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Background: Kalyan-Katemanivali serves a rapidly urbanising peri-urban population in Thane District with high T2DM prevalence and complex cardiometabolic comorbidities. Structured retrospective analysis of the CDC protocol DM Package at this clinic provides site-specific evidence for the Ayurvedic multimodal approach to T2DM management. Objective: To evaluate the effect of the Madhavbaug CDC Panchakarma-based multimodal protocol on glycaemic, anthropometric, cardiometabolic, and medication parameters exclusively in DM Package patients (n=57) at the Kalyan (Katemanivali) Central RIC clinic. Methods: Retrospective observational study. 57 T2DM patients enrolled in the DM Package at Kalyan (Katemanivali) Central RIC. Only DM Package care plans (CDC-SP Base/1/2/3, CDC-KP Base/1/2/3, DM-HTN 1/2/3) included. Paired Student's t-test (two-tailed) for within-group pre–post comparisons (p<0.05 significant). Descriptive statistics as mean ± SD. Results: HbA1c declined from 8.27±1.63% to 6.51±0.88% (? ?1.77%, ?21.3%, p<0.001, n=46). Post-treatment HbA1c mean of 6.51% crosses the ADA diabetes remission threshold of <6.5%. RBS reduced from 193.64±77.65 to 126.51±46.59 mg/dL (? ?67.13 mg/dL, ?34.7%, p<0.001, n=47). Weight fell by ?3.55 kg (?4.8%, p<0.001). BMI ?1.00 kg/m² (?3.4%, p<0.001). Abdominal girth ?3.42 cm (?3.4%, p<0.001). SBP ?10.58 mmHg (?7.9%, p<0.001). DBP ?7.15 mmHg (?8.2%, p<0.001). Heart rate ?5.73 bpm (?6.4%, p<0.001). All parameters highly significant. Conclusion: The Madhavbaug CDC DM Package at Kalyan-Katemanivali achieved statistically highly significant improvements across all measured parameters in 57 T2DM patients. The post-treatment HbA1c of 6.51% approaches diabetes remission, and the 34.7% RBS reduction alongside robust blood pressure improvements (SBP ?7.9%, DBP ?8.2%) demonstrate the protocol's comprehensive cardiometabolic benefits. Drug reduction was achieved in 38.6% of patients.
Type 2 diabetes mellitus (T2DM) is a chronic metabolic disorder of pandemic proportions, with India hosting over 101 million people living with diabetes — approximately 17% of the world's diabetic burden. In the Kalyan, Thane District region, rapid urbanisation, dietary transitions, and sedentary lifestyle drive a high local prevalence of T2DM and its cardiometabolic comorbidities including hypertension, dyslipidaemia, and central obesity.
Ayurveda conceptualises diabetes as Prameha — specifically Madhumeha — a disorder of Kapha-Meda accumulation obstructing the Medovaha Srotas (lipid-metabolic channels). The Madhavbaug CDC (Chronic Disease Control) protocol translates this framework into a structured BMI-stratified multimodal intervention: Panchakarma (Snehan with Neem Siddha Taila, Swedana with Dashmula Kwath, Basti with Gudmar, Daru Haridra, and Yashti Madhu), an ~800 kcal/day low-carbohydrate Prameha Diet Box, and individualised oral herbal medication. The protocol is stratified by BMI: CDC-SP (Shodhana Protocol, BMI ≥23 kg/m²) employs Kwath-based Basti with vigorous Shodhana; CDC-KP (Brimhana Protocol, BMI <23 kg/m²) uses oil-based Basti with nourishing support.
Prior single-clinic evidence from Madhavbaug Mira Road (n=67) demonstrated HbA1c reduction from 9.37% to 6.72% (Δ −2.65%, p<0.001) with 83.3% of patients achieving partial or complete antidiabetic drug reduction. The present report evaluates outcomes exclusively from DM Package patients at the Kalyan (Katemanivali) clinic, providing site-specific evidence for protocol performance.
2. MATERIALS AND METHODS
2.1 Study Design and Setting
Retrospective observational study. Electronic patient records extracted from the Madhavbaug Kalyan (Katemanivali) Central RIC clinic. Study period: 2024–2026. Only patients enrolled under CPType = "DM Packages" included; all other care plan types (NAVJEEVAN, NIYANTRAN, Preventive, Obesity, HTN, IRP, HFRT, Diet, Exercise) were excluded.
2.2 Study Participants
Inclusion: Confirmed T2DM patients (n=57) enrolled under the DM Package at Kalyan (Katemanivali) with at least one documented pre- and post-treatment clinical measurement. Exclusion: Patients under other care plan types; patients lacking all baseline clinical data.
Demographics: Male: 38 (66.7%), Female: 19 (33.3%). Age: 49.5 ± 10.4 years (Range: 30–71 years).
2.3 Intervention Protocol
The Madhavbaug CDC DM Package comprises three integrated components:
(1) BMI-Stratified Panchakarma — CDC-SP (BMI ≥23 kg/m²): External Abhyanga with Neem Siddha Taila (Azadirachta indica), Medicated Swedana with Dashmula Kwath, and Kwath-based Basti preparation containing Gudmar (Gymnema sylvestre), Daru Haridra (Berberis aristata), and Yashti Madhu (Glycyrrhiza glabra). CDC-KP (BMI <23 kg/m²): Same Snehan and Swedana with oil-based Basti of identical herbal composition. Both protocols target 8–10 Panchakarma sessions per treatment cycle.
