E-ISSN:2456-3110

Research Article

Diabetic Peripheral Neuropathy

Journal of Ayurveda and Integrated Medical Sciences

2023 Volume 8 Number 12 December
Publisherwww.maharshicharaka.in

Randomised controlled clinical study to evaluate the efficacy of Rajinidvandvadi Kwatha and Nisha Amalaki Kwatha in Prameha Upadrava vis-a-vis Diabetic Peripheral Neuropathy

Krithi NK1*, Shripathi A2, Pramod S3
DOI:10.21760/jaims.8.12.4

1* N K Krithi, Post Graduate Scholar, Department of Kayachikitsa, Muniyal Institute of Ayurveda Medical College and Hospital, Manipal, Karnataka, India.

2 Acharya Shripathi, Professor HOD, Department of Kayachikitsa, Muniyal Institute of Ayurveda Medical Sciences, Manipal, Karnataka, India.

3 Shet Pramod, Associate Professor, Department of Kayachikitsa, Muniyal Institute of Ayurveda Medical Sciences, Manipal, Karnataka, India.

In Ayurveda, although there is no direct correlation for Diabetic Peripheral Neuropathy but the most basic symptoms mentioned under Purvaroopa and Upadrava of Prameha such as Karapada Daha, Karapadasuptata, Toda (Shoola), Harsha Chuchumaya (tingling sensation), Shosha (wasting), Dourbalya (weakness), and Angasaad (malaise) all these resemble the condition of DPN. Pathology behind it is can be studied under Madhumeha Upadrava caused by Avarana Janya Vata Prakopa. And Upadravas are those which develop after the onset of main disease and are dependent on Pradhaana Vyadhi. It will have the same Nidaana, Dosha, and Dushyas as that of the main Disease, though they have Samprapti of its own. When main Disease is managed well, complications will disappear. With this intention, Rajanidvandvadi Kwatha one of the classical Ayurvedic formulations mentioned under Prameha whose all the ingredients are herbal in origin and are known to have Pitta and Vatahara effects but its efficacy has not been documented. Also, Rajani (Nisha) is considered to be Agraoushadha (Drug of choice) in Prameha hence an effort has been made to evaluate the efficacy of Rajanidvandvadi Kwatha in Prameha Upadrava.

Keywords: Prameha Upadrava, Diabetic Peripheral Neuropathy, Rajanidvandvadi Kwatha, Nishamalaki Kwatha.

Corresponding Author How to Cite this Article To Browse
N K Krithi, Post Graduate Scholar, Department of Kayachikitsa, Muniyal Institute of Ayurveda Medical College and Hospital, Manipal, Karnataka, India.
Email:
Krithi NK, Shripathi A, Pramod S, Randomised controlled clinical study to evaluate the efficacy of Rajinidvandvadi Kwatha and Nisha Amalaki Kwatha in Prameha Upadrava vis-a-vis Diabetic Peripheral Neuropathy. J Ayu Int Med Sci. 2023;8(12):20-25.
Available From
https://jaims.in/jaims/article/view/2953

Manuscript Received Review Round 1 Review Round 2 Review Round 3 Accepted
2023-09-05 2023-09-25 2023-10-10 2023-11-01 2023-11-21
Conflict of Interest Funding Ethical Approval Plagiarism X-checker Note
None declared. Nil yes 13.62

© 2023by Krithi NK, Shripathi A, Pramod Sand 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].

Introduction

Diabetic Peripheral Neuropathy (DPN) can cause significant health concerns and decreases the quality of life. If left untreated it may even lead to debilitating consequences like loss of motor activity, foot ulcers, progress to gangrene and amputation. Prevalence[1] of DPN in south India is about 26.1%. Now it is the duty of Vaidya, to try to understand the cause of this disease well enough to design rational therapy to manage it. In Ayurveda, although there is no direct correlation for DPN but the most basic symptoms mentioned under Purvaroopa and Upadrava of Prameha such as Karapada Daha, Karapadasuptata, Toda (Shoola), Harsha/ Chuchumaya (tingling sensation), Shosha (wasting), Dourbalya (weakness), and Angasaad (malaise) all these resemble the condition of DPN.

Pathology behind it is can be studied under Madhumeha Upadrava caused by Avarana Janya Vata Prakopa. And Upadravas are those which develop after the onset of main disease and are dependent on Pradhaana Vyadhi. It will have the same Nidaana, Dosha, and Dushyas as that of the main Disease, though they have Samprapti of its own.

