E-ISSN:2456-3110

Research Article

Madhumeha

Journal of Ayurveda and Integrated Medical Sciences

2022 Volume 7 Number 3 April
Publisherwww.maharshicharaka.in

Bhudhatryadi Yoga in Madhumeha (diabetes mellitus type 2): An open label single arm clinical study

Sharma S.1*, Jadhav L.2
DOI: http://dx.doi.org/10.21760/jaims.7.3.1

1* Sakshi Sharma, Post Graduate Scholar, Department of Kayachikitsa, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan, Karnataka, India.

2 Lakshmiprasad L Jadhav, Professor, Department of Kayachikitsa, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan, Karnataka, India.

Background: Diabetes mellitus is a metabolic disorder characterized by persistent hyperglycemia either due to less production of insulin or resistance of insulin receptors. Globally 463 million individuals are affected by type 2 diabetes & 77 million belong to India. India is deemed as the world's capital of diabetes. It can be correlated to Madhumeha. Bhudhatryadi Yoga is mentioned for the treatment of Prameha. Bhudhatryadi Yoga has Tikta Rasa, Laghu-Ruksha Guna, Sheeta Veerya. Katu Rasa of Maricha is Deepana and Pachana. It does Kleda Shoshana, Meda Shoshana and Kapha Harana. It removes Sroto Rodha and thereby helps in alleviating Kapha Prakopa. The effect of methanol extract of aerial parts of Bhumyamlaki has α–amylase & α–glucosidase enzyme inhibitory properties. α –amylase & α – glucosidase aid the production of glucose from the catabolism of starches and oligosaccharides. Methods: 28 registered subjects, 23 completed the course of intervention. They were administered with Bhudhatryadi Yoga orally 12 gm per day (6 gm twice daily before food) with Anupana of lukewarm water for a period of 30 days. Blood and urine glucose test was done on 1ST, 7TH and 30th from the day one of study initiation. For Statistical analysis subjective parameters were assessed by Cochran’s Q test followed by McNemar test and objective parameters were assessed by Repeated Measures Anova and Paired T Test. Results: There was statistically significant improvement observed in the signs and Symptoms of Madhumeha with blood and urine glucose levels. (p<0.05). Interpretation and Conclusion: Bhudhatryadi Yoga is effective in management of Madhumeha

Keywords: Madhumeha, Diabetes Mellitus, Bhudhatryadi Yoga, Ayurveda

Corresponding Author How to Cite this Article To Browse
Sakshi Sharma, Post Graduate Scholar, Department of Kayachikitsa, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan, Karnataka, India.
Email: 		Sakshi Sharma, Lakshmiprasad L Jadhav, Bhudhatryadi Yoga in Madhumeha (diabetes mellitus type 2): An open label single arm clinical study. J Ayu Int Med Sci. 2022;7(3):1-6.
Available From
https://jaims.in/jaims/article/view/1787

Manuscript Received Review Round 1 Review Round 2 Review Round 3 Accepted
2022-03-01 2022-03-03 2022-03-10 2022-03-17 2022-03-24
Conflict of Interest Funding Ethical Approval Plagiarism X-checker Note
Nil Nil Yes 16%

© 2022by Sakshi Sharma, Lakshmiprasad L Jadhavand 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].

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Sharma S et al: Bhudhatryadi Yoga in Madhumeha (diabetes mellitus type 2)

Introduction

Diabetes is a major health issue; nearly half a billion people are living with diabetes worldwide. It is one of the fastest growing global health emergencies of 21st century. In 2019 it is estimated that 463 million people have diabetes and this number will reach 578 million by 2030 and 700 million by 2045.[1] Diabetes mellitus is one of the most common systemic disease and it occurs when pancreas does not produce enough insulin or when the body cannot effectively use that insulin.[2] Type 2 diabetes is the most common type of diabetes, accounting around 90 % of all diabetes worldwide. India is deemed as the world's capital of diabetes.[3]

Prameha when left untreated leads to Madhumeha. It is also known as Ojomeha. Madhumeha  arises either by Dhatukshaya or Avarana.[4] Atisevana of Guru, Snigdha Guna, Amla , Lavana rasa , Naveena Annapana, Ati Nidra, Avyayama lead to Dushti of Kapha, Pitta, Meda, Mamsa thereby causing obstruction to Vata. This obstructed Vata expels Oja through Basti causing Madhumeha. It produces Lakshana like Prabhootamutrata, Madhurasyata, Kshudhadhikya, Pipaasaadhikya, Kara-Padadaha, Kara-Padasuptata, Mukha-Talu-Kantashosha, Alasya, Atisweda, Dourgandhya.[5] Diabetes mellitus clinically presents with polyuria, polydipsia, polyphagia, paresthesia. The symptoms of Diabetes Mellitus are found to be similar with of Madhumeha. Bhudhatryadi Yoga is mentioned in the treatment of Prameha.[6] It has two ingredients, Bhudhatri  and Maricha. Bhudhatri has Tikta, Kashaya Rasa, Sheeta Veerya & Pitta Kapha Hara properties[7]  Maricha has Katu Rasa, Ushna Veerya, Deepana & Kapha Vata Hara properties.[8] Hexane extract of Bhudhatri is found to have α- amylase inhibitory properties which shows hypoglycemic effect  by inhibiting starch converts into glucose.[9] Piperine, one of the phytoconstituent is found to  have antidiabetic action.[10]

Material and Methods

Source of data: Outpatient department of Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan.