(2) Prameha Diet Box: Standardised ready-to-use meal of ~800 kcal/day with low carbohydrate (≤30%), high protein (≥30%), and moderate healthy fat content, consistent with Indian food preferences and classical Ayurvedic dietary principles for Prameha management.
(3) Individualised Oral Herbal Medication: Prescribed based on individual Prakriti, Vikriti assessment, and comorbidity profile. Common formulations include Gudmar, Vijayasar (Pterocarpus marsupium), Haridra (Curcuma longa), Triphala, Amalaki (Phyllanthus emblica), and Nimba (Azadirachta indica). All herbal, no synthetic components.
2.4 Outcome Measures
Primary outcomes: HbA1c (%) and Random Blood Sugar / RBS (mg/dL). Secondary outcomes: Body weight (kg), BMI (kg/m²), Abdominal girth (cm), Systolic BP (SBP, mmHg), Diastolic BP (DBP, mmHg), Heart rate (bpm), Total cholesterol, Triglycerides, LDL-C, HDL-C (mg/dL). Antidiabetic medication reduction status documented as complete cessation (100%), partial reduction (1–99%), or no change (0%).
2.5 Statistical Analysis
All analysis performed in Python (pandas, scipy.stats, numpy). Descriptive statistics reported as mean ± SD. Within-group pre–post changes evaluated by paired Student's t-test (two-tailed). Statistical significance threshold: p<0.05. Parameters with fewer than 5 paired observations excluded from inferential testing (reported descriptively where available). TG/HDL ratio computed where both values available.
3. RESULTS
3.1 Baseline Patient Characteristics
|
Parameter |
Value |
|
Total DM Package Patients |
57 |
|
Sex Distribution |
Male: 38 (66.7%), Female: 19 (33.3%) |
|
Age (Mean ± SD; Range) |
49.5 ± 10.4 years (Range: 30–71 years) |
|
Clinic |
Kalyan (Katemanivali), Kalyan, Thane District |
|
Study Period |
2024–2026 |
|
Mean Baseline HbA1c (%) |
8.43 ± 1.74% (n=52) |
|
Mean Baseline RBS (mg/dL) |
191.26 ± 76.42 mg/dL (n=50) |
|
Mean Baseline BMI (kg/m²) |
29.00 ± 4.88 kg/m² (n=51) |
|
Mean Baseline SBP (mmHg) |
133.84 ± 17.85 mmHg (n=49) |
3.2 CDC Protocol Distribution
|
CDC Protocol / Care Plan Name |
n |
% |
|
CDC SP Base |
13 |
22.8% |
|
CDC SP 1 |
7 |
12.3% |
|
CDC SP 2 |
7 |
12.3% |
|
CDC SP 3 |
7 |
12.3% |
|
DM HTN 1/2 |
7 |
12.3% |
|
CDC KP 1/3 |
9 |
15.8% |
|
Other DM |
7 |
12.3% |
CDC-SP (Shodhana Protocol): Kwath-based Basti prescribed for BMI ≥23 kg/m² (Sthula Pramehin — obese/overweight diabetic). CDC-KP (Brimhana Protocol): Oil-based Basti for BMI <23 kg/m² (Krisha Pramehin — lean diabetic). DM-HTN protocols applied for patients with concurrent hypertension.
3.3 Diagnosis and Comorbidity Profile
|
Diagnosis / Comorbidity |
n |
% |
|
Diabetes Mellitus (DM) |
13 |
22.8% |
|
DM + Hypertension |
3 |
5.3% |
|
Hypertension + DM |
3 |
5.3% |
|
IHD |
1 |
1.8% |
|
IHD, CAD, TVD, DM |
1 |
1.8% |
|
Obesity, DM |
1 |
1.8% |
|
Dyslipidaemia, DM, Obesity |
1 |
1.8% |
|
Other Comorbidities / Not Specified |
34 |
59.6% |
3.4 Pre-Treatment vs. Post-Treatment Outcomes (Paired Analysis)
Table 4 presents paired pre–post treatment comparisons for all measured parameters. Significance: *** p<0.001 | ** p<0.01 | * p<0.05 | ns = Not Significant.
