E-ISSN:2456-3110

Research Article

Devadarvadi Ghrita

Journal of Ayurveda and Integrated Medical Sciences

2024 Volume 9 Number 11 NOVEMBER
Publisherwww.maharshicharaka.in

A randomized controlled clinical study to evaluate the efficacy of Nasya with Devadarvadi Ghrita in the management of Ardhavabhedaka

Patil PS1*, Sudarshan A2, Guruprasad3, Vidyashree4
DOI:10.21760/jaims.9.11.4

1* Pooja S Patil, Post Graduate Scholar, Department of Panchakarma, Muniyal Institute of Ayurveda Medical Sciences, Manipal, Karnataka, India.

2 Sudarshan A, Professor and HOD, Department of Panchakarma, Muniyal Institute of Ayurveda Medical Sciences, Manipal, Karnataka, India.

3 Guruprasad, Professor, Department of Panchakarma, Muniyal Institute of Ayurveda Medical Sciences, Manipal, Karnataka, India.

4 Vidyashree, Assistant Professor, Department of Panchakarma, Muniyal Institute of Ayurveda Medical Sciences, Manipal, Karnataka, India.

Background: Ardhavabhedaka is one among the Shirorogas explained by our Acharyas in which Shoola is experienced in Ardha Bhaga of the Shiras. Ardhavabhedaka can be scientifically correlated with Migraine due to its cardinal features of Half sided headache. Ardhavabhedaka if not treated it can cause Netra and Shotra Nasha, hence an early treatment is essential. Devadarvadi Ghrita Nasya is indicated in Ardhavabhedaka by Acharya Harita, therefore, this study was conducted to access its efficacy.

Objective: To compare the efficacy of Devadarvadi ghrita Nasya and Shadbindu taila Nasya in the management of Ardhavabedaka.

Methodology: In this single-blind study, 40 patients exhibiting classical features of Ardhavabhedaka, who met the inclusion criteria, were divided into two groups of 20 patients each for analysis. Group A was treated with Devadarvadi Ghrita Nasya, while Group B was treated with Shadbindu Taila Nasya for 7 days, followed by a follow-up assessment on the 14th day, after which statistical analysis was conducted.

Result: Although there was no statistical significance observed, both the groups demonstrated clinical significance in reducing the frequency, duration, severity of headache and giddiness.

Conclusion: Devadarvadi Ghrita Nasya showed better results than Shadbindu Taila in the management of Ardhavabhedaka.

Keywords: Ardhavabhedaka, Devadarvadi Ghrita, Nasya, Migraine

Corresponding Author How to Cite this Article To Browse
Pooja S Patil, Post Graduate Scholar, Department of Panchakarma, Muniyal Institute of Ayurveda Medical Sciences, Manipal, Karnataka, India.
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Patil PS, Sudarshan A, Guruprasad, Vidyashree, A randomized controlled clinical study to evaluate the efficacy of Nasya with Devadarvadi Ghrita in the management of Ardhavabhedaka. J Ayu Int Med Sci. 2024;9(11):23-28.
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https://jaims.in/jaims/article/view/3775

Manuscript Received Review Round 1 Review Round 2 Review Round 3 Accepted
2024-10-14 2024-10-26 2024-11-06 2024-11-16 2024-11-26
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None Nil Yes 12.32

© 2024by Patil PS, Sudarshan A, Guruprasad, Vidyashreeand 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].

Download PDFBack To ArticleIntroductionMaterials and
Methods
ObservationsResultsDiscussionConclusionReferences

Introduction

Ayurveda is a science of life which promotes positive health, prevents diseases, and helps in achieving long life. The main of the Ayurveda is to maintain health in healthy persons and to cure the diseases in diseased person. Shiras is considered as Uttamanga,[1] as it is the seat for Panchagyanendriya, it is one among the Trimarma's and it is one among Dashapranayatanas. In Ayurveda different Acharyas have mentioned different number of Shiroragas in which Ardhavabhedaka is one among them. Ardhavabhedaka as the name indicates it produces Shoola in half part of the head. As explained by Acharya Charaka, Shastraarani Nibha Shoola is experienced in Manya, Bhru, Akshi, Karna, Shankha Pradesha etc,[2] this is mainly caused by Vata dosha or in association with Kapha Dosha,[3] symptoms reoccur in the interval of 10 or 15 days without any relevant cause. Ardhavabhedaka can be correlated with Migraine, as both the disease showcases unilateral headache (Ardhamastaka Vedana). Migraine is a chronic neurological disease characterised by recurrent, moderate to severe headache typically affecting one half of the head, is pulsating in nature and lasts from 4 to 72 hours. Associated symptoms may include nausea, vomiting and sensitivity to light, sound, or smell. The pain is generally made worse by physical activity.[4] Migraine is one of the common causes of recurrent headache. According to IHS, Migraine constitutes 16% of the primary headache and affects 10-20% of the general population. It is three times more common in women than men. Ayurveda classics has an elaborate description of the disease, including its treatment. Acharya Charaka has mentioned the treatment as intake of 4 types of Sneha, Shirovirechana, Kayavirechana, Upanaha, Shirobasti.[5] Nasya or Shirovirechana is one of the Panchakarma procedure in which drugs or medicated liquids like Sneha, Swarasa etc. is administered through the nose. Nasya is especially described for the treatment of Urdhwa Jatrugata Vikaras.[6] Nasa is said to be the door of the Shiras. Medicine administered through the nose, spreads into different parts of Shiras and helps in the evacuation of the Doshas, thereby pacifying the diseases. Devadarvadi Ghrita is one of the formulations mentioned in Harita Samhita and this is direct indicated for Nasya in Ardhavabhedaka.[7]

