A clinical study on the effect of Arka Taila in the management of Karnasrava (Otomycosis).

Karnasrava is the condition characterized by discharge from Karna and occurs mainly due to Avarana of Vata Dosha. Otomycosis denotes diffuse otitis externa due to fungal infection in ear. Otomycosis being one of the causes of Karnasrava was selected for the study. The present study is done on 28 patients of Karnasrava, who were grouped in to two with 14 patients in each group. Group-A was treated with Arka TailaKarnapurana and Group-B with Clotrimazole ear drops (standard control). The signs and symptoms were studied before and after treatment. Result of the study indicates that Arka Taila and Clotrimazole are equally effective in all the signs and symptoms of Karnasrava (Otomycosis).

Introduction

Karnasrava is a disease mentioned by Acharya Sushruta in the chapter of Karnaroga Vigyaniya under twenty eight Karnarogas.[1] Acharya Charaka included Karnasrava as a symptom under the four types of Karnarogas due to vitiation of different Dosha.[2] Karnasrava (discharge) is one of symptom of otomycosis. In Vranasrava Vigyaniya Adhyaya, Acharya Sushruta has described many types of Srava. Out of them Twakagata and Mamsagata Srava is in parlance with modern otomycosis.[3]

Otomycosis is a type of otitis externa occuring due to fungal infection. In general population, the prevalence of otomycosis is 5.2% all over world and in India 9.00% according to American academy of otolaryngology. Further 5-25% of otitis externa cases are due to otomycosis. The 90% of fungal infections involve Aspergillus species and the rest Candida species.[4]

The general line of treatment of Karnasraava includes Shirovirechana, Dhupana, Karnapurana, Pramaarjana, Dhaavana, Prakshaalana etc.[5] In otomycosis, frequent cleaning of external auditory canal either by suction, evacuation, or by syringing, followed by moping are advised which are very similar to treatment of Karnasrava. Further topical medications are applied as disinfectant, anti-inflammatory, and antifungal.[6] For this study, clotrimazole has been selected as standard control. But it is having side effects like burning sensation, stinging sensation, etc. The treatment of this particular disease has never been satisfactory and therefore, a number of treatments were advised to relive this condition. So, to overcome above problems there is a need to find cheaper and easily available Ayurvedic medicine. In the present study, Arka Taila was selected as a local therapeutic procedure for Karnapurana.

Aims and objectives

To assess the efficacy of Arka Taila in the management of Karnasrava (Otomycosis)

To compare the efficacy of Arka Taila with clotrimazole in the management of Karnasrava (Otomycosis).

Materials and Methods

Selection of patients

The patients fulfilling inclusion criteria, attending the O.P.D. of Department of Shalakya, I.P.G.T and R.A. Hospital, Gujarat Ayurved University, Jamnagar were selected irrespective of age, sex, religion, race, occupation, etc.

A detailed proforma was prepared incorporating Ayurvedic and Modern points. Trial drug was prepared in the Department of R.S. and B.K., I.P.G.T. and R.A., Jamnagar.

Inclusion criteria

The selection of patients was done on the basis of signs and symptoms of Karnasrava (Otomycosis) described as per Ayurvedic and modern medical science.

Exclusion criteria

Patients suffering from any debilitating diseases like diabetes, T.B., etc. and with other aural pathology e.g. Chronic suppurative otitis media (CSOM), acute suppurative otitis media (ASOM), perforation of tympanic membrane, etc. were excluded from the study.

Sampling method

Random sampling method

Assessment criteria

The efficacy of the therapy was assessed on the basis of subjective criteria, for statistical analysis scoring was designed according to the severity of symptoms.

Overall effect of therapy

Cured: 100% relief in subjective and objective symptoms.

Marked improvement: 76-99% relief in subjective and objective symptoms.

Moderate improvement: 51-75% relief in subjective and objective symptoms.

Mild improvement: 26-50% relief in subjective and objective symptoms.

Unchanged: Upto 25% relief in subjective and objective symptoms.

