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CLINICAL STUDY: ORIGINAL ARTICLE
Year : 2021  |  Volume : 15  |  Issue : 3  |  Page : 163-169

An open-labelled randomized clinical trial for the evaluation of Balaharidradi Lepa with and without Khadira Twaka Kwath in Vyanga (Melasma)


1 Department of Dravyaguna Vigyana, Shri Shirdi Sai Baba Ayurvedic College and Hospital, Jaipur, Rajasthan, India
2 Department of Dravyaguna Vigyana, National Institute of Ayurveda, Deemed to be University (De novo), Jaipur, Rajasthan, India

Date of Submission29-Jan-2020
Date of Decision27-Apr-2021
Date of Acceptance02-May-2021
Date of Web Publication25-Sep-2021

Correspondence Address:
Sukha Ram
Department of Dravyaguna Vigyana, Shri Shirdi Sai Baba Ayurvedic College and Hospital, Mundiyagarh, Kishangarh . Renwal, Jaipur - 303 603, Rajasthan
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/joa.joa_29_21

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  Abstract 


Introduction: Vyanga (Melasma) is a common disorder appearing on the face, causing skin discoloration. Niruja (painless), Tanu (thin), Shyava Varnayukta (hyperpigmentation), and Mandala (circular patches) are the peculiar diagnostic features of the disease. It is categorized as a Kshudra Roga (minor disease) in Ayurveda. Lepa (pack) and Kwath (decoction) are well-known medicines for Vyanga (Melasma). Balaharidradi Lepa and Khadira Twaka Kwath are defined as Vyangahara Dravyas in Ayurvedic Samhitas as they are having Vyangahara, Kushthaghna, Varnya, Krimighna, and Kantikara activity. This study aims to evaluate the effect of Balaharidradi Lepa with and without Khadira Twaka Kwath in Vyanga (Melasma). Materials and Methods: (i) Design: Open-labelled randomized clinical trial of thirty patients of either sex. (ii) Intervention: Group A (15 patients) was given Balaharidradi Lepa and Khadira Twaka Kwath, while Group B (15 patients) treated with Balaharidradi Lepa. (iii) Duration: 2 months. (iv) Outcome measures: photography. Results: All the two groups were compared by Kandu and Von luschan's color scale statistically significant results were observed in both Groups A and Group B. Conclusion: The present study supports the use of Balaharidradi Lepa and Khadira Twaka Kwath in treating Vyanga with the good acceptance by all treated patients.

Keywords: Ayurveda, cosmetics, Kantikara, Lepa, melasma, Vyanga


How to cite this article:
Ram S, Kotecha M, Chaudhary KJ. An open-labelled randomized clinical trial for the evaluation of Balaharidradi Lepa with and without Khadira Twaka Kwath in Vyanga (Melasma). J Ayurveda 2021;15:163-9

How to cite this URL:
Ram S, Kotecha M, Chaudhary KJ. An open-labelled randomized clinical trial for the evaluation of Balaharidradi Lepa with and without Khadira Twaka Kwath in Vyanga (Melasma). J Ayurveda [serial online] 2021 [cited 2021 Dec 1];15:163-9. Available from: http://www.journayu.in/text.asp?2021/15/3/163/326712




  Introduction Top


Vyanga means any dark spot or discoloration on the face. Acharya Susruta was the first to mention the whole group of such skin diseases, which have an adverse effect on the appearance of skin and personality of the human being. These diseases were collected under Kshudra Roga.[1]

In Ayurveda, Vyanga is explained as a Kshudra Roga[2] or Raktaja Roga.[3],[4] As per Ayurveda classics Krodha (anger), Aayaas (laziness), Ushna (hot in the property), Tikshna (sharp), Ruksha (dryness) dietary habits,[1] and in modern science exposure to sunlight and exposure to dust are causative factors for Vyanga. Maharshi Sushruta[1] and Vagbhatta[5] have narrated some specific etiology and Samprapti. This disease is mainly manifested due to vitiated Vata and Pitta Doshas and Rasa-Rakta Dushya. According to the modern view, the disease Vyanga can be correlated with Melasma. In this, the patches of hyperpigmentation are seen especially on cheeks, nose, forehead, and chin.[6] Women are more prone to this due to hormonal changes[7] occurring during menarche, pregnancy, and menopause and excessive use of cosmetic supplements.

Vyanga (Melasma) is a disease that has been around for centuries despite several treatment options. However, these agents have certain limitations, either due to compliance issues or due to poor efficacies. Hence, in this study, we tried to overcome this problem by the holistic system of Ayurveda, through local and internal use of the drug.