Hence keeping in view of all the above references and increasing incidence, a clinical study has been chosen to assess the efficacy of Devadarvadi Ghrita Nasya in the management of Ardhavabhedaka.

Materials and Methods

Study design: Single blind randomized controlled clinical study.

Methodology: 40 patients suffering from classical features of Ardhavabhedaka fulfilling the inclusion criteria were taken up for the study, from the OPD and IPD of Panchakarma and Shalakya department of our college hospital, and they were divided into two groups each comprising of 20 patients, Informed consent was obtained from eligible patients before the initiation of treatment. Approval was taken from the institutional committee (IEC/MIAMA/PK/02/22) prior to the patient’s enrolment.

Preparation of medicine: After proper identification, the drugs were collected from local area and Devadarvadi Ghrita was prepared as per Sneha Paka Vidhi in the department of Rasashatra and Bhaisajya Kalpana department of our college.

Table 1: Ingredients of Devadarvadi Ghrita

NameBotanical nameFamilyPart usedQuantity
DevadaruCedrus deodaraPinaceaeBark1 part
RajaniCurcuma longaZingiberaceaeRhizome1 part
ShatiHedychium spicatumZingiberaceaeRhizome1 part
PushkaramoolaInula racemosaAsteraceaeRoot1 part
KutajaHolarrhena antidycentricaApocynaceaeSeeds1 part
MaghadiPiper longumPiperaceaeFruit1 part
KushtaSaussuria lappaAsteraceaeRoot1 part
LodhraSymplocus racemosaSymplocaceaeBark1 part
ChavikaPiper chabaPiperaceaeRoot1 part
YavasaAlhagi camelorumFabaceaeWhole plant1 part
MustaCyperus rotundusCyperaceaeTubers1 part
GugguluCommiphora mukulBurseraceaeResin1/8th part
ShuntiZingiber officinaleZingiberaceaeRhizome
HaritakiTerminalia chebulaCombretaceaeFruit
VibhitakiTerminalia bellericaCombretaceaeFruit
AmalakiEmblilca officinalisCombretaceaeFruit
Saindhava---
Go Ghrita---1 part
Go Ksheera---4 parts
Go Dhadi---4 parts
Khanda Sharkara---Q.S

Inclusion criteria

  • Patients having the classical signs and symptoms of Ardhavabhedaka.
  • Patients of either sex, irrespective of caste and religion.
  • Patients aged between 18-60 years.
  • Patients fit for Nasya karma.

Exclusion Criteria

  • Diagnosed patients having Shiroroga other than Ardhavabhedaka like Suryavarta
  • Diagnosed patients with any inflammatory diseases of Nose, Ear, Eye.
  • Diagnosed Patients having history of head trauma.
  • Diagnosed Patients of Hypertension, cervical spondylitis, meningitis and refractive errors.
  • Pregnant women and Lactating women.
  • Patients who are unfit for Nasya.

Intervention

Group A was administered with Devadarvadi Ghrita Nasya and Group B was administered with Shadbindu Taila Nasya. Treatment duration was 7 days. Post treatment follow up was on 14th day. The dose for Nasya is 6 Bindu in each nostril.

Procedure of Nasya

Purva Karma: Sthanika Abhyanga and Swedana was done over Urdhwajatru Pradesha, then patient was made to line in supine position with head slightly extended.

Pradhana Karma: 6 Bindu of lukewarm medicine was instilled in both the nostrils.

Paschat Karma: Dhoomapana with Haridra Dhooma Varti followed by Kavala with Sukoshna Jala was done.

