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Table of Contents
ORIGINAL ARTICLE
Year : 2021  |  Volume : 9  |  Issue : 4  |  Page : 265-271

Efficacy of palliative herbal decoction (Darvyadi Kwatha) with lifestyle modification in the management of prediabetes (Prameha): a single-arm clinical trial


1 Department of Panchakarma, Vijyashree Ayurveda Medical College and Hospital, Jabalpur, India
2 Department of Panchakarma, All India Institute of Ayurveda, New Delhi, India

Date of Submission19-Feb-2021
Date of Decision01-Sep-2021
Date of Acceptance30-Sep-2021
Date of Web Publication29-Dec-2021

Correspondence Address:
Dr. Uttamram Yadav
Department of Panchakarma, Vijyashree Ayurveda Medical College and Hospital, Jabalpur, Madhya Pradesh.
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jism.jism_11_21

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  Abstract 

Background: Prediabetes is a pathological condition that is characterized by an increase in sugar level within the normal limit and a diagnostic range of diabetes mellitus (DM). Timely untreated prediabetes turns into DM within a year and systemic complications occur, such as retinopathy, nephropathy, neuropathy, etc. During later stages of the disease, all systems of the body are affected. The management of prediabetes includes oral hypoglycemic drugs. Based on signs and symptoms, prediabetes can be correlated to the disease Prameha. Aim and Objectives: Evaluate the efficacy of oral administration of Darvyadi Kwatha (~herbal decoction) with lifestyle modification in prediabetes (Prameha).Materials and Methods: After the approval of Institutional Review Board, Independent Ethics Committee, and clinical trial registration in CTRI, 20 patients suffering with Prameha (~prediabetes) were registered in the clinical trial. Assessment criteria were: reduction in glycated hemoglobin (HBA1c), fasting plasma glucose (FBS), postprandial plasma glucose (PPBS), improvement in Agnibala (~strength of digestion and metabolism), Dehabala (~physical strength), and Satvabala (~mental strength), relief in signs and symptoms of prediabetes, and improvement in quality of life (SF-36 Score). Oral administration of Darvyadi Kwatha and lifestyle modification was given. Assessment was done on the 46th, 76th, 107th, and 120th day and Student paired t-test was used for analysis of data. Results: The outcomes showed a statistically highly significant reduction in assessment parameters (HBA1c [mean ± standard deviation [SD] before treatment [BT] 6.07 ± 0.26 and after treatment ORIGINAL ARTICLE 5.78 ± 0.22] [<0.001], FBS [mean ± SD BT 116.6 ± 12.5 and AT 102.0 ± 0.8.1] [<0.001], and PPBS [mean ± SD BT 168.7 ± 19.7 and AT 118.6 ± 12.0] [<0.001]). Conclusion: This clinical study concludes that Ayurveda medicine (Darvyadi Kwatha and lifestyle modification) is effective in the treatment and prevention of prediabetes turning into DM.

Keywords: Clinical trial, Darvyadi Kwatha, lifestyle modification, Prameha, prediabetes


How to cite this article:
Yadav U, Bhatted SK. Efficacy of palliative herbal decoction (Darvyadi Kwatha) with lifestyle modification in the management of prediabetes (Prameha): a single-arm clinical trial. J Indian Sys Medicine 2021;9:265-71

How to cite this URL:
Yadav U, Bhatted SK. Efficacy of palliative herbal decoction (Darvyadi Kwatha) with lifestyle modification in the management of prediabetes (Prameha): a single-arm clinical trial. J Indian Sys Medicine [serial online] 2021 [cited 2022 Oct 3];9:265-71. Available from: https://www.joinsysmed.com/text.asp?2021/9/4/265/334254




