A randomized controlled clinical study of Amrutprabha Gutika in the management of Kaphaja Kasa

Himanshi; Susheel Shetty; K Kiran

doi:10.21760/jaims.9.11.3

A randomized controlled clinical study of Amrutprabha Gutika in the management of Kaphaja Kasa

Himanshi^1*, Shetty S², K Kiran³

DOI:10.21760/jaims.9.11.3

^1* Himanshi, Post Graduate Scholar, Dept of PG Studies in Kayachikitsa, Alva's Ayurveda Medical College Moodubidire, Karnataka, India.

² Susheel Shetty, Professor and HOD, Dept of PG Studies in Kayachikitsa, Alva's Ayurveda Medical College Moodubidire, Karnataka, India.

³ K Kiran, Assistant Professor, Dept of PG Studies in Kayachikitsa, Alva's Ayurveda Medical College Moodubidire, Karnataka, India.

Background: Kaphaja Kasa is one of the five types of Kasa, where Kasa Vega is associated with Prabhuta-Snigda-Ghana-Kapha Nisteevana. The aim of the study was to assess the efficacy of two Ayurvedic formulations, Amrutprabha Gutika which was unexplored Aushadha Yoga explained in Yogachintamani, Gutikadhikara and Lavangadi Gutika explained in Vaidhyajivanam, Swasakasa Chikitsa in the management of Kaphaja Kasa.

Materials and Methods: 60 patients fulfilling the Diagnostic and Inclusion criteria were selected for a Single Blind Comparative study, they were randomly allocated into 2 equal groups A & B, Group A and Group B received Amrutprabha Gutika and Lavangadi Gutika respectively in the dosage of 500mg, one tablet, twice daily, after food with Ushnodaka (lukewarm water) for 30 days, Assessment was done at baseline i.e.; 0th day, 16th day, after treatment on 31st day and after follow up on 46th day.

Results: While comparing both the drugs clinically, Amrutprabha Gutika and Lavangadi Gutika showed effective results in Kaphaja Kasa. On statistically comparison within the groups, both the groups showed significant effect in Kasavega, Kapha Nisteevana, Aasyamadhuryata, Aruchi, Peenasa, Angagourava, TC, DC, ESR, AEC in both the groups.

Conclusion: On statistical comparison between the two groups there is neither significant difference between Amrutprabha Gutika nor Amrutprabha Gutika is better than Lavangadi Gutika.

Keywords: Amrutprabha Gutika, Lavangadi Gutika, Kaphaja Kasa

Corresponding Author	How to Cite this Article	To Browse
Himanshi, Post Graduate Scholar, Dept of PG Studies in Kayachikitsa, Alva's Ayurveda Medical College Moodubidire, , Karnataka, India. Email:	Himanshi, Shetty S, K Kiran, A randomized controlled clinical study of Amrutprabha Gutika in the management of Kaphaja Kasa. J Ayu Int Med Sci. 2024;9(11):15-22. Available From https://jaims.in/jaims/article/view/3854

Introduction

Kaphaja Kasa is one of the five types of Kasa mentioned in Ayurvedic Classics. It is a Pranavaha Srotodusti, where Vata and Kapha are the two key pathological factors involved in the Samprapti of Kaphaja Kasa.^[1] The Lakshanas of Kaphaja Kasa are Bahulam, Madhuram, Snigdha, Ghana Kapha Nisteeva-na, Mandagni, Aruchi, Chardi, Peenasa, Utklesha, Gourava, Lomaharsha, Aasyamadhuryata, Kleda.^[2] Based on Lakshanas of Kaphaja Kasa, it can be compared with Chronic Bronchitis.^[3]

