema Pradeep, Professor and HOD, Department of PG studies in Dravyaguna, Sri Sri College of Ayurvedic Science and Research, Bengaluru, Karnataka, India.

Vyanga is one of the Kshudraroga mentioned in the classics which are having Lakshana like Niruja, Tanu and Shyava Mandala. It can be correlated with Melasma in modern terms, which is also known as Chloasma. Melasma is an acquired pigmentary disorder, causing hyper-pigmented patches to appear on the facial skin. The prevalence varies between 1.5 % and 33.3 % in India. Female to male ratio in India is 4:1, indicating the high prevalence rate among females. Aragwadha Pushpa Churna along with Nimbuka Swarasa is applied over the hyper-pigmented patches in the condition of Vyanga in Cauvery river stretch of Namakkal district of Tamil Nadu as a folklore practice. A randomized clinical study was carried out to compare the efficacy with Varnya Gana Churna. The clinical study in the sample size of 30 was carried out in 2 groups with the intervention of Group A being Aragwadha Pushpa Churna Lepa and that of Group B being Varnya Gana Churna Lepa, with 30 days of drug application period and 15 days of drug-free follow up period. Differential diagnosis was ruled out with the help of Wood’s lamp. Assessment was done with the help of criterias like Amount of discolouration, Arbitrary grading and Area of the lesion. Various statistical tests like Parametric, Non-parametric, Friedman repeated measures ANOVA on ranks, etc. were carried out to analyse the results of the study. Both Aragwadha Pushpa Churna and Varnya Gana Churna have significant effect in the management of Vyanga with special reference to Melasma. When improvement in the individual criteria was compared, Aragwadha Pushpa Churna showed better results in reducing the amount of discolouration

Keywords: Aragwadha, Cassia fistula Linn., Chloasma, Melasma, Vyanga

Corresponding Author How to Cite this Article To Browse
M Nanditha, Final Year Post Graduate Scholar, Department of PG Studies in Dravyaguna, Sri Sri College of Ayurvedic Science and Research, Bengaluru, Karnataka, India.
Email: 		Nanditha M, Mahesh CD, Pradeep S, A randomized controlled clinical study to evaluate the efficacy of Aragwadha Pushpa Lepa (Cassia fistula Linn.) in the management of Vyanga with special reference to Melasma. J Ayu Int Med Sci. 2023;08(12):1-7.
Available From
https://jaims.in/jaims/article/view/2861

Manuscript Received Review Round 1 Review Round 2 Review Round 3 Accepted
2023-10-06 2023-10-13 2023-10-20 2023-11-03 2023-11-14
Conflict of Interest Funding Ethical Approval Plagiarism X-checker Note
None declared Nil Yes 12.36

© 2023by Nanditha M, Mahesh CD, Pradeep Sand 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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Nanditha M et al. Aragwadha Pushpa Lepa in management of Vyanga

Introduction

Normal healthy skin has many important roles and thus should be treated with care. There will be a focus on the skin once there is an abnormality. Vyanga is one such Vyadhi mentioned in our classics having Lakshanas like Niruja, Tanu and Shyava Mandala on Mukha Pradesha,[1] which can be co-related with Melasma, which is considered to be problematic if undesirable. Melasma, which is also called as Chloasma is a pigmentation disorder that causes discoloured patches to appear on the face, which may affect the lifestyle of a person. The prevalence of Melasma varies between 1.5% and 33.3% in India. It also occurs in men, though less common. Men represent 20.5 % - 25.83 % of the prevalence rate.[2] As per the studies, patients of Melasma are facing unsightly effect on personal appearance with the feeling of shame, frustration, embarrassment, low self-esteem and lack of motivation.[3] In contemporary science, prescription of depigmenting agents containing Hydroquinone and Steroids for topical application are given in the condition of Melasma, which may cause adverse effects and are also having high relapse rate.[4] Hence, standardization of Ayurvedic drugs in this context is the need of the hour. Aragwadha Pushpa Churna is used with Nimbuka Swarasa in the form of Lepa for Vyanga in the Cauvery river stretch of Namakkal district of Tamil Nadu as a folklore practice.[5] As Aragwadha Pushpa is abundantly available throughout India & is cost-effective, its action on Vyanga was intended to be studied clinically, which contributes in improving the day-to-day practice. Varnya Gana Lepa, a combined preparation using 10 drugs of Varnya Gana mentioned in Charaka Samhita, which is proven to be effective in the management of Vyanga,[6] was taken as the control drug to re-establish and compare its efficacy levels with Aragwadha Pushpa Lepa.