When main Disease is managed well, complications will disappear. With this intention, Rajanidvandvadi Kwatha[2] one of the classical Ayurvedic formulations mentioned under Prameha whose all the ingredients are herbal in origin and are known to have Pitta and Vatahara effects but its efficacy has not been documented. Also, Rajani (Nisha) is considered to be Agraoushadha (Drug of choice) in Prameha hence an effort has been made to evaluate the efficacy of Rajanidvandvadi Kwatha in Prameha Upadrava.

Objectives

1. The present study is intended to understand the aetiopathogenesis of Prameha Upadrava vis-à-vis Diabetic Peripheral Neuropathy.

2. To evaluate the efficacy of Rajanidvandvadi Kwatha in the treatment of Prameha Upadrava vis-à-vis Diabetic Peripheral Neuropathy.

3. To evaluate the efficacy of Nishamalaki Kwatha in the treatment of Prameha Upadrava vis-à-vis Diabetic Peripheral Neuropathy.

4. To compare and ascertain the efficacy of Rajanidvandvadi Kwatha with Nishamalaki Kwatha in the treatment of Prameha Upadrava vis-à-vis Diabetic Peripheral Neuropathy.

Materials and Methods

Study Design: An Open labeled, randomized, comparative, interventional clinical study

Source

Clinical source: Minimum of 40 candidates were selected based on inclusion and exclusion criteria from the OPD and IPD of PG studies in Kayachikitsa of MIAMS, Manipal & medical camps and other referrals

Drug: Rajadvandvadi Kwatha Choorna containing Vidanga, Haridra Daruharidra, Khadira, Usheera, Puga in equal quantity & Nishamalaki Kwatha Choorna was prepared in Rasashala of Muniyal Institute of Medical Science and Hospital, Manipal after collecting the authenticated drugs.

Method of collection of data: A special case proforma was prepared incorporating all the clinical manifestations and assessment criteria including laboratory investigation with minimum 40 patients suffering from Prameha Upadrava was selected as per inclusion and exclusion criteria including detailed history and physical examination.

Diagnostic criteria

History of diabetes with any of the following signs and symptoms

1. Karapada Daha
2. Karapada Suptata
3. Toda
4. Chumchumayana
5. Dourbalya

Inclusion criteria

1. Patient presenting with Pratyamta Lakshana of Prameha Upadrava (DPN) as Karapada Suptata, Karapada Daha, Dourbalya, Chumchumayana, Toda with Fasting Blood Sugar greater than 120 mg/dl and postprandial serum glucose level of greater than 180mg/dl.
2. Diagnosed case of Diabetic Peripheral Neuropathy
3. Patients of either sex will be selected.
4. Age group- 30 to 70 years.


Exclusion criteria

1. Type 1 Diabetes Mellitus patients
2. Gestational diabetes
3. Diabetes Mellitus produced due to other illnesses like Acromegaly, Cushing’s syndrome, pancreatic disorders etc.
4. Autonomic and focal neuropathic patients will be excluded

Investigations

Blood: FBS, PPBS,

Glycosylated haemoglobin (HbA1c) (before treatment)

Urine: FUS {if required}

Assessment criteria

1. Daha
2. Chumachumayana
3. Toda (Shoola)
4. Dourbalya
5. Suptata

Objective criteria[4-6]

1. Toranto clinical neuropathy screening system
2. Young et al criteria diabetic neuropathy symptom score

Intervention

Group A (Study group)

Rajanidvandvadi Kwatha Choorna with lukewarm water will be given 30mins before food twice a day (Morning and Night) for 30 days.

Group B (Control group)

Nisha Amalaki Kwatha Choorna with Lukewarm water will be given 30minutes before food twice a day (Morning and Night) for 30 days

Observations

Among the 40 patients taken for the study 40% of the patients were 50-60 years. 80% patients were males and 20% were females. 90% of the patients belonged to Hindu Religion.

90% of patients were married. Majority of the patient belonged to upper middle class i.e. 90%. 95% of the patients had the dietary habit of taking mixed diet. 60% of the patients had the habit of taking coffee or tea regularly.

60% of the patients had sedentary life style.

Majority of Patients belonged to Vatapitta Prakruti i.e. 60%; 90% patients exhibited Madhyama Sara, 95 % recorded Madhyama Samhanana, 90% patients had Madhyama Pramana, 95% patients having Madhyama Satva and Satmya, 75% of the patients had Avara Vyayama Shakti. 75% had Madhyama Koshtha.

