(Procedure Reference: Sharma, R. K., & Dash, B. (2014). Charaka Samhita (Vols. 1–6). Varanasi, India: Chowkhamba Sanskrit Series Office, Procedure details: Virecana Karma will be done With Eranda sneha & dinadayal churna according to koshtha, bala and agni after performing Abhyanga and Svedana ) (1) Medicine Name: Eranda sneha , Reference: Sharma, R. K., & Dash, B. (2014). Charaka Samhita (Vols. 1–6). Varanasi, India: Chowkhamba Sanskrit Series Office, Route: Oral, Dosage Form: Taila, Dose: 50(ml), Frequency: od, Duration: 1 Days(2) Medicine Name: Dinadayal churna , Reference: Vāgbhaṭa. (2012). Aṣṭāṅga Saṅgraha (Cikitsāsthāna 23/48) (K. R. Srikantha Murthy, Ed. & Trans.). Varanasi: Chaukhambha Orientalia, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: od, Duration: 1 Days
2
Intervention Arm
Procedure
-
sadyasnehaH, सद्यस्नेहः
(Procedure Reference: Sharma, R. K., & Dash, B. (2014). Caraka Samhita (Vol. 1–6). Varanasi, India: Chowkhamba Sanskrit Series Office., Procedure details: Snehapana with Panchatikta ghrita will be start with 40 ml increasing dosage till samyaka snigdha lakshana achieve ) (1) Medicine Name: Panchatikta ghrita , Reference: Sharma, R. K., & Dash, B. (2014). Charaka Samhita (Vols. 1–6). Varanasi, India: Chowkhamba Sanskrit Series Office, Route: Oral, Dosage Form: Ghrita, Dose: 40(ml), Frequency: bd, Duration: 7 Days
3
Intervention Arm
Procedure
-
svedanam, स्वेदनम्
(Procedure Reference: Sharma, R. K., & Dash, B. (2014). Charaka Samhita (Vols. 1–6). Varanasi, India: Chowkhamba Sanskrit Series Office., Procedure details: Svedana will be done with Nirgundi patra) (1) Medicine Name: Nirgundi , Reference: Chunekar, K. C., & Pandey, G. S. (2010). Bhavaprakasha Nighantu. Varanasi, India: Chaukhambha Bharati Academy., Route: Topical, Dosage Form: Not Applicable, Dose: 0(NA), Frequency: od, Duration: 26 Days
4
Intervention Arm
Drug
Classical
(1) Medicine Name: Meshashringi churna , Reference: Government of India, Ministry of Health and Family Welfare. (2006). The Ayurvedic Pharmacopoeia of India (Part 1, Vol. 5, Monograph No. 51). New Delhi: Department of AYUSH, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 79 Days, anupAna/sahapAna: Yes(details: Water), Additional Information: -(2) Medicine Name: Mamajjak , Reference: Government of India, Ministry of Health and Family Welfare. (2008). The Ayurvedic Pharmacopoeia of India (Part 1, Vol. 6, Monograph No. [insert number]). New Delhi: Department of AYUSH., Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 79 Days, anupAna/sahapAna: Yes(details: Water), Additional Information: -(3) Medicine Name: Upkunchika , Reference: Government of India, Ministry of Health and Family Welfare. (2001). The Ayurvedic Pharmacopoeia of India (Part 1, Vol. 1, Monograph No. 74). New Delhi: Department of AYUSH., Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 79 Days, anupAna/sahapAna: Yes(details: Water), Additional Information: -
5
Intervention Arm
Procedure
-
aBya~ggaH, अभ्यंग
(Procedure Reference: Acharya, Y. T. (2011). Charaka Samhita of Agnivesha with Ayurveda Dipika commentary of Chakrapanidatta. Varanasi, India: Chaukhambha Orientalia, Procedure details: Abhyanga will be done with Atibala taila ) (1) Medicine Name: Atibala , Reference: Chunekar, K. C., & Pandey, G. S. (2010). Bhavaprakasha Nighantu. Varanasi, India: Chaukhambha Bharati Academy., Route: Topical, Dosage Form: Taila, Dose: 50(ml), Frequency: od, Duration: 26 Days
Inclusion Criteria
Age From
18.00 Year(s)
Age To
70.00 Year(s)
Gender
Both
Details
1.Patients between the age group of eighteen to seventy years of both genders will be selected.