Method of collection of data

Screening: Subjects were screened using screening form and recruited subject’s data   

was collected using specially prepared case report form (CRF) by incorporating subjective, objective parameters of Madhumeha (Diabetes mellitus Type 2).

Diagnostic Criteria: Among screened subjects, Madhumeha (diabetes mellitus) was diagnosed on the basis of Signs   and   symptoms   of   Madhumeha   like   Prabhootamutrata,  Kshudhadhikya Pipaasaadhikya, Kara-Padadaha, Kara-Padasuptata, Mukha-Talu-Kantashosha , ADA (American Diabetes Association) diagnostic criteria of diabetes was taken into consideration.

Inclusion Criteria: Fresh cases or diagnosed cases of Diabetes mellitus Type -2 on Ayurveda treatment,

Subjects of either gender of age between 30-70yrs, Type II Diabetes mellitus with Fasting Blood glucose: >126mg/dl, or Post Prandial, Blood glucose >200mg/dl or HbA1c >6.5[11] Subjects who were willing to participate in study and ready to sign the informed consent were taken into study.

Exclusion Criteria: Subjects with other systemic conditions like cardiac illness, impaired kidney and hepatic function, carcinoma, AIDS, Lactating and pregnant women, Subjects with Diabetes mellitus Type 2 on Insulin, History of uncontrolled Diabetes were excluded.

Ethical clearance and CTRI registration

Ethics clearance certificate was obtained from Institutional Ethics Committee.

Trial was registered on www.ctri.gov.in (12/2019/029702 dated 13th December ,2019)

Study design: The study was an open label, single arm, prospective clinical trial in madhumeha (diabetes mellitus) (n=23) selected using convenience (non random) sampling technique with pre and post design conducted in tertiary Ayurveda hospital attached to Ayurveda medical college located in district headquarters in southern India.

Dosage and Drug Administration

Drug: Bhudhatryadi yoga

Dosage: 6gm BD

Route of administration: Oral

Time of administration: BD Before food

Anupana: Ushna jala


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Sharma S et al: Bhudhatryadi Yoga in Madhumeha (diabetes mellitus type 2)

Duration: 30 days

Observation

In the present study total 50 subjects were screened, out of which 28 subjects were registered for the study, among them 23 subjects completed the study. Among 28 subjects maximum (n=10) were from the age group of 51-60 years and predominance of Females (n=15). 14 subjects were from middle class group and majority of them (n=19) had sedentary life style. Diet wise distribution showed maximum (n=21) had non veg diet. Considerable number of subjects (n=20) were not doing Vyayama (Exercise), maximum number of subjects (n=15) had family history.

Results

23 subjects were administered with Bhudhatryadi yoga in a dose of 6gm BD Before food along with Ushna Jala for a period of one month.

Mc nemar test was run on subjective parameters and has shown significant improvement in symptoms like Praboota Mootrata , Kshudadikya, Karapada Daha. Results are placed at

Paired t Test was run on objective parameters like FBS, PPBS, FUS and PPUS and has shown significant improvements.

Discussion

Effect of Bhudhatryadi Yoga on Prabhootamootrata

There was statistically significant improvement in Prabhootamootrata after treatment with p value <.05. Prabhuta Mootrata is Mootravahasrotas, Medovahasrotasvikriti Lakshana. It can be understood as increase in Kapha, Abadhamedas, Kledamsha. Bhudhatryadi Yoga has Tikta-Kashaya Rasa and Rukshaguna which are Kledo-Upashoshaka and helps in pacifying this symptom.

Effect of on Trishnadhikya and Mukhatalushosha

There was statistically significant improvement in Trishnaadhikya after treatment with p value <.05. Bhudhatryadi Yoga showed significant result in Udakavhasrotasdusti due to its Tikta, Madhura, Kashaya Rasa and Trishnanigrahana property of Bhumyamlaki.

Effect of on Kshudhadhikya

There was statistically significant improvement in the Kshudhaadhikya after treatment with p value <.05. Kshudhaadhikya occurs due to Avarana of Abadhamedas over Koshtaagni which causes vitiation of Vata and leads to Kshudhaadhikya.

Maricha has Katu Rasa, Ushnaveerya, Deepana Pachana and Srotoshodhaka properties which acts at level of Dhatwaagni, leads to proper formation of rasa dhatu and removes the Avarna of Abadhamedas at level of Koshtaagni and thus specify the symptom.

Effect of Bhudhatryadi Yoga on Biochemical parameters

Effect of Bhudhatryadi Yoga in Fasting blood sugar

A repeated measures ANOVA determined that FBS mean scores were statistically significant with p < 0.05. Post hoc tests using the Bonferroni correction 0.016 revealed that treatment elicited decrease in Fasting Blood Glucose from 1st day – 30th day of treatment.