Hypothesis

Null hypothesis (H0) = The efficacy of Aragwadha Pushpa Lepa is equivalent to the efficacy of Varnya Gana Lepa in the management of Vyanga with special reference to Melasma.

Alternate Hypothesis (H1) = The efficacy of Aragwadha Pushpa Lepa is different from the efficacy of Varnya Gana Lepa in the management of Vyanga with special reference to Melasma.

Methodology

Sample source

Thirty subjects fulfilling the inclusion criteria of Vyanga with special reference to Melasma, irrespective of their gender, religion, occupation, socio-economic status, and who were willing to give written informed consent were selected for the present study, who were visiting Out Patient Department (OPD) or In Patient Department (IPD) of Sri Sri College of Ayurvedic Science and Research Hospital, Kanakapura road, Bengaluru. Subjects were also selected from referral sources.

Study design

A randomized open-labelled parallel group active-controlled pre and post-test clinical study.

Inclusion criteria

1. Subjects of either gender with the age group between 21 - 60 years were selected.
2. Subjects fulfilling the diagnostic criteria of Vyanga with special reference to Melasma were randomly selected, irrespective of their religion, occupation and socio-economic status.

Exclusion criteria

1. Female on oral contraceptive pills, pregnant women and lactating women.
2. Who were on any hormonal therapy.
3. Known hyperpigmentation since birth.
4. Known inflammatory pigmentation.
5. Known malignant melanoma.
6. Any other condition interfering with the course of the treatment.

Diagnostic criteria

Subjects were diagnosed with the clinical signs and symptoms of Vyanga:

  • Niruja
  • Tanu
  • Shyava
  • Mandala

Cases of Melasma were also diagnosed with the help of Wood’s lamp.

Grouping

Thirty subjects fulfilling the criteria were selected and randomly assigned into two groups of fifteen each:


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Nanditha M et al. Aragwadha Pushpa Lepa in management of Vyanga
  • Group A: Aragwadha Pushpa Lepa (Trial group)
  • Group B: Varnya Gana Lepa (Control group)

Sampling technique

Subjects were randomly assigned into two groups by lottery method.

Intervention

Table 1: Showing the description of intervention

FeaturesGroup AGroup B
Sample size1515
InterventionAragwadha Pushpa LepaVarnya Gana Lepa
Medium for applicationNimbuka SwarasaSukhoshna Jala
DosageQuantity sufficientQuantity sufficient
Time of AdministrationMorningMorning
Trial period30 days30  days
Follow up45th day45th day

Method of application

Subjects were instructed to wash the face and wipe with a dry cloth. The drug powder was mixed with quantity sufficient lemon juice to attain the consistency of a paste, and was applied over the affected area. The Lepa was retained on the face till it dried and then the subjects were instructed to remove the Lepa with lukewarm water.

Thickness of Lepa - Thickness of Ardra Mahisha Charma (approximately 2.5 mm).
Time of application - Morning.
Duration of application - The Lepa was retained on the face till it dried.
Route of administration - Bahya Marga / External application.
Duration of the study - 45 days (30 days trial period + 15 days of drug-free follow up).
Ethical clearance - The ethical clearance was obtained from Sri Sri Institutional Ethical Committee for commencing the study, with the Ethical clearance number - SSIEC/207/2021.
CTRI registration - CTRI registration was done before starting the trial with the Registration number -CTRI/2022/07/043645.

Assessment criteria

1. Arbitrary grading on the symptom Mandalakara:

Table 2: Showing scores for Arbitrary grading

FeaturesScore
More than five circular lesions present over the face4
5 circular lesions present over the face3
3 to 4 circular lesions present over the face2
1 to 2 circular lesions present over the face1
No such circular lesions present over the face0

2. Area of the lesion assessed by Grid method:

The area affected was assessed by adopting the Grid method. That is, the area affected was measured by marking the margins of the patches one by one on a transparent paper. The sketched transparent paper was then put on a graph paper and surface area was noted down in square millimeters.

3. Amount of discolouration:

The discolouration was scored according to the density of pigmentation using a standard fairness scale (Fair & Lovely Fairness Meter).

Assessment schedule

Table 3: Showing assessment schedule in both the groups

0th dayPre-study assessment
15th dayAssessment during trial period
30th dayPost-study assessment
45th dayFollow-up assessment

Observation and Results

Presentation of recorded data obtained in both the groups are represented in tables and graphs. Statistical analysis was done by using the software SigmaStat 3.1. Both Aragwadha Pushpa Churna and Varnya Gana Churna have significant effect in the management of Vyanga with special reference to Melasma. When improvement in the individual criteria was compared, Aragwadha Pushpa Churna showed better results in reducing the amount of discolouration & the number of lesions. Whereas, Varnya Gana Churna showed better results in reducing area of the lesion.

Changes in amount of discolouration

Within the group: Table no. 4 and Figure 1 represents the changes in amount of discolouration within the group.

Between the groups: Table no. 5 represents the changes in amount of discolouration between the groups.

Changes in Arbitrary gradingWithin the group: Table no. 6 and Figure 2 represents the changes in Arbitrary grading within the group.

Between the groups: Table no. 7 represents the changes in Arbitrary grading between the groups.

Changes in area of the lesionWithin the group:


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Nanditha M et al. Aragwadha Pushpa Lepa in management of Vyanga

Table no. 8 and Figure 3 represents the changes in area of the lesion within the group.

Between the groups: Table no. 9 represents the changes in area of the lesion between the groups.

Figure 4: Represents the CONSORT flow chart or the study flow chart.

Table 4: Showing changes in amount of discolouration using paired sample test for within the group.

Group AGroup B
MeanSDSEMP ValueSig.MeanSDSEMP ValueSig.
BT14.072.940.760.0002HS153.360.870.0006HS
AT12.272.940.7613.472.850.74

Table 5: Showing changes in amount of discolouration using unpaired sample test for between the groups.

GroupsMeanSDSEMT ValueP ValueSig.
Group A12.272.940.761.13520.2659NS
Group B13.472.850.74

Table 6: Showing changes in Arbitrary grading using paired sample test for within the group.

Group AGroup B
MeanSDSEMP ValueSig.MeanSDSEMP ValueSig.
BT2.671.180.300.0230S2.801.320.340.0266S
AT2.071.100.282.271.280.33

Table 7: Showing changes in Arbitrary grading using unpaired sample test for between the groups.

GroupsMeanSDSEMT ValueP ValueSig
Group A2.071.100.280.45900.6498NS
Group B2.271.280.33

Table 8: Showing changes in area of the lesion using paired sample test for within the group.

Group AGroup B
MeanSDSEMPSig.MeanSDSEMPSig.
BT61.533377.560320.02600.0176S42.233346.865912.10070.0045S
AT20.533322.72825.868412.183314.03263.6232

Table 9: Showing changes in area of the lesion using unpaired sample test for between the groups.

GroupsMeanSDSEMT ValueP ValueSig
Group A20.533322.72825.86841.21070.2361NS
Group B12.183314.03263.6232


Figure 1: Showing Mean & SEM of amount of discolouration before treatment (BT) & after treatment (AT) in both groups.



Figure 2: Showing mean & SEM of Arbitrary grading before treatment (BT) & after treatment (AT) in both groups.



Figure 3: Showing mean & SEM of area of the lesion before treatment (BT) & after treatment (AT) in both groups.


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Figure 4: Showing the study flow chart

Discussion

Vyanga is a Kshudra Roga mentioned in our classics having Lakshanas like Niruja, Tanu and Shyava Mandala on Mukha Pradesha,[1] which can be co-related to Melasma. Melasma is a pigmentation disorder that results in hyper-pigmented patches on the facial skin, which may affect interpersonal interactions. Studies have shown that patients with Melasma experience a negative effect on their appearance due to the persistent exposure of patches, along with feelings of shame, aggravation, embarrassment, low self-esteem and lack of motivation that can lead to suicidal thoughts.[3] In India, the prevalence of Melasma ranges from 1.5 % to 33.3 %. Despite being less frequent, men account for 20.5 % to 25.83 % of the prevalence rate.[2] In the present study also, maximum number of subjects were females, supporting the global prevalence rate. In Contemporary medicine, depigmenting medications with steroids and hydroquinone are prescribed, but they may be associated with negative side effects and a high relapse rate.[4] Aragwadha Pushpa Churna along with Nimbuka Swarasa is applied in the condition of Vyanga in the Cauvery river stretch of Namakkal district of Tamil Nadu as a folklore practice.[5]

As Aragwadha is abundantly available throughout India, and as Pushpa is the part used, which makes the Dravya Sangrahana easier, the study was undertaken to compare the efficacy with Varnya Gana Churna mentioned in our classics & which is proven to be effective in the management of Vyanga.[6] This gave advantageous results as Aragwadha Pushpa Churna proved efficacious than Varnya Gana Churna, replacing ten Dravya by one.

Discussion on amount of discolouration - There is a highly significant difference from before the treatment to after the treatment with a p value <0.001 in both the groups. The effect size is better in Group A than in Group B. This indicates that Aragwadha Pushpa Churna is more beneficial in reducing the amount of discolouration.

Discussion on Arbitrary grading - There is a significant difference from before the treatment to after the treatment with a p value <0.05 in both the groups. The effect size in Group A is better than in Group B. This indicates that Aragwadha Pushpa Churna is more beneficial in reducing the number of hyper-pigmented lesions.

Discussion on area of the lesion - There is a significant difference from before the treatment to after the treatment with a p value <0.05 in both the groups. The effect size in Group B is better than in Group A. This indicates that Varnya Gana Churna is more efficacious in reducing the area of the lesion.

Discussion on relapsation of the condition - During the drug-free follow up period, 46.66 % of the subjects of Group B had relapsation of the condition i.e., area of the lesion measured was more than the 30th day (AT). Whereas in Group A, 100 % of the subjects did not have relapsation in any of the criterias. This indicates that Aragwadha Pushpa Churna is more efficacious in the management Melasma and also in preventing relapsation.

Discussion on mode of action - Nidana Sevana leading to the Prakopa of Vata & Pitta Dosha causes Dushti of Rasa & Rakta which can be tackled by Tikta Rasa and Snigdha Guna of Aragwadha Pushpa. Sthanasamshraya of Dushta Rasa & Rakta in Mukha Pradesha can lead to Sanga & Vimarga Gamana causing the Lakshana like Niruja, Tanu and Shyava Mandala. Snigdha Guna helps in increasing the Mardavata of Tvacha and decreases Vata Dosha. As it is Varnakara, it helps in the maintenance of Varna. Tikta Rasa helps in subsiding Pitta Dosha


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Nanditha M et al. Aragwadha Pushpa Lepa in management of Vyanga

and it is also having Kushtahara property, which helps in reducing the condition. Vishada Guna and Shodhana Karma of Tikta Rasa does Srotoshodhana, which helps in tackling Srotosanga.

Conclusion

Outcome of the present study proved that Aragwadha Pushpa Churna showed better results in the management of Vyanga when compared clinically with Varnya Gana Churna. But the statistical comparison revealed that the efficacy of Aragwadha Pushpa Lepa and Varnya Gana Lepa were equivalent in the management of Vyanga, supporting the null hypothesis. The practice of Aragwadha Pushpa Churna Lepa with Nimbuka Swarasa was found to be effective in the condition of Vyanga, as per the folklore claim. Relapse rate was almost nil among the subjects of Aragwadha Pushpa group in the drug-free follow up period, showing the long time effect the Dravya has in the condition of Vyanga. Aragwadha Pushpa is easily available and is cost effective. Also, uprooting of the trees may be avoided unlike the drugs of Varnya Gana which are having Moola as the useful part, hence contributing to the conservation of medicinal heritage. Result of the present study also highlighted the superiority of Ekamoolika Prayoga, as a single drug is as effective as a formulation in the management of Vyanga.

Acknowledgement

The authors are thankful to all the participants of the study for their valuable time & co-operation during the study.

Reference

1. Upadhyaya Y, editor. Madhava Nidanam of Acharya Madhavakara; Kshudraroga Nidanam: 55, verse 39-40. Varanasi: Chaukhambha Prakashan; 2008. p.249-50.

2. Sarkar R, Arora P, Garg VK, Sonthalia S, Gokhale N. Melasma update. Indian Dermatol Online J [Internet]. 2014 Oct [cited 2023 Jan 14]; 5(4): 426-35.

3. Zhu Y, Zeng X, Ying J, Cai Y, Qiu Y, Xiang W. Evaluating the Quality of Life among Melasma Patients using the MELASQoL Scale: A Systematic Review and Meta-Analysis. PLoS One [Internet]. 2022 Jan 27 [cited 2023 Feb 11]; 17(1).

4. Fletcher J. What is Melasma? [Internet]. Brighton, East Sussex, UK: Medical News Today; 2018 [updated 2018 Nov 16; cited 2023 Jan 14].

5. Thirumaran G, Ganesan CM, Nandakumar K, Paulsamy S. Ethnobotanical plants used as curatives for skin diseases in a Cauvery river stretch, Namakkal district, Tamil Nadu, India. Int J Res Biol [Internet]. 2014 Dec [cited 2022 Oct 20]; 4(8): 1589-94.

6. Pallavi G, Gupta KV, Shreevathsa M, Chate VA, Balakrishna DL. Clinical evaluation of Varnya Gana Lepa in Vyanga (Melasma). AYU [Internet]. 2015 Apr [cited 2022 Jan 17]; 36(2): 151-6.


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