Results

Effect on Daha: there was 49% relief in Group A which is slightly more when compared in Group B (43%). Hence, the result on the effect of treatment on Karapadadaha in Group A was better than Group B (p<0.05).
Effect on Chumchumayana: there was 46% relief in Group B which is slightly more when compared in Group A (42%) (p<0.05). Hence, the result on the effect of treatment on Chumchumayana in Group B was better than Group A.
Effect on Toda: There was 46% relief in Group A which is slightly more when compared in Group B (43%). Hence, the result on the effect of treatment on Toda in Group A was better than Group B (p<0.05).
Effect on Dourbalya: There was 32% relief in Group B which is slightly more when compared in Group A (27%). Hence, the result on the effect of treatment on Dourbalya in Group B was better than Group A.
Effect on Suptata: There was 55% relief in Group B which is slightly more when compared in Group A (52%). Hence, the result on the effect of treatment on Suptata in Group B was better than Group A.
Toranto Score: there was 49% relief in Group A which is slightly more when compared in Group B (35%). Hence, the result on the assessment of treatment through Toranto in Group A was better than Group B.
NDS+ NSS Score: there was 48% relief in Group A which is slightly more when compared in Group B (42%). Hence, the result on the assessment of treatment through NDS+NSS in Group A was better than Group B.
FBS: there was 8% relief in Group B which is slightly more when compared in Group A (4%). Hence, the result on the assessment of treatment through FBS in Group B was better than Group A.
PPBS: there was 12% relief in Group B which is slightly more when compared in Group A (4%).


Table 1: Effect of Rajanidvandvadi Kwatha and Amalaki Kwatha on the symptoms of Prameha Upadrava

DahaMeanBT-AT% ReliefSDSEMMedianZP
BTAT
Group A1.850.950.949BT0.5870.1311.25-4.24<0.001
AT0.6860.1530.25
Group B1.851.050.843BT0.8130.1822-3.77<0.001
AT0.7590.171

ChumchumayanaMeanBT-AT% ReliefSDSEMMedianZP
BTAT
Group A1.81.050.7542BT0.6960.1562-3.87<0.001
AT0.9990.2231
Group B1.951.050.946BT0.510.1142-4.24<0.001
AT0.6050.1351

TodaMeanBT-AT% ReliefSDSEMMedianZP
BTAT
Group A1.8510.8546BT0.6710.152-4.12<0.001
AT0.7950.1781
Group B1.851.050.843BT0.7450.1672-4.000<0.001
AT0.7590.171

DourbalyaMeanBT-AT% ReliefSDSEMMedianZP
BTAT
Group A1.30.950.3527BT1.0810.2421-2.650.016
AT0.9990.2231
Group B1.40.950.4532BT0.9950.2222-3.0000.004
AT0.8870.1981

SuptataMeanBT-AT% ReliefSDSEMMedianZP
BTAT
Group A1.650.80.8552BT0.5870.1312-4.12<0.001
AT0.6160.1381
Group B1.650.750.955BT0.7450.1672-4.243<0.001
AT0.6390.1431

Table 2: Effects of Rajanidvandvadi Kwatha and Amalaki Kwatha on objective criteria

NDS+NSSMeanBT-AT% ReliefSDSEMMedianZP
BTAT
Group A11.0005.7505.2548BT1.2570.28111-3.42<0.001
AT4.0380.9035
Group B11.3006.5004.842BT1.0310.23111-3.733<0.001
AT3.4110.7637

.

FBSMeanBT-AT% ReliefSDSEMMedianZP
BTAT
Group A181.200173.1508.054BT44.1699.877174.5-1.64<0.105
AT26.6175.952177.5
Group B176.800162.70014.18BT41.1109.193177.000-3.175<0.001
AT31.4907.042161.000

PPBSMeanBT-AT% ReliefSDSEMMedianZP
BTAT
Group A269.900259.10010.84BT64.36614.393261.5-1.720.09
AT53.92612.058260.00
Group B276.950244.10032.8512BT68.42815.301293.000-3.400<0.001
AT66.53814.878249.000

TorantoMeanBT-AT% ReliefSDSEMMedianZP
BTAT
Group A10.255.25549BT2.2680.50711-3.83<0.001
AT4.1660.9325
Group B9.86.43.435BT1.8240.40810-3.946<0.001
AT2.6830.6007

Discussion

For the genesis of Prameha Upadrava (DPN), the vitiated Vayu carries away Pitta from its normal site i.e., Mahasrotas leading to Vimargagamana of Vyana Vayu and Pitta which after spreading to the whole body gets Sthana Samsraya in Twacha and produces various features according to Anubandha. If we see the literature of counter part of modern medicine, that gives a similar picture of Diabetic Peripheral Neuropathy. It is supposed that small nutrient vessels (vasa nervosum) which provide nutrition to nerves, become occluded (i.e., Srotorodha occurs, one of the chief causes of Vata-Prakopa).