Chronic Bronchitis is a clinical condition characterized by productive cough due to excessive mucus secretion in the bronchial tree, not caused by local broncho-pulmonary disease, on most of the days, for at least 3 months of a year, for at least 2 consecutive years. ^[4] The estimated prevalence of chronic bronchitis is 5.0% in India.^[5] Cough (kasa) is the most common sign of all respiratory illness. If neglected, it may lead to other illnesses like Shwasa, Kshaya, Chardi and Swarabheda etc.^[6] Therefore, it should be treated carefully in the beginning. According to Ayurvedic literature, the treatment lines for Snehana, Swedana, Shodhana, Dhoopana, Shamana, and Rasayana are administered in the following order to create a holistic solution for Kasa. The Shamana treatment line includes oral medication administration, which is thought to be more convenient to administer than Shodhana. Numerous studies on the Shamana treatment, as recommended by Ayurveda, have been conducted, and their therapeutic value has been established. Many more herbal combinations are described in Ayurveda, and it is unknown how effective these combinations are as treatments for Kasa.

The medicines which have Katu Rasa, Ushna Veerya, Kaphavatahara, Agni Deepana, Kapha Nissaraka and Vatanulomana properties are effective in the management of Kaphaja Kasa. Amrutprabha Gutika is mentioned in Yogachintamani under Gutikadhikara. The ingredients are Akarkara, Saindhava, Chitraka, Shunti, Amalaki, Maricha, Haritaki, Lavanga, Matulunga Swarasa.^[7] Most of the ingredients are having Katu Rasa, Ushna Veerya and Kapha- Vata Shamaka properties. Depending upon its Rasapanchaka and other properties, this formulation is taken as a Trial drug.

Lavangadi Gutika is mentioned in Vaidhyajivanam in Swasakasa Chikitsa. The ingredients are Lavanga, Maricha, Vibhitaki Twak, Khadira sara, Babula Kwatha.^[8]

Most of the ingredients are having Katu, Tikta Rasa and Ushna Veerya and Kapha-Vata Shamaka. All the drugs in Lavangadi Gutika are having Kasaghna properties.^[9] Considering its properties and previous research supporting its effectiveness on Kaphaja kasa, this has been taken as a Standard drug.

The present study was planned to evaluate and compare the efficacy of Amrutprabha Gutika and Lavangadi Gutika in the management of Kaphaja Kasa.

Aim of the Study

To explore the therapeutic effects of Amrutprabha Gutika in the management of Kaphaja Kasa.

Objectives of the Study

1. To evaluate the efficacy of Amrutprabha Gutika in the management of Kaphaja Kasa.
2. To compare the efficacy of Amrutprabha Gutika with Lavangadi Gutika in the management of Kaphaja Kasa.

Materials and Methods

Sample source: A minimum of 60 patients attending the OPD and IPD of Alva’s Ayurveda Medical college and Hospital, Moodubidire, Medical camps and other referrals diagnosed as Kaphaja kasa and fulfilling the inclusion criteria were selected. Data was collected on a detailed case proforma designed for the study.

Study design - Parallel group comparative clinical study.
Blinding - Single blind
Allocation - Random allocation
Method of sampling - Randomization Software
Groups - 2 groups

Group A: Amrutprabha Gutika

Group B: Lavangadi Gutika

Sample size - 30 patients in each group
Total sample size - 60 patients

Diagnostic criteria:Patients were diagnosed based on Kasa (Cough) with Sandra and Bahula Kapha Nishteevana (Spitting of thick phlegm in large quantity) with or without following symptoms.

Aasyamadhuryata (Mouth sweetness)
Aruchi (Anorexia)
Peenasa (Running nose)
Gourava (Chest heaviness)
Utklesha (Nausea)

Inclusion criteria

Patients fulfilling the diagnostic criteria of Kaphaja Kasa.
Patients having age between 16 to 70 years, inclusive of both ages.
Patients willing to participate in the study and ready to sign informed consent form.

Exclusion criteria

Patients having Productive cough with complications like: Tuberculosis, Emphysema or Pneumonia etc.
Patients with any other systemic and metabolic disorders which may interfere the study will be excluded.
Patients suffering from Acute conditions (Acute Bronchitis, COVID19)
Pregnant and Lactating women will be excluded.
Patients undergoing steroid therapy.

