alexa Efficacy of Ayurveda Formulation Ayush-82 (IME-9) in Newly Diagnosed Type 2 Diabetics: Retrospective Analysis of Individual Data | OMICS International
ISSN: 2573-4555
Journal of Traditional Medicine & Clinical Naturopathy
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Efficacy of Ayurveda Formulation Ayush-82 (IME-9) in Newly Diagnosed Type 2 Diabetics: Retrospective Analysis of Individual Data

Ashok Kumar Panda1*, KK Ratha1 and MM Rao2

1Research Officer (Ayurveda), Centralleal Ayurveda Research Institute of Hepatobiliary Disorders, Bharatpur, Bhubaneswar -751029, CCRAS, M/O AYUSH, Govt Of India.

2Central Ayurveda Research Institute of Hepatobiliary Disorders, Bharatpur, Bhubaneswar-751029, Odisha, India

*Corresponding Author:
Ashok Kumar Panda
Research Officer (Ayurveda)
Centralleal Ayurveda Research Institute of Hepatobiliary Disorders
Bharatpur, Bhubaneswar -751029, CCRAS
M/O AYUSH, Govt Of India
Tel: 03592-231494
E-mail: [email protected]

Received date: October 04, 2017; Accepted date: November 08, 2017; Published date: November 08, 2017

Citation: Panda AK, KK Ratha, MM Rao (2017) Efficacy of Ayurveda Formulation Ayush-82 (IME-9) in Newly Diagnosed Type 2 Diabetics: Retrospective Analysis of Individual Data. J Tradit Med Clin Natur 6:250.

Copyright: © 2017 Panda AK, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

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Abstract

Ayush 82 is formulated and clinically proven by Central Council Research in Ayurveda Sciences, M/o of AYUSH, GOI for diabetic care. Recently Right Sugar (Chaturbhuj Pharmaceutical), IME-9 (Kudos Ayurveda) and BGR-34 (AIMIL Pharmaceutical) have drawn the attention of many diabetic consumers as these products are developed from scientific organizations of government and highlighted in electronic and print media. IME-9 (Kudos Ayurveda) developed from Ayush 82 of Central Council Research in Ayurveda Sciences, M/o of AYUSH, GOI. Most of the patients consuming IME-9 attend Ayurvedic hospitals and clinics for evaluation of their blood sugar level to know the efficacy of the drug and for consultation. Therefore, an initiative was taken to analyze the safety and efficacy of IME-9 in newly diagnosed diabetic patients taking an IME-9 tablet or have a primary prescription of the same. IME-9 was able to reduce (96%) the blood glucose of all newly diagnosed cases, whereas glycosylated haemoglobin level was reduced in all newly diagnosed cases except in one. Total 12 (48%) patients have shown the improvement of blood glucose and glycosylated haemoglobin (up to 7). It is also observed that in three cases blood glucose level was increased after 2 weeks of treatment and significant reduction of blood glucose was found after the 8th week. So IME-9 may be the first line choice of herbal treatment of newly diagnosed cases along with a change in lifestyle.

Keywords

Ayush 82; IME-9; BGR-34; Glycosylated haemoglobin; Blood sugar

Introduction

Diabetes is fast growing disease and got the status of a potential epidemic in India with more than 62 million diabetic individuals currently diagnosed with the disease [1]. Many patients are tempted to look for Ayurveda remedies as their life-long therapy for diabetic and its complications. More than 50% diabetic patients taking OHA (Oral hypoglycemic agents) and herbs concomitantly but only about 05% patients consult Ayurveda doctor before starting any herbal medicine for diabetes. Studies highlight the high prevalence of self-medication of herbal/Ayurveda medicine by patients with T2DM concomitantly with prescribed medication [2,3]. Diabetic patients purchase Ayurveda medicines through online shopping, marketing network, on phone call, and through teleshopping [4]. Direct to consumer advertisement (DTC) through electronic and print media on Ayurveda proprietary medicines are thought to be a good way to attract chronic diseases suffers and a good source of high return in short time by pharmaceutical companies [5]. The pharmaceutical companies involved in DTC, hesitate to pursue their products through doctor’s prescription because they have no/insufficient evidence, rather they sold as OTC (Over the counter) sale products [6]. Ayurveda and other forms of alternative medicine for diabetes are increasingly visible in the public domain; with some officials describing them as effective and emphasizing a supposed absence of side-effects are maximum hype with minimum science [7].