For the treatment of the Vyanga (Melasma), so many drugs are mentioned in Ayurvedic classics, which are having Vyangahara action. Among these, Balaharidradi Lepa (Bala-Sida cordifolia [Linn.], Atibala-Abutilon indicum [Linn.], Yashtimadhu-Glycyrrhiza glabra [Linn.], Haridra-Curcuma longa [Linn.]),[8] and Khadira Twaka Kwath-Acacia catechu (Willd.)[9] are selected for the study as Vyangahara and Kushthaghna dravyas. This study aims to evaluate the effect of Balaharidradi Lepa with and without Khadira Twaka Kwath in Vyanga (Melasma).


  Materials and Methods Top


Ethical clearance

Ethical clearance was taken from the Institutional Ethical Committee before commencing of the trial No. IEC/ACA/2018/6 and Dated 11/05/2018.

CTRI registration

Trial REF/2019/04/025147 has been registered. The registration number for this trial is CTRI/2019/04/018721.

Selection of drug

Balaharidradi Lepa and Khadira Twaka Kwath.

Collection and authentication of drug

Bala-S. cordifolia (Linn.) and Atibala-A. indicum (Linn.) were collected personally after proper identification. The plant was taxonomically authenticated by the botany department, University of Rajasthan, Jaipur vide reference number RUBL211726 and 727. Yashatimadhu-G. glabra (Linn.), Haridra-C. longa (Linn.), and Khadira-A. catechu (Willd.) were purchased from the market (Shri ram Herbals, Jaipur). The crude drug was identified and authenticated by CSIR-National Institute of Science Communication and Information Resources, New Delhi-110012 (NISCAIR), vide reference number NISCAIR/RHMD/Consult/2019/3487-88-1, 2, and 3.

Preparation of the drug

Collected drugs were purified and shade dried for powder preparation. Dried drugs were powdered and passed through a sieve (no. 85) to get a uniform particle size. Both the Lepa equal parts (1:1:1:1) and Kwath were prepared in the Rasayanashala (Pharmacy) of the National Institute of Ayurveda, Jaipur.

Dose

Balaharidradi Lepa by processing in rose water (pack) as required for external use. Khadira Twaka Kwath (decoction) – 20 ml of Kwath was given internally twice a day after meal.

Inclusion criteria

  1. Patients of clinical features with Vyanga.
  2. Patients of either sex.
  3. Patients of age between 16 and 60 years.


Exclusion criteria

  1. With a present history of skin disease, e.g., psoriasis, dermatitis, and vitiligo, etc., related to the face
  2. The person suffering from any infective or contagious skin disease or under medication with antibiotics, antifungal, and steroid
  3. Patients of uncontrolled hormonal disease
  4. Any kind of hereditary skin disorder
  5. Incurable skin disease is mentioned in Ayurveda Samhita
  6. With the present history of pregnancy and chronic constipation.


Withdrawal criteria

  1. During the trial, if any serious condition or any serious adverse effects require urgent treatment
  2. The patient himself wants to withdraw from the clinical trial
  3. Noncompliance patients.


Sampling technique

Patients fulfilling the inclusion criteria were selected, and an simple random sampling technique was followed for grouping the patients into two groups.

Selection of patients

The patients approaching the outpatient department of the Dravyaguna Vigyan, National Institute of Ayurveda Hospital, Jaipur, with the clinical signs and symptoms of Vyanga (Melasma) as per Ayurveda and modern texts were considered.

Criteria for diagnosis

For perfect diagnosis and assessment, a special research pro forma was prepared to incorporate all the signs and symptoms of the disease as well as the Dosha, Dushya, etc. Based on the pro forma, all the patients of the present study were examined in detail.

The interventional phase

The clinical study was intervened by the prescribed drug, specific diet restrictions, and local hygienic precautions. This phase covers the following points.

  • Grouping: All the patients were divided into two groups to compare the efficacy of the trial drug:
  • Group A: Fifteen patients were given Balaharidradi Lepa and Khadira Twaka Kwath
  • Group B: Fifteen patients were given Balaharidradi Lepa.


Consent of patients

All the patients selected for the trial have explained the nature of the study, and their consent was obtained on the pro forma before inclusion in the study.

Screening

Before treatment, complete blood count was done as a screening of patients; those who had more than 9% (g/dl) hemoglobin were included in the clinical trial.

Assessment criteria

Scoring

The difference in the size of the affected area was noted. The change in complexion was recorded using a digital camera in daylight. The improvement of the therapy was assessed based on the classical signs and symptoms reported in Samhitas and other parameters. All the features were assigned a particular score depending on their severity to assess the effect of the drug.