This leads to deficiency in nutrition of nerves (i.e., deficiency in Tarpana of Snayu-Snayugata, Tarpaka Kapha Kshaya).In a diabetic patient, the usual pathway of glucose metabolism (i.e., via Glucose -6-PO4) becomes depressed and sorbitol pathway becomes predominant. The enzyme sorbitol dehydrogenase acquires more rapid action and as a result, sorbitol and fructose are formed


in excess and become accumulated in tissues which causes damage to nerve tissue and produces axon degeneration which leads to neuropathy.Here axon degeneration and demyelination of nerve sheath may be attributed to Vata Prakopa and Kapha Kshaya. The rapid rate of activity of enzyme sorbitol dehydrogenase may be attributed to Pitta Vriddhi. Normalcy of Vayu is needed for proper healing, growth, and proper maintenance of tissue. Thus, involvement of Tridoshas is apparent in DPN. Rajanidvandvadhi Kwatha is having Tikta, Kashaya Rasa Rasa and Ruksha Guna among which Tikta (bitter) Rasa is said to be “Kleda Upashoshana Meda Shoshana and Kapha Harana while Kashaya (astringent) Rasa to be “Sharira Kledasya Upayokta.” helps in Sthireekarana of Dhatus and also does Kleda, Meda,Vasa, Majja, Lasika, Sweda, Mutra, Pitta, Shleshma, Upashoshana. They are having opposite qualities to that of Kapha and Medas which is the main entity of the pathogenesis of Prameha so these together is helpful in Sthulapramehi & effectively counteract the Samprapti. Most of the ingredients in the formulations are having the properties like Rakthaprasadana, Kushtahara & Vranaropana etc. along with Dahaprashamana, Sheeta Veerya which are helpful for Kara Pada Daha and Kara Pada Supthi.

Here, Peripheral Neuropathies and vasculopathies which are quite in accordance with the late complications of Diabetes Mellitus & for the skin lesions in modern science which are produced in the disease Prameha can be treated. Also, Tikta Rasa removes Sroto Rodha, does Sroto Vivarana & the action of Lekhana might be seen and thereby helps in alleviating Kapha Prakopa. It can be understood in terms of an elevated glycated end product at the cellular level which activates polyol pathway or sorbitol/aldose reductase pathway that decreases the level of glutathione and nitric oxide which is an important vasodilator in turn increase in reactive O2 radicals.This sorbitol cannot cross cell membrane, accumulates & causes osmotic stress on cells by drawing water into cells causing inflammation. Correlating it to Diabetic neuropathy which is a Vatapradhana Tridoshaja Vyadhi having Anubandha with Pitta and Kapha. Where, Kapha, Pitta that are mainly responsible factor for Avarana of Vata, in Madhumeha Samprapti. Vidanga has Nadibalya effect and thus useful when there is neuropathy.

Conclusion

Rajanidvandvadi Kwatha showed significant improvement in the objective criteria’s like Toranto score, NDS+NSS Score after 30 days of treatment in the patients. While Nishamalaki Kwatha had significant improvement in FBS, PPBS. From this study it is evident that Rajanidvandvadi Kwatha has got an added effect in all the subjective parameters like Daha, Toda whereas in Chumchumyana, Dourbalya & Suptata Nishamalaki Kwatha showed better results.

References

1. https://www.ncbi.nlm.nih.gov

2. Yogaratnakar, edited and translated by Dr. Asha Kumari & Dr. (Km.) Premavati Tewari, Chaukhambha Visvabharati

3. R Shashank “Technical monogram diabetic neuropathy” Mumbai SAM and Span Asian Healthcare 2003

4. Peter James Dyck; “Detection, characterization and staging of polyneuropathy, assessed in Diabetes;” muscle and Nerve, 1988; 111:21-32.

5. Dyck et al. “Diagnosis staging and classification of diabetic neuropathy”-Diabetic Neuropathy 1987-36-44.