Effect of Bhudhatryadi yoga in Post prandial blood glucose

A repeated measure ANOVA determined that PPBS mean scores were statistically significant with p < 0.05.

Post hoc tests using the Bonferroni correction 0.016 revealed that treatment elicited decrease in Fasting Blood Glucose between 1st day -7th day, 7th – 30th day and 1st day – 30th day with p <.016.

Result on Fasting Urine Glucose

There was statistically significant difference in FUS with Friedman’s test at p < 0.05.

Post hoc with Wilcoxon signed rank test showed there was statistically significant difference in FUS between 1st day -7th day, 7th – 30th day and 1st day – 30th day with p <.016.

Result on Post Prandial Urine Glucose

There was statistically significant difference in PPUS with Friedman’s test at p< 0.05.

Post hoc with Wilcoxon signed rank test showed there was statistically significant difference in PPUS between before treatment and after treatment with p<0.016.


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Sharma S et al: Bhudhatryadi Yoga in Madhumeha (diabetes mellitus type 2)

Discussion on Probable Mode of Action of Drug

Bhudhatri has Tikta, Kashaya, Laghu, Ruksha Guna acts as Pitta-KaphaShamaka, Grahi, Kleda-Medoupashoshaka. Sheetha Virya, Madhura Vipaka of Bhudhatri is Kapha-Pithashamaka. Maricha is Katu Rasa Pradhana which has Deepana- Pachana, property. Katu Rasa has Sneha-Meda-Kledaupashoshana property. Katu Rasa also causes Srotoshodhanam. Hexane extract of Bhudhatri has α–amylase & α–glucosidase inhibitory properties. α–amylase & α–glucosidase aid the production of glucose from the catabolism of starches and oligosaccharides.[12] Phytoconstituent of Maricha, Piperine is found to have antidiabetic action.[13]

The present study showed significant reduction in both subjective and objective parameters of Madhumeha.

Conclusion

Bhudhatryadi Yoga in a dose of 6gm BD Before food along with Ushna Jala for a period of one month has shown better results in subjective parameters like Praboota Mootrata, Kshudadikya, Trishna Adhikya and Karapada Daha and also in objective parameters like FBS, PPBS, FUS and PPUS.

Table 1: Showing effect of Bhudhatryadi yoga on subjective parameters by applying Friedman’s test

Parameter Value N Cochran’s Q P value Remark
Present Absent
Prabhoota Mootrata BT 19 4 23 17.160   <.05 S
Prabhoota Mootrata 7TH day 17 6
Prabhoota Mootrata 30th day 8 15
Mukhatalukanthashosha BT 2 21        
Mukhatalukanthashosha 7th day 2 21 23 2.0 >.05 NS
Mukhatalukanthashosha 30th day 1 22        
Kshudha Adhikya BT 9 14        
Kshudha Adhikya 7TH day 6 17 23 10.57 <.05 S
Kshudha Adhikya 30 day 2 21        
Trishna Adhikya BT 8 15        
Trishna Adhikya 7th day 8 15 23 12.00 <.05 S
Trishna Adhikya 30th day 2 21        
Karapada Tala Daha BT 3 20        
Karapada Tala Daha 7th day 3 20 23 2 >.05 NS
Karapada Tala Daha 2 21        
Karapada Suptata BT 3 20        
Karapada Suptata 7th day 3 20 23 2 >.05 NS
Karapada Suptata 30th day 2 21        

Table 2: Pair wise comparison of PPBS at different interval of treatment

Pairs P Value  Days Mean Difference SE 95% Confidence   interval   for difference Remark
Lower bound Upper bound
BT .053 7 Days 21.696 10.594 -.274 43.665 S
7 Days .520 30 Days 3.739 5.725 -8.12807 15.611 NS
AT 040 30 Days 25.435 11.660 1.25410 49.61 S

Table 3: Pair wise comparison of PPBS at different interval of treatment

Pairs Days Mean Difference SE P Value 95% Confidence   interval   for difference Remark
Lower bound Upper bound
BT 7 Days 47.95 13.1 .001 20.65 75.25 S
7 Days 30 Days 5.9565 6.6 .383 -7.9 19.8 NS
AT 30 Days 53.91 15.9 .003 20.79 87.03 S

Table 4: Wilcoxon Signed rank test showing effect of Bhudhatryadi Yoga on FUS

Intervals N Sum of Ranks Z P Remarks
NR PR T Total
BT - 7Th Day 7 0 16 23 28 -2.6 <0.016 S
7Th Day - 30TH Day 8 0 15 23 36 -2.8 <0.016 S
BT - 30Th Day 15 0 8 23 120 -3.8 <0.016 S

Table 5: Wilcoxon Signed rank test showing effect of Bhudhatryadi Yoga on PPUS

Intervals N Sum of Ranks Z P Remarks
NR PR T Total
BT-7TH Day 16 0 7 23 136 -4.0 <0.016 S
7TH  Day – 30TH Day 4 0 19 23 10 -2.0 >0.016 NS
BT-30TH Day 19 0 4 23 190 -4.26 <0.016 s

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