Assessment criteria: A detailed proforma was prepared for the assessment criteria and the data obtained was analysed statistically.

1. of location of pain
2. Frequency of headache
3. Duration of headache
4. Severity of headache
5. Giddiness

Statistical Analysis

Data collection was followed by entry in Excel, and analysis was conducted using Graphpad InStat v3.0. Quantitative data were presented as mean and standard deviation, while qualitative data were shown as numbers and percentages. Normality was assessed with the Shapiro-Wilk test. Comparisons for quantitative data utilized unpaired T-test or Mann-Whitney U test, and qualitative data were analysed using the Chi-square test. A p-value of less than 0.05 was considered statistically significant.

Observations

The study revealed that the highest incidence occurred in the 18-30 age group, comprising 40% of cases, followed by 35% in the 31-40 age group across both groups. Notably, most patients were female (67.5%), primarily consisting of housewives and students. Additionally, 40% of cases exhibited a chronicity of 6 months to 1 year.

Results

Table 2: Percentage change in treatment outcomes between before treatment, after treatment and at follow-up.

Group ABTATAFP - value (Repeated measures ANOVA)
Number of locations of pain3.15 ± 0.71.15 ± 0.91 ± 1<0.01
Frequency of headache1.95 ± 1.10.9 ± 0.50.7 ± 0.5<0.01
Duration of headache2.65 ± 1.11.05 ± 0.70.85 ± 0.7<0.01
Severity of headache2.7 ± 0.91.1 ±0.70.8 ± 0.4<0.01
Giddiness0.1 ± 0.300<0.01

Table 3: Percentage change in treatment outcomes between before treatment, after treatment and at follow-up.

Group BBTATAFP- value (Repeated measures ANOVA)
Number of locations of pain3.2 ± 0.71.5 ± 0.71.4 ± 0.8<0.01
Frequency of headache1.9 ± 1.041.1 ± 0.51.05 ± 0.6<0.01
Duration of headache2.55 ± 0.91.3 ± 0.71.25 ± 0.7<0.01
Severity of headache3 ± 0.71.3 ± 0.61.2 ± 0.7<0.01
Giddiness0.05 ± 0.200<0.01

jaims_3775_00.JPG
Graph 1: Percentage improvement in the treatment outcome between Before treatment and at follow up.

Discussion

The disease Ardhavabhedaka is one among the 11 types of Shirorogas considered by our Acharyas. The causes of Ardhavabhedaka are excessive intake of Ruksha Padarthas, Adhyashana, Purva Vata Sevana, Atimaithuna (excessive coitus), Vegadharna (suppressing of natural urges), Atishrama (excessive work) in which pain is appreciable in one half of Shiras, Shanka, Bru, Lalata, and in Karna Pradesha. The attacks of Ardhavabhedaka will be once in three days, once in fifteen days and once in a month as per classics. Migraine is a syndrome of episodic recurrent headaches, more often unilteral, which is associated with nausea, vomiting, photophobia or phonophobia. It is more common in women than in men and a family history is present in more than 60% of cases. Approximately 80% of patients with migraine have migraine without aura and 15-20% has migraine with aura. By above-explained definition we can corelate disease Ardhavabhedaka with Migraine explained in western system of medicine.

Effect of treatment on number of locations of pain

Group A showed a 63.5% reduction after treatment and 68.25% reduction at follow up, while Group B had a 53.8% reduction after Treatment and at follow up 56.25% reduction.

Effect of treatment on frequency of Headache

Group A saw a 53.8% decrease after the treatment and 64.1% decrease at follow up while compared to Group B had 42.1% after treatment and 44.7% at follow up.

Effect of treatment on duration of Headache

Group A showed a 60.4% reduction after treatment and 67.9% reduction at follow up while compared to group B had 49.1% reduction after treatment and 50.9% reduction at follow up.

Effect of treatment of severity of Headache

Group A showed 59.2% decrease after treatment and 70.4% decrease at follow up while Group B had 56.7% decrease after treatment and 60% decrease at follow up.

Most of the Dravyas like Guggulu, Devadaru, Haridra, Shati and Pushkaramoola present in Devadarvadi Ghrita are having Vedanasthapana and Shoolahara property making them effective in alleviating Shirashoola. The frequency, duration, and severity of headache are significantly reduced owing to the Vatahara properties of the Dravyas present in Devadarvadhi Ghrita. These ingredients help to balance the aggravated Vata Dosha, which is often the root cause of Ardhavabhedaka. Ghrita as a Medhya, calms the mind, reduce stress and promote sleep there my easing headache.