Subjective parameters Primary

Kasa (Cough)
Sandra-Bahula Kapha Nishteevana (Spitting of thick phlegm in large quantity)

Secondary

Aasyamadhuryata (Mouth sweetness)
Aruchi (Anorexia)
Peenasa (Running nose)
Angagourava (Chest heaviness)
Utklesha (Nausea)

Objective parameters

Intervention

The patients fulfilling the criteria for inclusion are randomly assigned into 2 groups.

Table 1: Intervention

Groups	Group A	Group B
Sample size	30 patients	30 patients
Study Drug	Amrutprabha Gutika	Lavangadi Gutika
Dose	500mg	500mg
Anupana	Ushnodaka (lukewarm water)	Ushnodaka (lukewarm water)
Time	Two times a day, after food	Two times a day, after food
Duration	30 days	30 days

Observation Period

The patients will be assessed clinically before treatment on 0^th day and during treatment, on 16th day, after treatment on 31st day and on 46th day.

Follow Up

Follow up of the patient was done on 46^th day, after the intervention period.

Investigations

Hb, TC, DC, ESR, AEC.
Chest X-ray to rule out other conditions.

Observations and Results

Table 2: Observation of 60 patients

Characteristics	Predominance	Percentage
Age	21-25 years	23.3%
Gender	Male	55%
Religion	Hindu	78.3%
Marital status	Married	55%
Occupation	Students	50%
Socioeconomic status	Middle	66.6%
Diet	Mixed	73.3%
Prakriti	Vata-kapha	58.3%
Satmya	Madhyama	73.3%
Satwa	Madhyama	78.3%
Abhyavarharana Shakti	Avara	55%
Jarana Shakti	Avara	58.3%

Statistics

Statistical test applied

Descriptive Statistics was applied to each parameter first. Wilcoxon Signed Rank Test and Paired ‘t’ Test was performed for analyzing the efficacy of medicines before and after trial within the group. Mann-Whitney Rank Sum Test and Unpaired ‘t’ Test was performed for comparing both the groups. The summarized form of Statistical Analysis is presented below.

Table 3: Effectiveness of the medicine before and after the trial on Subjective Parameters

Assessment criteria	Group	Median score		WSRT value	p value	Remarks
Assessment criteria	Group	BT	AT	WSRT value	p value	Remarks
Kasa vega	Group A	2	0	435	<0.001	SS
Kasa vega	Group B	2	0	435	<0.001	SS
Kpaha nisteevana	Group A	2	0	465	<0.001	SS
Kpaha nisteevana	Group B	2	0	465	<0.001	SS
Aasyamadhuryata	Group A	1	0	78	<0.001	SS
Aasyamadhuryata	Group B	1	0	105	<0.001	SS
Aruchi	Group A	1	0	231	<0.001	SS
Aruchi	Group B	0.5	0	91	<0.001	SS
Peenasa	Group A	0.5	0	120	<0.001	SS
Peenasa	Group B	1	0	105	<0.001	SS
Angagourava	Group A	1	0	21	0.031	SS
Angagourava	Group B	1	0	36	0.008	SS
Utklesha	Group A	0	0	10	0.125	NS
Utklesha	Group B	0	0	10	0.125	NS

Table 4: Effectiveness of the medicine before and after the trial on Objective Parameters

