Health Condition 1: E888- Other specified metabolic disorders
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Willing to provide informed written consent. 2. BMI more than or equals to 23 kg per m2 3. Impaired fasting plasma glucose more than or equals to 100mg per dl or PP(2h) and blood glucose random more than or equals to 140mg per dl or HbA1c more than or equals to 5.7 percent 4. Impaired fasting triglycerides more than or equals to 150mg per dl 5. Blood pressure more than or equals to 140 over 90 mm of Hg 6. Diagnosed with insulin resistance, defined by elevated TyG-BMI index (based on TyG-BMI Quartiles). 7. Those already taking medications that directly alter insulin resistance (e.g., metformin, pioglitazone, statins, corticosteroids, weight-loss drugs) still TyG-BMI index is high. 8. Willing and able to comply with treatment, follow-up visits, and protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Patients unwilling to provide informed written consent or unable to follow up regularly or comply with the protocol. 2. Patients with clinically unstable or advanced organ diseases. 3. Pregnant or lactating women, due to hormonal effects and ethical limitations. 4. Patients with acute infections, ongoing febrile illnesses, or current hospitalization. 5. Individuals with substance abuse, severe psychiatric illness, or cognitive impairment affecting compliance. 6. Known allergy to Crataegus or Berberis preparations. 7. Participants enrolled in any other clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PARTICIPANTS RECEIVING HOMOEOPATHIC MOTHER TINCTURES ALONG WITH INDIVIDUALIZED HOMOEOPATHIC MEDICINES ARE EXPECTED TO SHOW A GREATER REDUCTION IN TYG-BMI INDEX COMPARED TO THOSE RECEIVING INDIVIDUALIZED HOMOEOPATHIC TREATMENT ALONETimepoint: PRE- AND POST-SCORES WILL BE ASSESSED BASED ON ALTERATIONS IN TYG-BMI VALUES ACROSS QUARTILES (Q1?Q4) AT THE END OF 3 MONTHS | — |
Secondary
| Measure | Time frame |
|---|---|
| AT THE END OF STUDY WE EXPECT THAT CRATAEGUS OXYACANTHA AND BERBERIS VULGARIS HOMOEOPATHIC MOTHER TINCTURES NOT ONLY MANAGED INSULIN RESISTANCE BUT ALSO ITS COMORBIDITIESTimepoint: 12 MONTHS;MOTHER TINCTURE DOSES ARE EMPIRICALLY DERIVED AND NOT YET RIGOROUSLY VALIDATED; THEREFORE, THIS STUDY WILL CONTRIBUTE TOWARD DOSE VALIDATION. THE TRIAL IS EXPECTED TO GENERATE DATA TO SUPPORT FUTURE DOSE?RESPONSE EVALUATIONS AND FACILITATE EVIDENCE-BASED REFINEMENT OF MOTHER TINCTURE USE IN HOMOEOPATHY AS AN ADD-ON THERAPY.Timepoint: 12 MONTHS | — |
Countries
India
Contacts
Dr MPK HOMOEOPATHIC MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE