Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
None listed
Sponsors
Parul Institute of Ayurved
Eligibility
Inclusion criteria
Inclusion criteria: 1. Female participants aged 40 to 65 years. (To target women in the perimenopausal phase.) 2. Diagnosed with Type 2 Diabetes Mellitus as per American Diabetes Association (ADA) or equivalent standard clinical criteria. 3. HbA1c levels between 6.5% and 9% at the time of screening. (To include those with mild to moderate glycemic imbalance.) 4. Experiencing clinical features of perimenopause, such as: Irregular menstrual cycles Hot flashes Mood swings Sleep disturbances 5. Willingness to undergo Takrabasti and Shirodhara procedures as per the study protocol. 6. On stable oral hypoglycemic therapy (if any) for at least the past 3 months, with no anticipated changes during the study period 7. Able to give written informed consent 8. Willing and able to comply with study procedures, follow-up visits, and Ayurvedic treatment regimen.
Exclusion criteria
Exclusion criteria: 1. Women below 40 or above 65 years of age. To ensure the population is limited to the perimenopausal age range 2. Known cases of Type 1 Diabetes Mellitus or secondary diabetes. 3. History of surgical menopause hysterectomy with bilateral oophorectomy 4. Patients on insulin therapy or other non-oral hypoglycemic drugs. 5. Use of hormone replacement therapy HRT in the last 3 months. 6. Severe diabetic complications such as Diabetic nephropathy Diabetic retinopathy Diabetic foot ulcers Severe peripheral neuropathy 7. Uncontrolled hypertension more than160/100 mmHg 8. Chronic systemic illnesses such as Chronic kidney disease (CKD) Liver cirrhosis Congestive heart failure Active tuberculosis or HIVorAIDS 9. Psychiatric illness or cognitive impairment affecting ability to consent or follow the study protocol. 10. Women currently participating in another clinical trial. 13. Known allergy or intolerance to any components used in Takrabasti or Shirodhara procedures. 13. Presence of active infections or febrile illness at the time of screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To assess the effect of Takrabasti Protocol A on fasting blood glucose, postprandial blood glucose, and HbA1c levels in perimenopausal women with T2DM.And To assess the effect of Takrabasti Protocol B on the same glycemic parameters in a comparable group.Timepoint: 8 days of Treatment (basti chikitsa + shirodhara) 16th day followup Biochemical: FBS, PPBS, HbA1c, insulin resistance. Hormonal: Estradiol.If needed. Metabolic: Lipid profile, BMI, waist-hip ratio,CRP symptoms of perimenopausal women with diabeties mellitus. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the additional impact of Shirodhara in reducing stress and improving hormonal balance, which may influence glycemic control. Timepoint: 8days of treatment;To compare the overall therapeutic outcomes between the two Takrabasti protocols in terms of glycemic control, clinical symptoms, and quality of life and to investigate the safety, tolerability, and patient compliance of both treatment protocols Timepoint: 8days treatment | — |
Countries
India
Contacts
Public ContactDr Mauli Vaishnav
Parul Institute of Ayurved
Outcome results
None listed