  Introduction Top


Prediabetes is a condition of hyperglycemia in the range of hemoglobin A1c 5.7%–6.4%, fasting blood sugar levels (BSL) between 100 and 125 mg/dL, and postprandial BSL between 140 and 200 mg/dL. Change in food habits, lifestyle, irregular sleep patterns, and mental stress or anxiety leads to an imbalance of the biological system of the body or in other words disturbs the threshold of the digestion, absorption, and distribution capacity in the intestine, further leading to an imbalance in the functional capacity of the endocrine system. Prediabetes is a metabolic disorder that can be compared with Prameha; based on the clinical signs and symptoms of prediabetes, it has a close resemblance to the disease Prameha described in Ayurveda.[1] A pathological condition characterized by excessive turbid urination is broadly termed as Prameha, which is further classified into 20 subtypes based on the involvement of Dosha and the presentation of urine; if not treated timely, all the Prameha in the due course of time will be converted into Madhumeha (~DM). Prameha is a disease that is caused due to Mandagni (~low digestive fire and metabolism),[2]Bahudosha (~excessive Dosha), Bahudrava Shleshma (Kapha with increased liquidity), and Abaddhameda (~increased bad cholesterol and triglyceride) along with an increase of Kleda (~excessive fluidity) in the body, all of which belong to the group of Kapha substances in the body.[3] Management of type 2 diabetes mellitus (T2DM) includes oral hypoglycemic drugs, which can further result in side effects caused due to medication; the condition deteriorates on the one hand and complications arise due to prediabetes on the other hand. So, we searched for the best remedy in Ayurveda medicine and Acharya Charaka has mentioned Darvyadi Kwatha for treating all types of diabetes. Prediabetes occurs due to a disturbed lifestyle, and Ayurveda medicine has enumerated a specific lifestyle for the patients with diabetes. Thus, we had made an alternative hypothesis, efficacy of oral administration of Darvyadi Kwatha and the life style modification in the management of Prameha w.s.r to prediabetes and null hypothesis do not have efficacy of oral administration of Darvyadi Kwatha and the life style modification in the management of Prameha w.s.r to prediabetes. Darvyadi Kwatha (Darvi, Suraha, Triphala, and Musta) mainly pacifying Kapha Dosha, especially indicated in diabetes.[4] Modified lifestyle mainly acts on biochemicals and it reaches normalcy level. Hence, oral administration of Darvyadi Kwatha with lifestyle modification was selected in this study.


  Materials and Methods Top


Inclusion criteria

Inclusion criteria were: age between 30 years and 60 years, obese patients, glycated hemoglobin (HBA1C) between 5.7% and 6.4%, fasting blood glucose between 100 and 125 mg/dL, and postprandial BSL between 14 and 200 mg/dL.

Exclusion criteria

Exclusion criteria were: Insulin dependent diabetes mellitus patients, gestational diabetes, patients on steroids or oral hypoglycemic drugs, malignant and accelerated hypertension, congestive cardiac failure, pregnant women, and lactating mother suffering with any serious disease condition.

Plan of study

After screening 36 patients, 20 patients were enrolled for oral administration of Darvyadi Kwatha at a dose of 80ml freshly prepared twice a day before food for one month; follow-up was done on the 46th, 76th, 106th, and 120th day. The primary end point was HBA1c; the secondary end points were fasting plasma glucose (FBS), postprandial plasma glucose (PPBS), signs and symptoms of Prameha, Agnibala, Dehabala, Satvabala, and quality of life by SF36 score.

Diagnostic criteria

The diagnostic criteria were: HBA1C between 5.7% and 6.4%, FBS between 100 mg/dL and 125 mg/dL, and postprandial blood glucose between 140 mg/dL and 200 mg/dL.

Trial drugs

The trial drug was Darvyadi Kwatha; the method of preparation involved boiling 20 g coarse powder of an equal quantity of Darvyadi Kwatha churna (Darvi, Suraha, Triphala, and Musta) with 320 mL of water, reducing it to 80 mL, and finally filtering it. The patients were advised to take the liquid part each time as freshly prepared Kwatha before food twice a day.[5]

Intervention

All patients were given Darvyadi Kwatha accompanied by lifestyle modification; all patients were advised to follow the following lifestyle modification:[6],[7],[8]

DO’S: Ahara (~diet): Lukewarm water, approximately 250–300 mL, before evacuation of stool. Breakfast—fiber-rich whole cereals such as barley, bajra, maize, ragi, and their products; the patient can also consume fruits such as papaya, pomegranate, and apple. Lunch—same as breakfast, pulses such as chickpea, pigeon pea, horse gram, green gram, leafy vegetables such as pointed gourd, bitter gourd, drumstick, and shallot (reddish carrot in moderate quantity as per appetite). Dinner—same as lunch but it should be light and taken between 7 p.m. and 8 p.m. Use sesame oil and linseed oil. Vihara (~code of conduct): Get up early in the morning, 60 min before sunrise (05:30 a.m. to 6:30 a.m.). Regular pranayama and yoga on an empty stomach for a minimum of 15 min daily (morning and evening).