Subjective parameters scoring

(1) Shyavata (Darkness), (2) Parush sparsha (Dryness), (3) Daha (Burning Sensation), (4) Kandu (Itching) (0 – Normal, 1 – Mild, 2 – Moderate, and 3 – Severe); (5) size of patches (1 – 0–1 cm, 2 – 1–3 cm, 3 – 3–6 cm, and 4 – >6 cm); (6) color of patches (0 – Normal, 1 – Light brown, 2 – Brown, 3 – Dark brown, and 4 – Black).

Objective parameters scoring

(7) Von Luschan's color scale[10] [Figure 1]
Figure 1: Von Luschan's colour scale

Click here to view


(8) Total Melasma Area and Severity Index (MASI) Score[11]

(9) Total Melasma Severity Scale (MSS) Score.[11]

Statistical analysis

All the results are calculated using software - In-Stat GraphPad 3 (Jaipur, Rajasthan, India.). Intragroup comparison: For nonparametric data, Wilcoxon-matched Pairs signed ranks test was used. For parametric data, Paired t-test was used, and the results are calculated. Intergroup comparison: For nonparametric data, Mann–Whitney test was used. For parametric data, Unpaired t-test was used, and the results are calculated.

Insignificant – >0.05, significant -– ≤0.05, and highly significant – ≤0.001.


  Observations and Results Top


Assessment of therapy

Intragroup comparison

  • Effect of Balaharidradi Lepa and Khadira Twaka Kwath were found highly significant (P < 0.001) on Shyavata, Parush sparsha, Daha, size, color, Von Luschan's colour scale, total MASI score, and total MSS score. Moreover, one parameter Kandu was found significant (P < 0.05)
  • Effect of only Balaharidradi Lepa was found highly significant (P < 0.001) on Shyavata, Parush sparsha, size, color Von Luschan's color scale, Total MASI score, and Total MSS score. Moreover, two parameters Daha and Kandu were found significant (P < 0.05) [Table 1].
Table 1: Intragroup comparison: For subjective and objective parameters in Group–A and Group–B

Click here to view


Intergroup comparison

  • From the above table, it is clear that there was a statistically significant difference (P < 0.05) in the effect of therapies in Group A and Group B on Kandu. Although in Shyavata, Parush Sparsha, Daha, size, and color, no statistically significant difference (P > 0.05) was observed in the effect of therapies of Group A and Group B
  • From the above table, it is clear that there was a statistically significant difference (P < 0.05) in the effect of therapies in Group A and Group B on Von Luschan's color scale. There was no statistically significant difference (P > 0.05) in the effect of therapies in Group A and Group B on Total MASI and MSS Scores [Table 2].
Table 2: Intergroup comparison: For subjective and objective parameter in Group-A and Group-B

Click here to view



  Discussion Top


Shyavata

In Shyavata, highly significant relief was found in both Group A (75.55%, P < 0.001) and Group B (63.33%, P < 0.001). Comparing the percentage-wise relief, Group A seems to be more effective on Shyavata than Group B. The Khadira Twaka Kwath given internally in Group A helped in reduce the Shyavata by quenching Vata and Pitta by having Tikta[12] – Madhura[13] – Kashaya Rasa,[14] Snigdha – Pichchhilla Guna,[15] Shita Virya,[16] and Kushthaghna Prabhava.[17]

Parush Sparsha

The relief percentage found in Parush Sparsha is statistically highly significant where (P < 0.001) in both Group A (70.00%) and Group B (64.28%). Comparing the percentage-wise relief, Group A seems to be more effective on Parush Sparash than Group B. To the combined therapy of Balaharidradi Lepa and Khadira Twaka Kwath reduce the Parush Saparsh by quenching Vata by having Madhura Rasa and Snigdha – Pichchhilla Guna.

Daha

In Daha, highly significant relief was found in Group A (79.16%, P < 0.001), and significant relief was found in Group B (60.41%, P < 0.05). Comparing the percentage-wise relief, Group A seems to be more effective on Daha than Group B. The combined therapy of Balaharidradi Lepa and Khadira Twaka Kwath reduce the Daha by quenching Pitta by having Tikta – Madhura – Kashaya Rasa and Shita Virya.

Kandu

The relief percentage found in Kandu is statistically significant (P < 0.05) in both Group A (87.49%) and Group B (50.00%). Comparing the percentage-wise relief, Group A seems to be more effective on Kandu than Group B. Kandu was found in some patients in the study. The combined therapy of Balaharidradi Lepa and Khadira Twaka Kwath reduced Kandu by quenching Kapha by having Katu[18] -Tikta – Kashaya Rasa, Ruksha Guna, Katu Vipaka, and Kushthaghna Prabhava.

