Clinical Outcomes Of The CDC Panchakarma Protocol With Prameha Diet Box In Type 2 Diabetes Mellitus With Metabolic And Cardiovascular Comorbidities: A Real-World Observational Study

Type 2 Diabetes Mellitus (T2DM) is a rapidly escalating global health burden, with an estimated 537 million adults affected worldwide and projections exceeding 783 million by 2045 [1]. India carries the second-highest diabetic burden globally, with approximately 77 million diagnosed cases [2]. T2DM rarely presents in isolation; the majority of patients harbour one or more metabolic and cardiovascular comorbidities — including hypertension, dyslipidemia, coronary artery disease, chronic kidney disease, and obesity — which compound disease severity, increase pharmacological complexity, and significantly elevate the risk of adverse outcomes [3,4].

The management of T2DM with multiple comorbidities is among the most challenging problems in contemporary clinical medicine. Current pharmacological approaches require multi-drug regimens, often including antidiabetics, antihypertensives, statins, and antiplatelet agents, with cumulative adverse effect burdens and significant risks of drug interactions. Despite pharmacotherapeutic advances, long-term glycemic and cardiovascular risk control remains suboptimal in a substantial proportion of patients [5]. These limitations have intensified interest in integrative medical approaches that address the underlying metabolic dysfunction through multi-modal, non-pharmacological interventions.

Ayurveda, the classical Indian system of medicine, describes T2DM under the concept of Prameha — a metabolic-urinary disorder arising from Kapha dosha vitiation, Ama (metabolic waste) accumulation, and impaired tissue metabolism [6]. The CDC (Comprehensive Diabetes Care) Protocol represents a structured, protocol-driven Ayurvedic intervention combining three simultaneous therapeutic modalities: Panchakarma bio-purification therapies, the Prameha Diet Box (a ready-to-use 800 kcal/day low-carbohydrate meal), and individualized oral herbal medications. The Panchakarma component comprises Snehan (external oleation with Neem Siddha oil), Swedhan (sudation with Dashmukada), and Basti (medicated per-rectal enema with Gudmar, Daru Haridra, and Yashti Madhu), administered as either a Kashaya (decoction-based, CDC-SP) or Taila (oil-based, CDC-KP) preparation based on patient BMI [7].

The three principal herbs used in Basti have documented antidiabetic mechanisms: Gudmar (Gymnema sylvestre) stimulates insulin secretion and reduces intestinal glucose absorption [8]; berberine from Daru Haridra (Berberis aristata) activates AMPK, enhancing glucose uptake analogously to metformin [9]; and Yashti Madhu (Glycyrrhiza glabra) inhibits alpha-glucosidase and modulates inflammatory pathways implicated in diabetic cardiovascular disease [10]. The Prameha Diet Box integrates classical Ayurvedic dietary prescription for Prameha with evidence-based very low-calorie diet (VLCD) principles; the DiRECT trial demonstrated T2DM remission in 46% of patients at one year using a structured 800-kcal VLCD [11].

Despite this theoretical basis, real-world observational data on the CDC Protocol — particularly in patients with significant comorbid cardiovascular and metabolic disease — are sparse. The Dombivali East patient cohort, characterized by a high burden of comorbid hypertension (19.4%), dyslipidemia (21.0%), coronary artery disease (11.3%), and chronic kidney disease (4.8%), provides a particularly clinically important real-world context for evaluating this protocol. The present study aimed to assess glycemic, anthropometric, and blood pressure outcomes of the CDC Protocol in this high-comorbidity cohort.

2. MATERIALS AND METHODS

2.1 Study Design and Setting

This was a retrospective observational study of T2DM patients treated at the Dombivali East branch of a multisite Ayurvedic diabetes care clinic (Thane district, Maharashtra, India) between April 2025 and March 2026. All data were derived from routinely collected clinical records; no experimental intervention was conducted for research purposes.

2.2 Participants

Inclusion criteria: (i) confirmed T2DM diagnosis (Type 1 DM excluded); (ii) enrollment in a CDC DM Package care plan; (iii) receipt of at least one Panchakarma session under the CDC Protocol; and (iv) complete baseline and follow-up data for primary outcome variables. Exclusion criteria: Type 1 or secondary diabetes; pregnancy or lactation; incomplete baseline records; or comorbidities unrelated to the metabolic syndrome. A total of 62 patients meeting all criteria were included.

