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| ORIGINAL ARTICLE |
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| Year : 2021 | Volume
: 15
| Issue : 4 | Page : 249-254 |
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A Randomized Clinical Trial of Karnapichu with Gandhaka Taila, Karnadhupana, and Rasnadi Guggulu in the Management of Karnasrava W. S. R. to Chronic Suppurative Otitis Media
Meena Nagar, Gulab Chand Pamnani, Rajendra Kumar Soni
Department of Shalakya Tantra, National Institute of Ayurveda, Jaipur, Rajasthan, India
| Date of Submission | 19-Sep-2020 |
| Date of Decision | 16-Apr-2021 |
| Date of Acceptance | 19-Jul-2021 |
| Date of Web Publication | 16-Dec-2021 |
Correspondence Address:
Gulab Chand Pamnani
Department of Shalakya Tantra, National Institute of Ayurveda, Jaipur - 302 002, Rajasthan
India
 Source of Support: None, Conflict of Interest: None
DOI: 10.4103/joa.joa_117_20
Background: Chronic suppurative otitis media (C.S.O.M.) is a chronic inflammation of the middle ear, which is the result of an initial episode of acute otitis media and characterized by the recurrent discharge from the middle ear through a tympanic perforation. In Ayurveda, C.S.O.M. can be correlated with Karnasrava. According to Acharya Sushruta, Karnasrava is "discharge of pus from a Vata affected ear which may result from a head injury or due to immersion in water or else due to suppuration or bursting of an abscess." In modern science, most of the approaches for the treatment of C.S.O.M. have been surgical, which are often expensive, complicated, and do not provide satisfactory hearing improvement; also these are inaccessible in many developing countries. Considering all these points, there is a need to search for an effective, preventive, and safe treatment. Objective: The objective of this study is to evaluate the efficacy of Karnapichu and Karnadhupana along with Rasnadi Guggulu on Karnasrava. Materials and Methods: A total of 30 patients with signs and symptoms of Karnasrava (C.S.O.M.) were registered and randomly divided into two groups: Group A: 15 patients were treated with Gandhaka Taila Karnapichu (8–16 drops) along with Rasnadi Guggulu orally for 30 days and Group B: 15 patients were treated with Karnadhupana locally and Rasnadi Guggulu orally for 30 days. Results: Both the groups showed highly significant results in the subjective parameters and nonsignificant results in the objective parameters of Karnasrava. Conclusion: Gandhaka Taila Karnapichu, Rasnadi Guggulu, and Karnadhupana are effective in the management of Karnasrava (C.S.O.M.).
Keywords: Chronic Suppurative Otitis Media, Gandhaka Taila, Karnadhupana, Karnapichu, Karnasrava, Rasnadi Guggulu
How to cite this article:
Nagar M, Pamnani GC, Soni RK. A Randomized Clinical Trial of Karnapichu with Gandhaka Taila, Karnadhupana, and Rasnadi Guggulu in the Management of Karnasrava W. S. R. to Chronic Suppurative Otitis Media. J Ayurveda 2021;15:249-54 |
How to cite this URL:
Nagar M, Pamnani GC, Soni RK. A Randomized Clinical Trial of Karnapichu with Gandhaka Taila, Karnadhupana, and Rasnadi Guggulu in the Management of Karnasrava W. S. R. to Chronic Suppurative Otitis Media. J Ayurveda [serial online] 2021 [cited 2022 Jan 27];15:249-54. Available from: http://www.journayu.in/text.asp?2021/15/4/249/332597 |
| Introduction | |  |
Ears are prone to 28 different kinds of ailments (according to Sushruta), and Karnasrava is one among them.[1] Acharya Charaka included Karnasrava as a symptom under the four types of Karnarogas due to vitiation of different Doshas.[2] Acharya Vagbhata has not described Karnasrava separately. Karnasrava means flow, oozing, dropping, exudates or discharge through the ear. According to Sushruta, Karnasrava is "discharge of pus from a Vata affected ear may result from a head injury or due to immersion in water or else due to suppuration or bursting of an abscess."[3] Other causes such as Avashyaya (dew), Pratishyaya (common cold), Mithya yogena Shasstrasya, Mithyayogena Shabdasya also included by Sushruta. According to Acharya Sushruta, Karnasrava is treated by Shirovirechana (Nasya), Dhupana, Purana, Pramarjana, Dhavana, and oral drug therapy, etc.[4]
We can correlate Karnasrava in modern science with chronic suppurative otitis media (C.S.O.M.). C.S.O.M. is a chronic inflammation of the middle ear, which is the result of an initial episode of acute otitis media and characterized by recurrent discharge from the middle ear through a tympanic perforation.[5] C.S.O.M. is one of the most common complaints encountered in the clinical practice of ENT medicine. A history of at least 2 weeks of persistent ear discharge should alert to the problem.