2.Patients with fasting blood sugar from one hundred twenty six milligrams per deciliter or postprandial blood sugar from two hundred milligrams per deciliter, with HbA1C level more than six point five percent.
ExclusionCriteria
Details
1.Female patients who are pregnant or in the lactating period.
2.Patients aged less than eighteen years and more than seventy years.
3.Patients with HbA1C level more than eight point five percent.
4.Insulin dependent patients.
5.Patients with genetic syndromes associated with type two diabetes mellitus such as Down syndrome, Klinefelter syndrome, and Turner syndrome.
6.Patients having complications of diabetes such as nephropathy, neuropathy, retinopathy, carbuncles, and related conditions.
7.Patients with associated diseases that affect the outcome or completion of the treatment, such as cardiovascular disorders, autoimmune disorders, diabetic foot ulcer or gangrene, cancer, and kidney or liver disorders.
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
1.Fasting blood sugar value equal to or more than one hundred twenty six milligrams per deciliter.
2.Postprandial blood sugar value equal to or more than two hundred milligrams per deciliter.
3.Urine sugar ranging from positive to strongly positive.
4.Glycosylated hemoglobin or HbA1c level equal to or more than six point five percent.
5.Prabhuta Mutrata
Normal urine output up to one thousand five hundred milliliters per day, with mild to severe increase ranging up to more than three thousand milliliters per day.
6.Avila Mutrata
Urine sugar ranging from absent to severe presence.
7.Kshudhadhikya
Appetite varying from usual intake to markedly increased intake with frequent meals and snacks.
8.Trishnadhikya
Water intake ranging from normal to excessive, exceeding three liters per day.
9.Daurbalya
Ability to perform activities ranging from normal routine work to inability to perform even mild exercise.
Baseline and after 2 weeks
Secondary Outcome
Outcome
TimePoints
1.Fasting blood sugar value equal to or more than one hundred twenty six milligrams per deciliter.
2.Postprandial blood sugar value equal to or more than two hundred milligrams per deciliter.
3.Urine sugar ranging from positive to strongly positive.
4.Glycosylated hemoglobin or HbA1c level equal to or more than six point five percent.
5.Prabhuta Mutrata
Normal urine output up to one thousand five hundred milliliters per day, with mild to severe increase ranging up to more than three thousand milliliters per day.
6.Avila Mutrata
Urine sugar ranging from absent to severe presence.
7.Kshudhadhikya
Appetite varying from usual intake to markedly increased intake with frequent meals and snacks.
8.Trishnadhikya
Water intake ranging from normal to excessive, exceeding three liters per day.
9.Daurbalya
Ability to perform activities ranging from normal routine work to inability to perform even mild exercise.
Baseline and after 4 weeks
Target Sample Size
Total Sample Size="30" Sample Size from India="30" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
Phase 3/ Phase 4
Date of First Enrollment (India)
09/02/2026
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
09/02/2026
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="1" Months="6" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
The management of Type 2 Diabetes Mellitus in conventional medicine primarily includes long-term use of oral hypoglycemic agents and insulin therapy due to the chronic, progressive, and relapsing nature of the disease. Prolonged administration of these therapies is often associated with adverse effects such as hypoglycemia, weight gain, gastrointestinal disturbances, and organ-related complications. Therefore, there is a growing need to explore alternative treatment approaches that can provide effective glycemic control while reducing long-term drug-related adverse effects. In individuals with Type 2 Diabetes Mellitus, a wide spectrum of clinical features and metabolic abnormalities may manifest at different stages of the disease. Hence, considering the multifactorial pathogenesis and variable clinical presentation, the present study has adopted a multi-dimensional Ayurvedic management approach to evaluate its impact on patients with Type 2 Diabetes Mellitus.