2.3 Intervention Protocol

All patients received three concurrent therapeutic components: (1) BMI-stratified Panchakarma (CDC-SP for BMI ≥23 kg/m²; CDC-KP for BMI <23 kg/m²); (2) the Prameha Diet Box (800 kcal/day, low-carbohydrate/high-protein/high-fat composition); and (3) individualized oral Ayurvedic herbal medications prescribed based on each patient's constitution, comorbidities, and disease severity. Protocol specifics are described in Table 1. A total of 509 Panchakarma sessions were administered across the cohort (mean 8.2±3.7 per patient; range 0–18).

Kashaya = aqueous herbal decoction; Taila = oil-based herbal preparation; SP = Sthula Pramehi (obese/overweight); KP = Krisha Pramehi (normal/lean body weight).

2.4 Outcome Measures

Clinical parameters were recorded at care plan initiation (baseline) and at the most recent clinic visit (post-treatment). Primary outcomes: HbA1c (%), random blood sugar (RBS, mg/dL), body weight (kg), BMI (kg/m²). Secondary outcomes: abdominal girth (cm), systolic and diastolic blood pressure (mmHg), heart rate (bpm), and lipid profile (total cholesterol, triglycerides, HDL, LDL — analyzed among patients with complete non-zero paired data only). Allopathic medication status was documented at Day 1 and at last visit, with reduction categorized as 0%, 50%, 60%, 80%, 90%, or 100% (complete discontinuation).

2.5 Statistical Analysis

Continuous variables are expressed as mean ± standard deviation (SD). Paired two-tailed Student's t-tests were used to compare baseline and post-treatment values for all continuous parameters. A p-value <0.05 was considered statistically significant. Lipid parameters were analysed only among patients with complete non-zero paired data; subgroup comparison between CDC-SP and CDC-KP was descriptive. All 62 patients had complete primary outcome data; no imputation was performed.

2.6 Ethical Considerations

This study was conducted as a retrospective analysis of routinely collected clinical records in accordance with the ethical principles of the Declaration of Helsinki. All patient data were anonymized prior to analysis. [Insert ethics committee approval reference or waiver details prior to submission.]

3. RESULTS

3.1 Baseline Characteristics

Sixty-two patients with T2DM were included: 29 male (46.8%) and 33 female (53.2%), with a mean age of 49.3±12.6 years (range 26–72). This cohort was notably older and had a higher comorbidity burden than typical diabetes studies; 19.4% had comorbid hypertension, 21.0% dyslipidemia, 11.3% coronary artery disease or ischaemic heart disease, and 4.8% chronic kidney disease. Principal diagnoses included T2DM alone (n=28, 45.2%), T2DM with obesity (n=8, 12.9%), and T2DM with IHD/dyslipidemia/CHF (n=3, 4.8%). Fifty-four patients (87.1%) were allocated to CDC-SP (mean baseline BMI 27.3±3.5 kg/m²) and eight (12.9%) to CDC-KP (mean baseline BMI 22.1±2.1 kg/m²). Baseline characteristics are presented in Table 2.

Table 2. Baseline Demographic and Clinical Characteristics (n = 62)

Values expressed as mean ± SD unless stated. IHD = ischaemic heart disease; CAD = coronary artery disease; CKD = chronic kidney disease; SBP/DBP = systolic/diastolic blood pressure.

3.2 Primary Outcomes: Glycemic Parameters

The CDC Protocol produced highly significant improvements in both primary glycemic parameters. HbA1c declined from 8.63±2.02% at baseline to 7.28±1.76% post-treatment — an absolute reduction of 1.36±1.53 percentage points (−15.7%; p<0.001). This represents the largest absolute HbA1c reduction observed, with a t-statistic of 7.001, reflecting a very high effect size. At baseline, 19 patients (30.6%) had HbA1c exceeding 9.0%; post-treatment, this was reduced to 8 patients (12.9%). Post-treatment, 46.8% of patients (n=29) achieved HbA1c <7.0% — a clinically meaningful glycemic target — and 74.2% (n=46) achieved HbA1c <8.0%.