Criteria		Group	Mean Score		Mean Diff.	S.D. (±)		S.E.M. (±)		Paired ‘t’ test
Criteria		Group	BT	AT	Mean Diff.	BT	AT	BT	AT	t value	p value
TC		Group A	8060	6483.3	1576.6	942.3	966.7	172	176.4	9.355	<0.001
TC		Group B	8486.6	6936.6	1550	949.3	305.2	173.3	305.2	6.382	<0.001
ESR		Group A	10.033	7.733	2.3	1.938	1.437	0.354	0.262	6.173	<0.001
ESR		Group B	10.133	8.067	2.067	1.479	8.067	0.270	0.239	7.878	<0.001
AEC		Group A	204.167	192.700	11.467	59.657	58.834	10.892	10.742	9.985	<0.001
AEC		Group B	189.767	178.533	11.233	62.540	60.627	11.418	11.069	9.912	<0.001
DC DC	N	Group A	56.4	55.567	0.833	1.404	1.135	0.256	0.207	4.475	<0.001
	N	Group B	56.633	55.467	1.166	1.474	1.167	0.269	0.213	5.722	<0.001
	L	Group A	39.033	37.567	1.467	1.956	2.112	0.357	0.386	6.279	<0.001
	L	Group B	39.7	38.533	1.167	1.841	2.177	0.336	0.398	5.178	<0.001
	E	Group A	2.533	1.7	0.833	0.730	0.877	0.133	0.160	7.047	<0.001
	E	Group B	2.233	1.533	0.7	0.679	0.819	0.124	0.150	7.167	<0.001
	M	Group A	1.633	1	0.633	0.809	0.983	0.148	0.179	6.238	<0.001
	M	Group B	1.967	1.533	0.433	0.809	0.819	0.148	0.150	4.176	<0.001
	B	Group A	0	0	0	0	0	0	0	0	1.000
	B	Group B	0	0	0	0	0	0	0	0	1.000

Table 5: Comparative analysis of the overall effect of the treatments on Subjective Parameters

Assessment criteria	Median value BT-AT		Mann-Whitney Test		Remarks
Assessment criteria	Group A	Group B	t value	p value	Remarks
Kasa Vega	2	2	975	0.377	NS
Kapha Nishteevana	2	2	919	0.953	NS
Aasyamadhuryata	0	0	900	0.830	NS
Aruchi	1	0	1020	0.122	NS
Peenasa	0.5	0	930	0.830	NS
Angagourava	0	0	960	0.509	NS
Utklesha	0	0	930	0.829	NS

Table 6: Comparative analysis of the overall effect of the treatments on Objective Parameters

Criteria		Group	Mean Score BT-AT	Mean Diff.	S.D. (±)	S.E.M(±)	Unpaired ‘t’ Test		Remarks
Criteria		Group	Mean Score BT-AT	Mean Diff.	S.D. (±)	S.E.M(±)	t value	P value	Remarks
TC		Group A	1576.667	290	923.144	168.542	1.2	0.235	NS
TC		Group B	1286.667	290	947.859	173.055	1.2	0.235	NS
ESR		Group A	2.3	0.233	1.601	0.292	0.594	0.555	NS
ESR		Group B	2.067	0.233	1.437	0.262	0.594	0.555	NS
AEC		Group A	11.500	0.267	6.252	1.414	0.166	0.869	NS
AEC		Group B	11.233	0.267	6.207	1.133	0.166	0.869	NS
DC DC	N	Group A	0.833	-0.333	1.020	0.186	-1.207	0.232	NS
	N	Group B	1.167	-0.333	1.117	0.204	-1.207	0.232	NS
	L	Group A	1.467	0.300	1.279	0.234	0.924	0.359	NS
	L	Group B	1.167	0.300	1.234	0.225	0.924	0.359	NS
	E	Group A	0.833	0.133	0.648	0.118	0.869	0.388	NS
	E	Group B	0.700	0.133	0.535	0.097	0.869	0.388	NS
	M	Group A	0.567	0.133	0.504	0.092	0.961	0.340	NS
	M	Group B	0.433	0.133	0.568	0.104	0.961	0.340	NS
	B	Group A	0	0	0	0	0	1.000	NS
	B	Group B	0	0	0	0	0	1.000	NS

Table 7: Percentage wise relief in Subjective and Objective Parameters

Subjective Parameters	Group A (AT)	Group B (AT)
Kasa Vega	84.1%	81.6%
Kapha Nishteevana	90.4%	90%
Aasyamadhuryata	100%	100%
Aruchi	100%	80%
Peenasa	100%	100%
Angagourava	100%	100%
Utklesha	100%	100%
Objective Parameters	Group A (AT)	Group B (AT)
TC	19.5%	18.2%
DC	80.6%	62.7%
ESR	22.9%	20.3%
AEC	5.6%	5.9%

Effect of Therapy

60 patients of Kaphaja Kasa were randomly divided into two groups: Group A and Group B. The effect on Subjective and Objective parameters were analyzed here, percentage wise relief AT compared here respect to BT.