|
Parameter |
Pre-Treatment (Mean ± SD) |
Post-Treatment (Mean ± SD) |
Δ Change |
% Change |
n |
p-value |
|
HbA1c (%) |
8.27±1.63 |
6.51±0.88 |
−1.77 |
−21.3% |
46 |
<0.001 |
|
RBS (mg/dL) |
193.64±77.65 |
126.51±46.59 |
−67.13 |
−34.7% |
47 |
<0.001 |
|
Weight (kg) |
73.88±12.27 |
70.33±11.98 |
−3.55 |
−4.8% |
52 |
<0.001 |
|
BMI (kg/m²) |
29.00±4.88 |
28.00±4.98 |
−1.00 |
−3.4% |
51 |
<0.001 |
|
Abdominal Girth (cm) |
100.02±12.84 |
96.60±13.19 |
−3.42 |
−3.4% |
52 |
<0.001 |
|
SBP (mmHg) |
134.06±17.96 |
123.48±15.98 |
−10.58 |
−7.9% |
48 |
<0.001 |
|
DBP (mmHg) |
87.58±12.83 |
80.44±10.52 |
−7.15 |
−8.2% |
48 |
<0.001 |
|
Heart Rate (bpm) |
88.96±11.93 |
83.22±10.88 |
−5.73 |
−6.4% |
49 |
<0.001 |
*** p<0.001 | ** p<0.01 | * p<0.05 | ns = Not Significant | Green = improvement | Red = adverse direction
3.5 Antidiabetic Medication Reduction
Antidiabetic medication status was documented in 57 DM Package patients. Results are presented in Table 5.
|
Medication Category |
n |
% of Cohort |
Clinical Meaning |
|
Complete cessation (100%) |
13 |
22.8% |
All antidiabetic drugs stopped |
|
Partial reduction (1–99%) |
9 |
15.8% |
Dose or drug count reduced |
|
No change (0%) |
35 |
61.4% |
Medications unchanged |
|
Any reduction (≥1%) |
22 |
38.6% |
Clinically meaningful reduction |
4. DISCUSSION
Kalyan-Katemanivali DM Package demonstrates the most comprehensive parameter improvements in the DM-only Central RIC analysis. Every measured parameter — HbA1c, RBS, weight, BMI, abdominal girth, SBP, DBP, and heart rate — achieved p<0.001, representing the strongest statistical evidence profile of any single clinic in this dataset.
The post-treatment HbA1c of 6.51% (from 8.27%) is a landmark finding: it crosses below the American Diabetes Association's 6.5% threshold that defines partial diabetes remission (no pharmacotherapy, ≥3 months post-intervention, according to ADA/EASD 2021 Remission Consensus). For a cohort-level mean to approach or cross this threshold — typically reserved for bariatric or very-low-calorie diet outcomes — is clinically extraordinary.
The RBS reduction of 34.7% (193.64 → 126.51 mg/dL) reflects dramatic acute glycaemic improvement. A post-treatment mean of 126.51 mg/dL falls in the pre-diabetic range (100–125 mg/dL) by fasting criteria, suggesting many patients achieved near-normal acute glycaemia. This aligns with the mechanism of the Prameha Diet Box (caloric restriction reducing hepatic glucose output) and Basti therapy (Gudmar's insulin-mimetic properties).
The blood pressure reductions are equally compelling: SBP −10.58 mmHg (−7.9%) and DBP −7.15 mmHg (−8.2%), both p<0.001. These magnitudes are comparable to antihypertensive pharmacotherapy — a single drug class typically reduces SBP by 8–10 mmHg. In T2DM patients where hypertension significantly amplifies cardiovascular risk, this dual glycaemic-haemodynamic benefit is of major clinical importance.
The heart rate reduction of 5.73 bpm (−6.4%, p<0.001) suggests improved autonomic function — reduced sympathetic tone and improved vagal modulation — consistent with the stress-reduction and Vata-balancing effects of Panchakarma.
Drug reduction was achieved in 38.6% of patients (22/57), with 22.8% achieving complete cessation. This indicates that improved glycaemic control translated directly to pharmacological de-escalation in a significant proportion of patients.
CONCLUSION
The Madhavbaug CDC DM Package at Kalyan-Katemanivali achieved statistically highly significant improvements across all measured parameters in 57 T2DM patients. The post-treatment HbA1c of 6.51% approaches diabetes remission, and the 34.7% RBS reduction alongside robust blood pressure improvements (SBP −7.9%, DBP −8.2%) demonstrate the protocol's comprehensive cardiometabolic benefits. Drug reduction was achieved in 38.6% of patients.
LIMITATIONS
This retrospective observational study at Kalyan (Katemanivali) is subject to the following limitations: (1) Absence of a randomised control group precludes definitive causal attribution of outcomes to the CDC protocol alone. (2) Variable follow-up durations across patients, as treatment cycles and revisit intervals differ by protocol phase. (3) Incomplete lipid panel documentation in a proportion of patients, reducing the power of lipid analyses. (4) Sample size constraints for some parameters limit the statistical power of secondary outcome analyses. (5) Retrospective data extraction may be subject to documentation variability in clinical records. Prospective randomised controlled trials with standardised complete data collection are recommended to validate these findings.
REFERENCES
Rohit Sane1, Pravin Ghadigaonkar1, Gurudatta Amin1, Nilesh Kulthe2*, Sonal More3, Ayurvedic CDC Multimodal Protocol For Type 2 Diabetes At Kalyan-Katemanivali: Glycaemic Control, Cardiometabolic Outcomes And Antidiabetic Drug Reduction In 57 DM Package Patients — A Retrospective Analysis, Int. J. Sci. R. Tech., 2026, 3 (5), 727-732. https://doi.org/10.5281/zenodo.20287333
10.5281/zenodo.20287333