Effect of treatment on Giddiness

In the present study 3 patients out of 40 presented with giddiness, all of them got complete relief (100% relief in the symptom.) The Pitta - Shamaka Dravyas presents in Devadarvadhi Ghrita, such as Yavasa, Lodhra, Amalaki, Godugdha, Go-Ghrita, effectively help to reduce Giddiness by balancing excess Pitta Dosha in the body.

Probable mode of action of Devadarvadi Ghrita Nasya in Ardhavabhedaka
Effect on Dosha

  • Devadarvadhi Ghrita contains Tridoshahara properties, making it highly effective in balancing all the Tridoshas - Vata, Pitta and Kapha and maintaining their equilibrium.
  • Ghrita and Godugdha due to its Madhuara Rasa and Sheeta Veerya effectively helps in pacifying vitiated Vata and Pitta Doshas.

Effect on Dushya: Devadaru and Haridra possessing Raktaprasadaka property that may normalise vitiated Rakta Dhatu.

Effect on Srotas: Saindhava Lavana effectively promotes the Kapha Vilayana and Kapha Chedana of accumulated Kapha Dosha, thereby clearing Srotorodha.


Teekshna Guna of drugs present in Devadarvadi Ghrita such as Shati, Pushkaramoola, Shunti Kushta, enables the formulation to deeply penetrate the Sookshma Srotas, thereby it expels the vitiated Doshas.

Mode of Action of Nasya Karma

Acharya Charaka, while explaining the indication for Nasya in Siddhisthana, has emphasized that the Nasya drug usually acts through absorption by the Shringataka Marma. After absorption of the drug, it acts on the diseases of Urdhwajatru and the Doshas are expelled from the Shira Pradesha. The absorption of the drugs is carried out in three media they are, through blood circulation, through pooling into the venous sinuses of the brain via the inferior ophthalmic veins, passes the BBB and gets absorbed into CSF. Besides the small emissary veins entering the brain’s cavernous sinuses, a pair of venous branches from the alae nasi drains into the facial vein. These ophthalmic veins, however, also drain into the cavernous sinuses, and both the facial and ophthalmic veins lack valves. This increases the likelihood of blood flow from the facial vein to the cavernous sinus when the head is lowered. The nasal cavity directly opens into the frontal, maxillary, and sphenoidal sinuses, with a continuous epithelial lining throughout. Temporary retention of the drug in the nasopharynx and suction can cause the drug to enter these air sinuses, which are richly supplied with blood vessels leading to the brain and meninges through natural openings in the bones. This pathway therefore enhances drug transport. Drugs administered here reach the paranasal sinuses where the ophthalmic and other veins are dispersed. The sphenoidal sinuses are close to intracranial structures, suggesting an as-yet-undetected route between the air and cavernous sinuses. The mention of Shringataka here appears reasonable, as Marsha Nasya therapy helps clear vitiated Vata and Kapha Doshas and can aid in treating Ardhavabhedaka.

Conclusion

Based on concepts, analysis and clinical observations made in this study, the following conclusions are drawn; Ardhavabhedaka is a Shoola Pradhana Vyadhi characterised by feeling of severe pain like Shastra Arani Nibha in half part of the head involving Manya, Bhru, Shankha, Karna, Akshi and Lalata.

Currently, the incidence of Ardhavabhedaka is notably high, largely driven by the rise in stress and disrupted sleep patterns prevalent in modern life. Nasya Karma is given prime importance in the management of Shiroroga. Since Nasya Dravya due to its Tridoshahara properties, helps in balancing Tridosha leading to its significant effectiveness in treatment. In relieving Frequency, duration, Severity of Headache and Giddiness both the group showed significant results. Devadarvadi Ghrita Nasya is more effective than Shadbindu Taila Nasya in the management of Ardhavabhedaka.

References

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2. Trikamji J, Charaka Samhita of Agnivesha, Chakrapani Datta’s Ayurveda Deepika, Sans, Siddhisthana, Chaukhambha Orientalia, Varansi, 2021, Pg -721, Pp-738.

3. Trikamji J, Charaka Samhita of Agnivesha, Chakrapani Datta’s Ayurveda Deepika, Sans, Siddhisthana, Chaukhambha Orientalia, Varansi, 2021, Pg -721, Pp-738.

4. wikipedia.org/ Migraine Headache, www.ihs-headache.org

5. Trikamji J, Charaka Samhita of Agnivesha, Chakrapani Datta’s Ayurveda Deepika, Sans, Siddhisthana, Chaukhambha Orientalia, Varansi, 2021, Pg -721, Pp-738.

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7. Pandey Jaymini, Harita Samhita of Nirmala, Hindi, Tritiyasthana, 41/5-8, Choukhambha Visvabharati, Varanasi, 2010, Pg-445.

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