Group, dose and duration

Group-A: Patients were treated with Arka Taila for Karnapurana (approx. 10-15 ml) for hundred Matra for 15 days with an interval of 5 days.

Group-B: Patients were treated with Clotrimazole eardrops. Two drops thrice daily for 15 days.

Follow-up of the treatment

Patients were asked to attend the O.P.D. for 1 month after completion of therapy for the follow up.

Statistical test

The data obtained on the basis of observations was subjected to statistical analysis in terms of mean, standard deviation error by applying the unpaired ‘t’ test. The results were interpreted at the level of P<0.001 as highly significant, P<0.05 or P<0.01 as significant, and P>0.01 as insignificant.

Preparation of Arka Taila

Arka Taila contains only three drugs viz. Arka Patra (Calotropis procera), Haridra (Curcuma longa) and Sarshapa Taila Brassica campestris).[7] Arka Taila was prepared by general method of preparation of Taila Kalpana till the Kharapaka stage.[8] Arka Taila has Katu and Tikta Rasa, Ruksha, Laghu, Tikshna Guna, Ushna Veerya, Katu Vipaka, and Kapha-Vatashamaka properties.

Design of study

The study was conducted on 28 diagnosed cases of Karnasrava. Patients were selected from OPD, Department of Shalakya, I.P.G.T. and R.A., G.A.U., Jamnagar. Out of which 02 patients discontinued the treatment. Remaining 26 patients completed the study.

Ethical clearance

The study was cleared by the institutional ethics committee. Written consent from each patient willing to participate before starting the study was taken. For those patients who were unable to read or write consent of their relative was taken. Patients were free to withdraw their name from the study at any time without giving any reason.

Observations and Results

In the present study, 21.42% patients belong to the age group of 51-60 years, 57.15% patients were male, 32.14% patients were house wives, and 82.14% patients were from middle class.

Maximum number of patients, i.e. 39.29%, were found having Nidana of water entry in ear followed by 28.57% having unknown etiology, 25.00% patients having Nidana of Pratishyaya, 17.87% patients were found having Nidana of scratching of ear, and 3.57% patients had history of ear scratching along with water entry into the ear and Avashyaya.

Majority of patients, i.e. 53.57%, were of Vata Kapha Prakriti, 60.71% patients were of Rajasika Manasa Prakriti, 92.86% patients were of Madhyama Samhanana, Sara, Satva, Aharashakti, Vyayamashakti and Vaya found. 82.14% patients were having Madhyama Satmya. Maximum number of patients, i.e. 39.28%, were having chronicity of 6-10 days; 75.00% patients were having one ear affliction. Maximum number of patients, i.e. 85.71%, had Karnakandu, followed by 82.14% patients had Karnashula and Karnapratinaha, 78.57% patients had Karnasrava, 71.43% patients had Badhirya, and 57.14% patients had Karnanada as presenting symptom. The otoscopic signs i.e. fungal mass had been observed in maximum number of patients, i.e. 100.00% followed by 38.46% patients had tenderness and 19.23% patients had erythema.

Total effect of therapy

In Group-A, patients showed 90.91% relief in Karnashula followed by Karnakandu (90.00%), Karnasrava (88.24%), Karnanaha (72.72%), Karnanada (68.75%) and Badhirya (34.78%), statistically all the results were found highly significant at the level of P<0.001 except Badhirya (<0.01) which is significant. Patients showed 100% relief in tenderness and erythema followed by 77.27% relief in fungal mass. The results were statistically highly significant in all the signs at the level of P<0.001 [Table 1].

Table 1

Effect of therapy in Group-A on signs and symptoms in 13 patients of Karnasrava (otomycosis)

In Group-B, patients showed 100.00% relief in Karnasrava, Karnashula, and Karnanada followed by 90.69% relief in Karnakandu, 81.81% relief in Karnanaha, and 66.66% relief in Badhirya [Table 2]. The results were found highly significant at the level of P<0.001 in all the symptoms except Badhirya where it was significant at the level of P<0.01. Patients showed 100% relief in tenderness and erythema. The results were statistically highly significant in all the Otoscopic signs at the level of P<0.001. Patients showed 83.33% relief in fungal mass. The result was significant at the level of P<0.01 [Table 2].