It can affect glucose metabolism, but evidence for their clinical use in patients with diabetes is scarce [8,9]. Every 4th member from diabetic patients in India used herbs/Ayurveda and yoga for their ailments in their life time.

Sometimes they co-administrated with conventional antidiabetic drugs with herbal products, in where possibilities of drug-herb interactions, that may antagonist or synergistic to the drug [10-12]. Efficacy of Ayurveda remedies and Panchakarma procedures of thirty clinical trials were reviewed and found a significant improvement in mild to moderate hyperglycaemia12. Recently Right Sugar (Chaturbhuj Pharmaceutical), IME-9 (Kudos Ayurveda) and BGR-34 (AIMIL Pharmaceutical) have drawn the attention of many diabetic consumers as these products are developed from the government scientific organization and highlighted in media [13,14]. Right sugar (Chaturbhuj Pharmaceutical) and IME-9 (Kudos Ayurveda) developed from Ayush 82 of Central Council Research In Ayurveda Sciences, M/o of AYUSH, GOI [15-17] whereas BGR-34 launched commercially by the Council of Scientific and Industrial Research (CSIR) laboratory and published clinical data are not available on various search engines and PubMed [18]. Right Sugar (Chaturbhuj Pharmaceutical) has chosen the platform of advertisement in leading newspaper of many states and the union territory of India; whereas IME-9 has commenced marketing through television. Many patients have come to our hospital and questioning the credibility of Right sugar and IME-9 preparations. Most of the patients consumed IME-9 and have come for an evaluation of blood sugar. Retrospective studies were conducted in Chinese traditional medicine to generate clinical evidence of prescribing medication on diabetic but is rarely seen in Ayurveda [19-22]. Therefore an initiative was taken to analyze the safety and efficacy of IME-9 in newly diagnosed diabetic patients taking the medicine i.e IME-9.

Methods

The clinical records of CARIHD, Bhubaneswar were used as the database. The newly diagnosed cases of T2DM consuming either as a prescription drug or as self-medication drugs are included only in the study. The patients who met the inclusion criteria were from 1st Sep 2016 to 31st March 2017 were enrolled in the study. The diagnostic criteria referred to WHO T2 DM diagnostic criteria (1999)22 and Ayurveda guidelines for prevention and management of diabetes [23]. The other inclusion criteria include patients of either gender or age in between 18 yrs to 70 yrs with a confirmed diagnosis of T2DM and not more than two years. The patient should under diet control and exercise or herbal medication. Patients using monotherapy or multiple OHA or under insulin therapy are excluded from the study. The individual data of the recruited subjects were analysed in terms of the individual attributes and changes noticed in the blood sugar and glycosylated haemoglobin level.

The individual data analysis is a preferable method when data are scanty and no relation established among them [24]. Sometimes individual attributes are ignored in the statistical mean analysis. There is a limitation of retrospective analysis in drug efficacy as there are no control groups still retrospective analytical studies are observed in diabetic research [25].

Results and Discussion

Total 210 diabetic patients attended the OPD during the study period. Only 67(32%) patients were consuming IME-9. 32 (47%) Patients received the IME-9 as a primary prescription drug, whereas rest of patients 35 (53%) had been used the medicine from telemarketing and came for a free supply. 34 patients met the inclusion criteria as decided before and nine patients discontinued the analysis without stating the cause of dropout. Total twenty-five patients had completed the 12 weeks of management (Figure 1).

homeopathy-ayurvedic-retrospective-analysis

Figure 1: Schematic diagram of the current retrospective analysis.

Among 25 patients, 18 (72%) patients were male and 10 (40%) patients have the family history of diabetes. It observed that 04 (16%) patients were below 40 yrs of age and 9 (36%) patients were below 50 yrs of age. It revealed that 8 (32%) patients have a maximum duration of impaired blood sugar (2 yrs) and only 01 patient diagnosed accidentally in our hospital. 16(64%) patients have BMI more than 25 [26-29] (Table 1).