Discussion

In the present study, the effect of Amrutprabha Gutika and Lavangadi Gutika on Primary outcomes Kasa vega and Kapha Nishteevana in Group A and Group B respectively were statistically significant from baseline (0^th day) values While comparing both the Groups statistically insignificant result at p>0.05 was found, indicating both treatments were effective. Other associated symptoms like Asyamadhuryata, Aruchi, Peenasa, Angagourava and Utklesha were present only in some study volunteers at baseline and showed improvement on receiving treatments in both the groups except Utklesha. In Objective parameters TC, AEC, ESR showed statistically significant result at p<0.001 in both the groups after treatment, but DC showed statistically significant result at p<0.001 in both the groups after treatment except Basophils (p=1.000). While comparing both the groups for all subjective and objective parameters showed p>0.05, indicates there is no statistically significant difference in the effects of treatment. Both the Gutikas used in this study are having Kapha-Vata Hara properties, Laghu, Ruksha, Katu, Tikta Rasa Pradhana and Ushna Veerya. which helps in Samprapti Bhagana of Kaphaja Kasa.

Probable mode of action of Amrutprabha Gutika

Amrutprabha Gutika contains Katu Rasa, Ruksha, Tikshna Guna and Ushna Veerya Dravyas. Also, have Kasa hara and Kapha-Vata Hara properties. Due to this Kapha-Vata Hara Doshaghna properties, Kapha Vileyana and Chedana properties of Maricha and Saindhava removes obstructed Kapha from Pranavaha Srotas. Also, Vatanulomana Karma of drug like Haritaki it clears the vitiated Vata and brings back the normal Gati of Vata dosha. Drugs like Akarkara, Chitraka, Shunti, Maricha and Haritaki have Deepana and Pachana properties. So, it does Amapachana and kindles Agni. Amalaki, Maricha and Saindhava are Ruchya. Thus, this formulation is effective in treating Anubandha Lakshana Aruchi.

Maricha is directly indicated in Peenasa, addresses the Anubandha Lakshana Peenasa. Shunti contains Gingerol which helps in smooth muscle relaxation which helps in relieving the congestion.^[10] Piperine has antitussive action, also both piperine^[11] and eugenol^[12] are anti-inflammatory in action. This reduces the inflammation and opens airway. Also, piperine and eugenol are expectorants which help in expulsion of mucus and anti-tussive action of piperine might have helped in suppressing the cough reflex. This combined with broncho-dilatory action and mucolytic-expectorant properties of the drugs mentioned above, might have helped in reducing the symptoms and suppressed the cough reflex. Thus, the combined action resulted in the improvement of main and associated symptoms in Group A.

Probable mode of action of Lavangadi Gutika

Lavangadi Gutika contains Katu, Tikta, Kashaya Rasa Pradhana, Katu Vipaka and Ushna Veerya Dravyas. So, this helps in Kapha-Vata Shamana. Lavanaga because of its Katu Rasa and Tikshna Guna have Kapha Vilayana property. Vibhitaki has Bhedana property that helps in the removal of excess Kapha from Pranavaha Srotas. Vibhitaki has bronchodialtory action also, so it relieves cough reflex.^[13] Lavanga, Maricha, Vibhitaki Twak has Deepana and Pachana properties. So, they do Amapachana and improves Agni. Maricha because of its Katu Rasa, Tikshna Guna. Usna Veerya has Kapha-Vata Hara property. Due to its bronchodilator property Maricha is beneficial in cough and respiratory disorders. The eugenol content in Lavanga is responsible for its bronchodilator and expectorant action. This relieves the symptoms of productive cough reflex. All the drugs in the Lavangadi Gutika have Kasagna property. Thus, the combined action resulted in the improvement of main and associated symptoms in Group B.