Random blood sugar declined from 202.1±90.7 mg/dL to 165.9±62.6 mg/dL (Δ −36.1±88.1 mg/dL; −17.9%; p=0.002). At baseline, 25 patients (40.3%) had RBS ≥200 mg/dL; post-treatment, 75.8% of patients (n=47) had RBS below 200 mg/dL.

3.3 Secondary Outcomes: Anthropometric Parameters

Statistically significant reductions were observed in body weight and BMI. Body weight declined from 67.59±10.96 kg to 66.02±10.85 kg (Δ −1.57±3.21 kg; −2.3%; p<0.001); 15 patients (24.2%) achieved ≥5% body weight reduction and 24 patients (38.7%) achieved ≥3% reduction. BMI declined from 26.63±3.78 to 25.92±3.59 kg/m² (Δ −0.71±1.24 kg/m²; −2.7%; p<0.001). Abdominal girth showed a mean reduction of 2.39 cm (84.61 to 82.23 cm) but this did not reach statistical significance (p=0.539), likely due to a high standard deviation driven by outliers in the cohort.

3.4 Secondary Outcomes: Cardiovascular Parameters

Systolic blood pressure showed a marginally significant reduction from 128.40±23.35 mmHg to 122.98±11.06 mmHg (Δ −5.42±21.27 mmHg; −4.2%; p=0.049). This finding is clinically noteworthy given that 19.4% of this cohort had comorbid hypertension and the study was not specifically powered to detect blood pressure changes. No significant changes were observed in diastolic blood pressure (Δ −2.87 mmHg; p=0.119) or heart rate (Δ −0.10 bpm; p=0.959). Full results are presented in Table 3.

Table 3. Clinical Outcomes — Baseline vs. Post-Treatment Comparison (n = 62)

Values expressed as mean ± SD. Paired two-tailed Student's t-test. * p<0.05; ** p<0.01; *** p<0.001; ns = not significant. Lipid parameters analyzed among patients with complete non-zero paired data only (n=13 for TC/TG/HDL; n=29 for LDL); all other parameters n=62.

3.5 Lipid Profile

Lipid data were available for 13 patients (21.0%) for total cholesterol, triglycerides, and HDL, and for 29 patients (46.8%) for LDL. No statistically significant changes were observed in any lipid parameter. The limited data availability precludes meaningful interpretation of lipid outcomes; this represents a significant gap in the dataset and prospective lipid monitoring is recommended in future studies.

3.6 Subgroup Analysis: CDC-SP vs CDC-KP

Descriptive analysis showed numerically comparable HbA1c reductions in CDC-SP (Δ −1.33%, n=54) and CDC-KP (Δ −1.54%, n=8) groups. In contrast to the Sthula Pramehi (overweight/obese) pattern in CDC-SP patients, the CDC-KP cohort showed a larger absolute HbA1c reduction but a substantially smaller RBS reduction (Δ −8.6 mg/dL vs Δ −40.2 mg/dL in CDC-SP), suggesting differing pathophysiological subtypes responding to the BMI-stratified Taila versus Kashaya Basti preparations. Due to the small KP subgroup (n=8), formal statistical comparison was not performed.

3.7 Allopathic Medication Status

Allopathic medication reduction was observed in 9 of 62 patients (14.5%). Of these, 2 patients (3.2%) achieved complete discontinuation of all allopathic medications, while 7 achieved partial reductions ranging from 50% to 90%. The majority of patients (n=47, 75.8%) showed no change in medication requirement. This rate is substantially lower than might be expected from glycemic improvement data alone and reflects the appropriately conservative clinical approach to medication management in a cohort with significant cardiovascular comorbidities including CAD, CHF, CKD, and arrhythmia, where pharmacological therapy is medically essential regardless of glycemic status. The medication distribution is presented in Table 4.

Table 4. Allopathic Medication Reduction — Distribution by Category (n = 62)

Reduction % assigned by treating physician based on overall pharmacological load at Day 1 versus last clinic visit. The low reduction rate reflects the high cardiovascular and renal comorbidity burden in this cohort, where medication maintenance is clinically indicated independent of glycemic control.