Yoga:Naadishodhan pranayama, Utthitaparsvakonasana, Paschimottanasana, Janusirshasana, Makarasana, Dhanurasana, Halasana, Ardhamatsyendrasana, and Shashankasana all practice the asana to the best extent possible.[9]

Don’t: Avoid day sleep, milk and milk products, frozen food, bakery products, fast food, tea, coffee, and excessive drinking of water.

Assessment criteria

Objective criteria include: HBA1c, FBS, and PPBS; subjective criteria include signs and symptoms of Prameha, Agnibala, Dehabala, Satvabala [see [Table 1] and [Table 2]],[10] and quality of life by SF36 score details mentioned in [Table 2] and [Table 3]. Assessment was done for HBA1c on the 120th day; other parameters were evaluated on the 46th, 76th, 107th, and 120th day.
Table 1: Assessment criteria of signs and symptoms of Prameha

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Table 2: Assessment criteria of Agnibala, Dehabala, and Satvabala

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Table 3: Effects of intervention on objective parameters

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Ethics

Approval was obtained from the Institutional Ethics Committee (AIIA/2018/PG-73); the trial was registered in the clinical trial registry, India (CTRI/2019/03/017952), and it was registered prospectively. Informed consent forms were obtained from all enrolled individuals in the clinical trial.

Statistical analysis

The obtained data were analyzed for statistical significance by using Student’s paired t-test; a master chart of all the required data in a Microsoft Excel worksheet was prepared; and SPSS software was used for statistical analysis. The results were interpreted as significant (P < 0.05), highly significant (P < 0.01), and insignificant (P > 0.05).

Outcome

A total of 20 patients with prediabetes were registered; out of these, 18 patients completed the course of treatment with follow-up and two patients discontinued the treatment in between. Observation of study: It was found that the majority of the patients belonged to the age group of 40–49 years. Agni (~digestive fire) wise distribution shows that maximum patients were Vishmagni (~disturbed digestive fire) and Mandagni.[11] The majority of patients were Pitta-kapha and Vata-kaphaprakriti.[12]

Primary outcomes were improvement in HBA1c (<0.001) measurement; secondary outcomes were improvement in FBS (<0.001) and PPBS (<0.001), Agnibala (<0.001), Dehabala (<0.001), and Satvabala (<0.001) as per Ayurveda and overall improvement in quality of life (SF-36 Score)(<0.001).


  Results Top


All the objective parameters (HBA1c [mean ± standard deviation [SD] before treatment [BT] 6.07 ± 0.26 and after treatment ORIGINAL ARTICLE 5.78 ± 0.22] [<0.001], FBS [mean ± SD BT 116.6 ± 12.5 and AT 102.0 ± 0.8.1] [<0.001], and PPBS [mean ± SD BT 168.7 ± 19.7 and AT 118.6 ± 12.0] [<0.001]) were shown to produce statistically highly significant results. Signs and symptoms of Prameha, Dehabala, Agnibala, Satvabala, and quality of life (SF-36 Score) were also shown to produce statistically highly significant results [see [Table 3][Table 4][Table 5] and [Graph 1]–[Graph 2]]. Parameters (FBS and PPBS) were assessed during different intervals (Day 46, Day 76, Day 107, and Day 120); the results showed a gradual decrease in sugar level to normal level [see [Table 6] and [Graph 3]].{Table 3}
Table 4: Effect of intervention on subjective parameters

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Table 5: Effect of intervention on SF-36 Score

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Graph 1: Effect of intervention on HBA1c

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Graph 2: Effect of intervention on FBS and PPBS

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Table 6: Effect of intervention on PPBS in different intervals

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Graph 3: Effect of intervention on different intervals in FBS and PPBS

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  Discussion Top


Summary of key findings

The results of this clinical study proved an alternate hypothesis. There was an improvement in all the parameters; primary outcome measure HBA1c (<0.001) was highly significant; and secondary outcome measures FBS (<0.001), PPBS (<0.001), Prabhutmutrata (<0.001), Agnibala (<0.001), Dehabala (<0.001), Satvabala (<0.001) and quality of life (SF-36 Score) parameters showed statistically highly significant results.