Histologically, C.S.O.M. is defined as irreversible mucosal changes within the middle ear cleft. More prone groups for C.S.O.M. are lower socioeconomic status (due to poor nutrition and lack of health education), upper respiratory tract infections, swimming and diving, traumatic perforations of the tympanic membrane, infections of tonsils and adenoids, chronic rhinitis and sinusitis, nasal allergy, cleft palate, exanthematous fevers (such as measles, diphtheria, and whooping cough), living in crowded conditions, history of multiple episodes of acute otitis media, etc.[6] In modern science, patients of C.S.O.M. are treated with instillation of topical antiseptics or antibiotics daily after meticulous aural toileting for at least 2 weeks, intravenous antibiotics, anti-pseudomonal drugs, etc.; patients having intra-cranial and extra-cranial infections are more appropriately treated with surgery.[7]
According to the WHO, most of the prevalence studies, observational surveys, and sampling strata have shown that the global burden of illness from C.S.O.M. involves 65–330 million individuals, out of which 60% (39–200 million) suffer from significant hearing impairment, C.S.O.M. accounts for approximate 28,000 deaths due to complications and a disease burden of over 2 million disability-adjusted life years.[8] It is one of the types of hearing loss which can be prevented, mostly in developing countries.
In modern science, most of the approaches for the treatment of C.S.O.M. have been surgical, which are often expensive, complicated and do not provide satisfactory hearing improvement; also these are inaccessible in many developing countries.
Considering all these points, there is a need to search for an effective, preventive, and safe treatment. In Ayurveda, a number of formulations are described under Karnaroga Chikitsa. Hence, there is definitely a scope of research for a better solution in the disease of Karnasrava. Here, a comparative study was designed for the comparison of the efficacy of Gandhaka Taila Karnapichu locally with Rasnadi Guggulu orally and Karnadhupana locally with Rasnadi Guggulu orally.
Aims and objectives
- To study Karnasrava in both Ayurveda and modern parlance
- To evaluate the efficacy of Karnapichu and Karnadhupana along with Rasnadi Guggulu on Karnasrava
- To compare the effectiveness of trial drugs.