Size of patches and colour of patches

The relief percentage found in the size, color of patches are statistically highly significant where (P < 0.001) in both Group A (55.55%), (66.66%), and Group B (48.88%), (58.88%), respectively.

Von Luschan's color scale, total Total Melasma Area and Severity Index score, and total Melasma Severity Scale score

The relief percentage found in Von Luschan's color scale, Total MASI Score, and Total MSS Score are statistically highly significant where (P < 0.001) in both Group A (10.83%), (86.13%), (86.90%) and group B (7.71%), (73.89%), (73.89%), respectively.

Comparisons of the effect of therapy on inter groups

On comparing the results of two groups based on Shyavata, Parusha Sparsha, Daha, Kandu, size of patches, color of patches, Von Luschan's color scale, MASI score, and MSS score it was observed that Balaharidradi Lepa and Khadira Twaka Kwath (Group A) gave more relief as compared to Balaharidradi Lepa (Group B). There was a statistically significant difference (P < 0.05) in the effect of therapies in Group A and Group B on Kandu and Von Luschan's color scale.

All over mode of action of therapy

In all, the effect of the therapy; Balahariradi Lepa and Khadira Twaka Kwath (Group A) was found to be more effective in subjective parameter like Shyavata, Parush Sparsh, Daha, Kandu, Size and Color of patches [Figure 2], [Figure 3], [Figure 4], [Figure 5] as well as in objective parameters like Von Luschan's color scale, total MASI Score and total MSS Score as compared to Balaharidradi Lepa (group B). External (Lepa) with internal administration (Kwath) of the drug produced a better result than the only external application of Lepa. Because Vyanga is the Raktaja Vikara,[4] Lepa (face pack) with Kwath (internally) is more effective than only Lepa.[19]
Figure 2: Group-A: Before

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Figure 3: Group-A: After

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Figure 4: Group-B: Before

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Figure 5: Group-B: After

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Vyanga Roga is occurring due to the vitiation of Vata – Pitta Dosha. The predominant Rasa of the drugs are Madhura, Tikta, and Kashaya. Pitta is aggravated by anger and exertion. Vitiated Vata and Pitta get localized on the face and give rise to a patch on the skin, which is painless, thin, and brown-black colour. Therefore, Madhura, Tikta, and Kashaya Rasa subdue the Pitta, which is the main cause of the disease. The Guna of the drug is Laghu, Snigdha, and Pichchhila, which breaks the etiology of Vyanga by subsiding Vata and Pitta.

Madhura, Tikta, and Kashaya Rasa acts as Brinhana,[20] Kantikara,[13] Varnya,[21] Dahashamaka, Kandughna, and Krimighna,[14] etc., pacifies vitiated Pitta and is Laghu in the property. Due to Madhura-Tikta– Kashaya Rasa and Shita Virya, it acts as Pittahara. The drug has Shita Virya and Kushthaghna Prabhava, which is beneficial for skin disorders like Vyanga, due to its Pittashamaka property. Shita Virya and Kushthaghna Prabhava are Varnya[17] as it endorses tissue firmness.

According to Ayurvedic texts, Bala, Atibala, Yashatimadhu, Haridra Lepa, and Khadira Twaka Kwath are Kantivardhaka, Ojhovardhaka,[22] Rasayana,[15] Dahashamaka, Varnya, Kandughna,[23] Kushthaghna, Vranashodhana, Krimighna,[24] and Ruchivardhaka,[25] etc. In the modern aspect, Balaharidradi Lepa, and Khadira Twaka Kwath have cooling, anti-inflammatory,[24] antioxidant, astringent, antiviral,[23] antibacterial, and antifungal effect.[22] Hence, it can be stated that the drugs are useful for skin disease externally as well as internally in combined therapy.


  Conclusion Top


The study proves Balaharidradi Lepa and Khadira are safe, effective, and traditionally acceptable drugs for reducing Vyanga (Melasma) in the affected population. Balaharidradi Lepa and Khadira Twaka Kwath combination provided more relief as compared to Balaharidradi Lepa alone. When used in patients with Vyanga Roga, Balaharidradi Lepa, and Khadira Twaka Kwath clear the affected area and were observed to be a safe and effective medication. These drugs did not produce any adverse drug reaction in the prescribed dose and duration.

Financial support and sponsorship

This study was financially supported by National Institute of Ayurveda, Deemed To be University (De novo), Jaipur – 302002, Rajasthan, India.

Conflicts of interest

There are no conflicts of interest.





 
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    Figures

  [Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5]
 
 
    Tables

  [Table 1], [Table 2]



 

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