Table 2

Effect of therapy in Group-B on signs and symptoms in 13 patients of Karnasrava (otomycosis)

46.16% cure was found in Group A, while 69% cure in Group B. Over all effect of the therapy is depicted at Figure 1.

Figure 1

Overall effect of therapy

Discussion

Karnasrava is explained as a symptom and as a disease in Ayurveda. While describing the etiological factors of Karnasrava, Aacharya have given special emphasis to Jalanimanjjana and Karnakanduyana which is commonly found in otomycosis. In Samprapti of Karnasrava, Aacharya Sushruta has mentioned that Avarana of Vata by other Dosha is the chief culprit for initiation of the pathology.[9]

By assessing the symptoms, it can be said that Kapha Aavrita Vata Dosha is responsible for the manifestation of clinical features like discharge, pain, itching, etc. of otomycosis. In otomycosis, mainly watery and purulent type of discharge is present which shows the condition of Paka. While removing the fungal mass, ulceration of external auditory canal is likely to happen. Considering these points otomycosis can also be treated in the line of Dushtavrana. Regarding Sadhyasadhyata, Acharya has mentioned that Vrana situated in Twaka and Mamsa and Vrana lies in Karna is Sukhasadhya.[10] In Uttaratantra, Acharya Sushruta considered Karnasrava itself as Sadhyaroga.

The mode of action of the drug under trial can be understood on the basis of inherent properties of the drugs.

Rasa of all the drugs are Katu and Tikta; Guna are Ruksha, Laghu, Tikshna; Snigdha and Ushna Veerya and mainly Kapha-Vata Shaamaka properties.

With the properties of Katu and Tikta Rasa, it will encounter Vata and Kapha Dosha. The Katu Rasa removes obstruction, dilates the passages, and relieves Kapha.[11]

Tikta Rasa induces cleanness, dryness, and keenness. With Krimihara and Puyashoshanakara properties it will help to remove ear debris, fungal mass, discharge, and reduces itching. Tikta Rasa contains Shodhana property which can help to open channels and clean the wound, ultimately leads healing process. Ruksha Guna is having Shoshana Shakti which can absorb the discharge in auditory canal and pacifies the Kapha Dosha. Laghu Guna having Lekhana and Ropana properties which can help in healing of wound. Tikshna Guna is Shighrakari which means it starts action very quickly and will encounter Vata and Kapha Dosha. Due to Ushna Veerya it will encounter Vata Dosha and Gati of Vata gets normalized (Anulomana). This way it will work on functional mechanism. Another benefit of Ushna Veerya is that it enhances local as well as general metabolism. Because of this, it will correct Dhatuposhana Krama and ultimately it will leads to production of Uttama Twaka and Mamsa Dhatu.

Conclusion

On the basis of clinical features, otomycosis can be correlated with Karnasrava having predominance of Vata and Kapha Dosha. For Karnapurana Taila should be prepared till the stage of Kharapaka. Karnapurana is very effective local procedure in Karnagata Roga. Sufficient amount (approximately 10-15 drops) of Arka Taila should be instilled (Karnapurana) to get expected results. Arka Taila has not shown any side effect so it should be used. Both the drugs (Arka Taila and Clotrimazole) are equally effective to treat the disease Karnasrava (Otomycosis). Arka Taila Karnapurana for duration of 15 days (minimum 6-10 days) is sufficient for the treatment of the disease Karnasrava (Otomycosis), provided proper Pathyapathya should be followed. As Vrana is always present in patient of Karnasrava-otomycosis, Dushtavrana Chikitsa can be adopted in treatment of Karnasrava. Shashti Upakrama can be incorporated in treatment of Karnasrava (otomycosis) in further study on a larger sample.