| Materials and Methods | | |
- Literary materials: A critical review of relevant literature in Ayurveda textbooks, previous research papers and thesis, different medical books, and journals regarding Karnasrava and C.S.O.M. were carried out
- Clinical materials: (1) Sampling method: Computer generated randomization was adopted. (2) Selection of patients: The study was conducted on 30 clinically diagnosed patients of Karnasrava from OPD/IPD of Shalakya Tantra department NIA, Jaipur
- Ethical clearance: Institutional Ethics Committee (IEC) approval was taken before initiation of research work vide letter number IEC/ACA/2018/58, dated 11/05/2018
- CTRI number: CTRI/2019/06/019914
- The inclusion criteria were as follows: Patient having specific signs and symptoms of Karnasrava (C.S.O.M.) on Ayurvedic and modern parameters were selected
- The exclusion criteria were as follows: (1) Age below 8 years and above 60 years. (2) Systemic diseases such as uncontrolled diabetes mellitus, meningitis, tuberculosis, and hypertension. (3) History of long-term intake of ototoxic drugs. (4) Pregnant women. (5) C.S.O.M. with complications such as acute mastoiditis, petrositis, facial paralysis, adenoids, tonsillitis, and labyrinthitis
- Laboratory investigation: Following investigations were done for the assessment of the condition and to exclude any other pathology of the patients - C.B.C., E.S.R., F.B.S., ear swab culture, and sensitivity
- Grouping of patients: A total of 30 patients with sign and symptoms of Karnasrava (C.S.O.M.) were registered and randomly divided into two groups irrespective of their age, sex, occupation, religion, socioeconomic status, etc. Group A: 15 patients were treated with Gandhaka Taila Karnapichu (8–16 drops) along with Rasnadi Guggulu orally for 30 days. Group B: 15 patients were treated with Karnadhupana locally and Rasnadi Guggulu orally for 30 days
- Dose and duration:-
- Dose for Rasnadi Guggulu: Adult dose: 500 mg twice daily orally (after food); Children dose: 250 mg twice daily orally (after food); Anupana: Lukewarm water
- Duration: 30 days
- Dose for Karnapichu with Gandhaka Taila: 8–16 drops twice a day
- Duration: 30 days
- Karnadhupana with Karnadhupana Dravyas: Twice a day
- Duration: 30 days
- Follow-up: Patients were followed for 1 month at the interval of 15 days, after completion of the trial
- Assessment criteria: The results of the clinical trial were assessed on the basis of the observations obtained from the clinical features and laboratory findings for which the following parameters were adopted: Subjective: The following signs and symptoms were examined during the course of therapy: (1) Karnasrava (presence/absence of discharge) (2) Badhirya (Conductive hearing loss) (3) Karnakandu (itching in the ear)
- Objective: The following objective criteria were assessed before and after trial. (1) Otoscopy. (2) Ear swab culture and sensitivity. (3) Pure-tone audiometry
| Observations | | |
- Maximum number of patients (32.35%) have belonged to the age group of 21–30 years followed by 23.52% patients in 31–40 years' age group, female (50%), Hindu religion (76.47%), having education up to graduate level (29.41%), followed by (29.41%) patients with primary level education, homemakers, and students (32.35%each) followed by (17.64%) of patients from labor class, 52.94% from lower middle class followed by the middle class (44.11%). Majority of the patients (52.94%) were found to be addicted to tea/coffee, sedentary lifestyle (55.88%), no family history of Karnasrava (88.23%), and all the patients had previous treatment history for Karnasrava
- A maximum number of patients had Vata-Kapha Prakriti (58.82%) while 26.47% patients had Pitta-Kapha Prakriti, 52.94% of patients were of Rajasika Prakriti followed by 35.29% of patients having Satvika Prakriti and Madhyama Vikriti, Samhanana, Pramana, Satmaya, Satva, Abhyavharana Aahara Shakti, Jarana Shakti, Vyayama Shakti, and Vaya, i.e., 100%, 94.11%, 91.17%, 100%, 88.23%, 82.35%, 82.35%, 58.82%, and 82.35%, respectively
- In the present study, it was observed that the majority of patients (67.64%) were having Pratishyaya as Nidana followed by 17.64% of patients having Jalakrida Nidana Sevana
- It was observed that maximum number of patients (41.17%) were found infected with Staphylococcus aureus, 20.58% of patients had no growth, 17.64% of patients infected with Coagulase-negative staphylococcus, 11.76% of patients were infected with Pseudomonas, 5.88% of patients were infected with Escherichia coli, 2.94% of patients were infected with Enterococcus bacterial infection. Data show that Staphylococcus infection is expected in the patients of Karnasrava
- It was observed that the maximum number of patients (100%) had gradual onset of Karnasrava, with unilateral ear involvement (76.46%), intermittent Srava (100%), moderate quantity (70.58%), yellow color (91.97%), and purulent discharge (55.88%) and without the smell (55.88%)
- A maximum number of patients had unilateral (61.76%) ear involvement in Karnakandu, intermittent Karnakandu (79.41%), moderately severe Karnakandu (73.52%), and 44.11% of patients had Karnakandu in the noon
- Majority of patients (38.23%) had no hearing loss, 47.05% of patients had mild hearing loss, and 61.76% of patients had gradual onset of Badhirya.