Strengths and limitations

This clinical intervention not only treated prediabetes but also treated obesity and indirectly prevented one from life-threatening disorders such as cardiovascular disorder, stroke, hypertension, hypothyroidism, radiculopathy, etc.; it is also palatable, cost-effective, and feasible to the patients. However, this clinical intervention alone is not sufficient to treat high BSL and, thus, some other medication also needs to be used.

Study design

The following is the proposed graphical tree of the study design.



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Interpretation

Pathogenesis of prediabetes states with low digestive fire in general and Medodhatvagnimandya (~decrease metabolism of fatty acids) in particular due to which not able to convert glucose into glycogen, hence BSL increases. In prediabetes patients, Mandagni may occur on any three, two or one levels such as Jathragni (~digestive fire), Dhatvagni (~metabolic function), and Bhutagni (~neurotransmitters and receptors).[11]

Probable mode of action of Darvyadi Kwatha

The study of Darvyadi Kwatha shows its antidiabetic action; it acts on the gastrointestinal tract (GIT), which increases the Agni due to an ingredient such as Nagarmotha (Cyperus rotundus L.), the cleansing of GIT occurs due to ingredients such as Emblica officinalis (Amalaki), Terminalia bellerica (Bibhitaki), and Terminalia chebula (Haritaki), and reduces Kleda (~liquidity) in the body due to ingredients such as Triphala (~herbs), Devdaru (Cedrus deodara), Daruharidra (Berberis aristata), and Nagarmotha (C. rotundus L.)[13] This trial drug mainly acts on Agni, when increases the Agni specially Medodhatvagni subside the vitiated Doshas and break the Samprapti (pathogenesis) and also direct action on pancreas like stimulation and improving insulin secretion for improving BSL.

Probable mode of action of lifestyle modification

Lukewarm water liquefies the fat, enables weight loss, helps in digestion, and reduces excessive Kapha and related substances such as Kleda due to its heat property. Barley, bajra, maize, and ragi and its preparations liquefy fat and its related substances due to Ruksha (~rough) property. Timely consumption of food and good sleep habits have a positive effect on the biochemicals of the body and result in its attaining a normal level. Yoga exerts positive effects on the pancreas, such as stimulation, improving insulin secretion, improving BSL, and acting at the level of all health dimensions. Yoga practice is believed to have “beyond the drug action,” which refers to the potential to induce stem cell trafficking from the bone marrow to the peripheral blood, which may lead to tissue regeneration by replacement and recruitment of cells differentiated from the stem cells. Yoga asana also modulates gene expression and increases muscle activity, strength, endurance, flexibility, and balance, resulting in favorable effects on body weight, adiposity, dyslipidemia, and insulin resistance.[9] Exercise has a positive role in maintaining the glycemic level, increasing the insulin sensitivity, and also improving cardiovascular risk factors.[14]

Future research direction

This clinical study may be conducted on multicentric level and large sample sizes on the same research work and pharmacodynamics as well as pharmacokinetics action of Darvyadi Kwatha as well in the future.


  Conclusion Top


The results obtained on HBA1c (<0.001), FBS (<0.001), PPBS (<0.001), Prabhutmutrata (<0.001), Agnibala (<0.001), Dehabala (<0.001), Satvabala (<0.001), and quality of life (SF-36 Score) parameters were shown to be statistically highly significant. This study suggests that oral use of Darvyadi Kwatha at a dose of 80 ml twice a day before food with lifestyle modification can effectively treat prediabetes and prevent it from developing into DM.

Financial support and sponsorship

Nil

Conflicts of interest

None



 
  References Top

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Shivprasad S, editor. Pramehachikitasa. Chapter 4, Verse 2. In: Vagbhatta of Asthangsamgraha Chikitsasthana. Varanasi: Cukhambha Sanhaskrit Series Office; 2012. p. 513.  Back to cited text no. 1
    
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Rupesh W, Rambabu RD. Applicability and importance of Caraka’s concept of Aaturaparijnana Hetawah in understanding a patient. Ayu 2012;33:188-92.  Back to cited text no. 10
    
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Bhalerao S, Patwardhan K. Prakriti-based research: Good reporting practices. J Ayurveda Integr Med 2016;7:69-72.  Back to cited text no. 12
    
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    Figures

  [Figure 1], [Figure 2], [Figure 3], [Figure 4]
 
 
    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6]



 

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