Conclusion

In this study two Gutika Yogas; Amrutprabha Gutika and Lavangadi Gutika were considered, their individual therapeutic efficacy in Kaphaja Kasa were evaluated and comparison of their clinical efficacy was done. Clinically, both the Gutikas were effective in the treatment of Kaphaja Kasa. After treatment there was significant effect on all parameters except Utklesha, where statistically insignificant effect was seen within the groups.

On comparison between two groups, it was found that there was no statistically significant difference, with p>0.05. Therefore, both the Gutikas are therapeutically effective in the treatment of Kaphaja kasa individually and on comparison there is no significant difference in their effects.

References

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2. Acharya Agnivesha, Charakasamhita with Ayurveda Deepika Commentry of Chakarpanidatta, edited by Vaidya Jadavji Trikamji Acharya, Published by Chaukamba Surbharati Prakashan, edition: Reprints 2008, Chikitsa Sthana, Chapter 18th /17 to 19, Pg no- 540.

3. Geethakumari S. Critical review of Kaphaja Kasa vis-à-vis Chronic Bronchitis. International Ayurvedic Medical Journal, 2014;2(4):519-527

4. Aspi F Golwalla, Sharukh A Golwalla. Golwalla’s Medicine. 25th Edition, 2017, Pg no- 115-116.

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8. Lolimbaraja, Vaidyajivanam with Dipika Commentary by Rudrabhatta and Edited by Priyavrat Sharma, Published by Chaukhamba Surbharati Prakashan, Edition 2005, Chapter 3rd / 7, Pg no-51.

9. Risin Sugunan & Zenica D’souza: A Comparative Clinical Study to Evaluate the Efficacy of Lavangadi Gutika and Pippalyadi Gutika in Kaphaja Kasa. International Ayurvedic Medical Journal(online) 2021.

10. Liu Y, Liu J, Zhang Y. Research Progress on Chemical Constituents of Zingiber officinale Biomed Res Int. 2019 Dec 20; 2019:5370823. doi: 10.1155/2019/5370823. PMID: 31930125; PMCID: PMC6942719.

11. Kim, Seung-Hyung & Lee, Young-Cheol. (2009). Piperine inhibits eosinophil infiltration and airway hyperresponsiveness by suppressing T cell activity and Th2 cytokine production in the ovalbumin-induced asthma model. The Journal of pharmacy and pharmacology. 61. 353-9. 10.1211/jpp/61.03.0010.

12. Vicidomini, C.; Roviello, V.; Roviello, G.N. Molecular Basis of the Therapeutical Potential of Clove (Syzygium aromaticum L.) and Clues to Its Anti-COVID-19 Utility. Molecules 2021, 26, 1880. https://doi.org/ 10.3390/molecules26071880.

13. Trivedi, V.P., S. Nesamany and V.K. Sharma, 1979. A clinical study of the anti-tussive and anti-asthmatic effects of Vibhitakphal Churna (Terminalia bellerica Roxb.) in the cases of Kasa- Swasa. J. Res. Ayurveda Siddha,3:8.

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Manuscript Received	Review Round 1	Review Round 2	Review Round 3	Accepted
2024-10-16	2024-10-25	2024-11-05	2024-11-15	2024-11-25
Conflict of Interest	Funding	Ethical Approval	Plagiarism X-checker	Note
None	Nil	Yes	12.15

Research Article

Amrutprabha Gutika

Journal of Ayurveda and Integrated Medical Sciences

A randomized controlled clinical study of Amrutprabha Gutika in the management of Kaphaja Kasa

Himanshi^1*, Shetty S², K Kiran³

Introduction

Aim of the Study

Objectives of the Study

Materials and Methods

Observations and Results

Discussion

Conclusion

References

Research Article

Amrutprabha Gutika

Journal of Ayurveda and Integrated Medical Sciences

A randomized controlled clinical study of Amrutprabha Gutika in the management of Kaphaja Kasa

Himanshi1*, Shetty S2, K Kiran3

Introduction

Aim of the Study

Objectives of the Study

Materials and Methods

Observations and Results

Discussion

Conclusion

References

Himanshi^1*, Shetty S², K Kiran³