| Discussion | | |
Discussion on trial drugs with their probable mode of action
Rasnadi Guggulu
Rasnadi Guggulu has six contents: Rasna, Amrita, Eranda, Devadaru, and Shunthi one part each and Guggulu five parts.[9] Most of the drugs of Rasnadi Guggulu have Rasayana, Kasa-Shwasahara, Vedanasthapana, Shulaprashmana, Shothahara, Balya, Vranashodhana, Vranaropana, Krimighna, Deepana, and Pachana properties. In Karnasrava, Pratishyaya is main Nidana which is Vatadominant, and here most of the drugs have Kapha-Vata Shamaka properties, Amrita and Guggulu have Tridosha Shamaka properties, which helps in Samprapti Vighatana. Here all the drugs have Ushna Virya which enhances local as well as general metabolism of the body. It helps in drying up the Srava and facilitates quick action of the drug. Most of the drugs have antioxidant and nervine tonic properties which help in the prevention of cochlear damage or further Badhirya. In Rasnadi Guggulu, Guggulu is the main content (5parts or 50%). According to Ayurveda in all types and conditions of Vidradhi, Guggulu is very useful with suitable decoction, according to Dosha.[10] When it takes orally, it is very beneficial in healing chronic ulcer (Nadivrana) and Kushtha.[11] It is useful in Avrita-Vata. It is proved that Guggulu has excellent analgesic effect. It has Rasayana properties which help in Jara-Vyadhinashanam. It is established that Guggulu and Guduchi have an immune-modulatory effect, which helps in boosting up the immune system and prevention of repeated infections. Considering all these points, it is very beneficial in Karnasrava, because in later stage Karnasrava becomes just like Nadivrana and it has the involvement of AvritaVata.
Gandhaka Taila
It contains Shudha Gandhaka, Shudha Manahshila, Haridra as Kalka Dravyas and Dhattura Patra Swarasa as Drava Dravya and Sarshapa Taila as base.[12] Taila prepared by TailapakaVidhi up to Kharapaka state as indicated for Karnapichu. Most of the drugs of Gandhaka Taila have Krimighna, Jantughna, Kandughna, Kushthaghna, Lekhana, Vishaghna, Vedanasthapana, Vranashodhana, Vranaropana, Varnyakara, Putihara, and Shulaprashmana properties. Due to these properties, the Gandhaka Taila relieves local pain and do Kleda-Achushana which helps in alleviating Karnasrava and regeneration of tympanic membrane. Ushna Virya helps in quick action of drug. Gandhaka and Manahashila both are Yogavahi and enhance the effect of drug. Sarshapa Taila is strong insecticidal, which helps in the elimination of local infection. Ruksha Guna of Dhatura helps in drying up the Srava.
Probable mode of action of Karnadhupana
Acharya Sushruta has mentioned the concept of Dhupana and mentioned Dhupana Dravyas such as Guggulu, Aguru, Sarjarasa, Ghrita, Nimba, Vacha, Sarshapa, and Lavana.[13] Most of Karnadhupana Dravyas have Kushthagna, Kandughna, Vedanasthapana, Vataghna, Vranashodhana, Vranaropana, Putihara, Shothahara, Lekhana, Shulaprashamana, and Krimihara properties. According to Acharyas, Dhupana Dravyas have Rakshoghna properties means Dravyas which protects us from hazardous influences. In this procedure, ear is exposed to reducing pain, cleanliness, and mitigation of exudates. Dhupana Dravyas possess analgesic, antifungal, anti-inflammatory, antimicrobial, Shulahara, Vata Shamaka, and astringent properties, thus purifying the wound and external auditory canal. Acharya Sushruta has mentioned that Dhupana is very useful in Karnarogas.[14] These Dhupana Dravyas have the properties which can break the chronicity of disease Karnasrava.