Sl. No. Age in years Sex BMI Parental history Duration of disease
1. 33 M 26.2 Absent One week
2. 46 F 25.6 Absent 11 months
3. 48 F 24.8 Present Two days
4. 52 F 32.8 Present 2 month
5. 50 M 22.4 Present 2 years
6. 34 M 25.6 Present 45 days
7. 47 F 23.6 Absent Two months
8. 77 M 22.1 Absent 30days
9. 56 M 26.2 Absent 120 days
10. 41 M 25.2 Present 6 months
11. 62 M 23.2 Absent 60 days
12. 47 M 25.8 Present One year
13. 60 M 22.2 Absent 2years
14. 48 M 25.6 Present  2 years
15. 38 F 32.4 Absent 02 years
16. 41 M 23.4 Present 02 years
17. 45 M 27.8 Absent 18 months
18. 53 M 22.8 Absent Two years
19. 56 M 32.6 Present One year five months
20. 61 M 32.4 Present 60 days
21. 59 F 31.6 Present One week
22. 74 M 20.4 absent 02 months
23. 57 M 28.4 Absent Two years
24. 38 M 26.2 Absent Six months
25. 44 M 25.6 Absent 2 years

Table 1: Individual data of age, sex, BMI, parental history and duration of disease in observed cases.

IME-9 was able to reduce the blood glucose of all newly diagnosed cases but glycosylated haemoglobin reduced in all newly diagnosed (96%) cases except in case no-5. Total 12(48%) patients have shown the improvement in blood glucose and glycosylated haemoglobin (up to 7) level. It also observed that in three cases blood glucose level increased after 2 weeks of treatment and significant reduction of blood glucose was found after 8th weeks (Table 2). No adverse effect was found in observed patients during the study.

Pt No. D0 2nd Week 4th Week 8th Week 12th Week
FBS PPBS HbA1C FBS PPBS FBS PPBS FBS PPBS FBS PPBS HbA1C
1 160 238 8.8 160 213 133 166 87 107 90 117 6.8
2 129 257 9.0 130 250 132 218 122 198 118 173 7.2
3 220 442 13.8 160 313 164 298 152 216 114 168 6.8
4 295 350 13.2 280 360 250 300 210 280 212 284 9.6
5 386 482 8.5 390 510 380 490 300 412 286 392 13.6
6 325 450 8.9 300 400 200 385 114 325 112 225 7.6
7 280 420 13.2 190 310 200 300 102 260 100 184 7.2
8 I96 290 9.6 155 210 160 192 140 184 112 136 6.4
9 155 270 8.6 112 255 118 198 102 170 96 166 7.2
10 357 550 13.3 220 347 180 317 150 270 98 142 7.0
11 109 257 7.8 110 218 116 215 98 198 97 167 7.0
12 160 222 7.8 168 220 117 202 94 193 79 110 6.8
13 253 392 13.2 258 412 224 358 176 260 168 218 8.6
14 194 276 8.6 212 258 92 135 98 146 96 160 7.2
15 384 524 14.6 250 412 217 360 212 342 198 378 10.6
16 295 350 9.6 216 250 130 188 133 198 132 198 7.2
17 212 356 10.2 240 370 186 324 156 256 144 232 7.8
18 194 284 8.2 190 280 184 273 124 205 98 178 7.0
19 178 312 7.8 200 242 168 212 164 256 142 264 8.2
20 210 398 13.8 298 407 256 410 213 368 189 366 13.4
21 160 218 7.4 87 150 142 202 154 198 86 146 6.8
22 220 442 10.2 160 385 168 346 164 298 90 117 6.4
23 180 223 7.8 112 180 98 164 134 168 140 180 7.0
24 160 202 7.2 NA NA 112 178 96 154 112 146 6.8
25 198 388 12.6 NA NA 89 176 94 180 91 162 6.6

Table 2: Individual patient’s observation of blood sugar and glycosylated haemoglobin before and after treatment.

Conclusion

So, Ayush 82 may be the first line of herbal treatment option for newly diagnosed cases along with a change in lifestyle. A large population-based study is recommended.

References

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