| Results of Therapeutic Trial | | |
The pattern of clinical improvement in various subjective and objective parameters was recorded and measured statistically in two groups, by using Graph-Pad software version 8 and results were graded as mentioned below:
- Extremely significant (ES): P <0.0001
- Very significant (VS): P = 0.001–0.01
- Significant (S): P = 0.01–0.05
- Nonsignificant (NS): P >0.05
Analysis of the effect of therapy on sign and symptoms of Group A [Table 1] | Table 1: Effect of therapy on sign and symptoms of Karnasrava in Group A
Click here to view |
- Statistically, extremely significant (<0.0001) results were found in Karnasrava quantity (67%) and Karnakandu (69.92%)
- Statistically very significant (<0.01) results were found in Karnasrava consistency (43%)
- Statistically not significant (>0.05) results were found in Badhirya (24.52%)
- Statistically not significant (>0.05) results were found in objective parameters, pure-tone audiometry (6.45%), T. M. Assessment (8.75%), swab culture, and sensitivity (36.98%).
Analysis of effect of therapy on sign and symptoms of Group B [Table 2] | Table 2: Effect of therapy on sign and symptoms of Karnasrava in Group B
Click here to view |
- Statistically extremely significant (<0.0001) results were found in Karnakandu (65.41%)
- Statistically very significant (<0.01) results were found in Karnasrava quantity (26.54%) and Karnasrava consistency (46.23%)
- Statistically not significant (>0.05) results were found in Badhirya (16.66%)
- Statistically not significant (>0.05) results were found in objective parameters, pure tone audiometry (17.69%), T. M. assessment (11.56%), swab culture, and sensitivity (30.30%).
Comparison of effect of therapy on sign and symptoms of in Group A and Group B [Table 3] | Table 3: Comparison of effect of therapy on sign and symptoms of in Group A and Group B
Click here to view |
- There was no significant difference between the groups except the quantity of Karnasrava where the effect was significantly more in Group B.
| Conclusion | | |
- In Karnasrava, duration of disease is very important, if we manage Karnasrava in the early state, we can prevent further complications and bone eroding process such as Chlolesteotoma. Nidana Parivarjana is the first line of treatment for any disease, so we should try to avoid Nidanas such as Pratishyaya, Jalakrida, and Karnakandu. The use of any sharp object in ear to relieve itching should be avoided. The ear canal should be cleaned before the application of Karnadhupana and Karnapichu. Pathya Palan is very important in disease Karnasrava to avoid recurrence
- It was observed that in subjective parameters like Karnasrava quantity, Group A showed 67% relief (E. S.) and Group B showed 26.54% relief (E. S.). It indicates that Gandhaka Taila Karnapichu is more effective in Karnasrava quantity
- It was observed that in subjective parameters like Karnasrava consistency, Group A showed 43% relief (V. S.) and Group B showed 46.23% relief (V. S.). It indicates that Karnadhupana is slightly more effective in Karnasrava consistency
- It was observed that in subjective parameters such as Karnakandu, Group A showed 69.92% relief (E. S.) and Group B showed 65.41% relief (E. S.). It indicates that Gandhaka Taila Karnapichu is slightly more effective in Karnakandu
- In subjective parameters like Badhirya, Group A showed 24.52% relief (N. S.) and Group B showed 16.66% relief (N. S.). It indicates that Gandhaka Taila Karnapichu is slightly more effective in Badhirya
- It was observed that in objective parameters such as pure tone audiometry, Group A showed 6.45% change (N. S.) and Group B showed 17.69% change (N. S.), in T. M. assessment, Group A showed 8.75% change (N. S.) and Group B showed 11.56% change (N. S.), it indicates that Karnadhupana is slightly more effective in objective parameters of pure tone audiometry and TM assessment
- In swab culture and sensitivity, Group A showed 36.98% change and Group B showed 30.33% change, it indicates that Gandhaka Taila Karnapichu is more effective in the objective parameters of swab culture and sensitivity
- Statistically, there was difference between efficacies of both groups.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3]
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