Effect of Abhraka Bhasma Amrutikarana in type 2 diabetes

Completed

Conditions: Type 2 diabetes mellitus without complications. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH,

Registration Number: CTRI/2021/02/031095

Lead Sponsor: Institute for Post Graduate Teaching and Research in Ayurveda

Brief Summary: Indian population with type 2 diabetes has a high burden (76.6%) of poorglycemic control. In Ayurveda Diabetes mellitus is compared with *Madhumeha*and classified under *Vataja Prameha.**Abhraka* is a wonder drugdescribed under Rasashastra branch with predominant *Rasayana* and *Yogavahi*properties. *Abhraka* is mostly prescribedin the form of *Bhasma* after several processing steps like *Shodhana,Dhanyabhraka Nirmana, Marana, Amrutikarana* etc. *Amrutikarana*is a special procedure to eliminate all remaining *Doshas* from theprepared *Bhasma* without impairing the therapeutic efficacy of the endproduct. Since no previous research works has been found for the revalidationof this fact in therapeutic efficacy of *Abhraka Bhasma* in diabetes,hence present research work is an effort to establish a link between the effectof *Amrutikarana* and therapeutic efficacy of *Abhraka Bhasma* in *Madhumeha.**Abhraka Bhasma* will be prepared by 60 cycles of incineration and then Amrutikarana will be carried out in one group. Then clinical study will be carried out in type 2 diabetes (Madhumeha) patients.

Treatment group 1: 1 Tablet (187.5 mg Abhraka Bhasma prepared with Amrutikarana and 62.5 mg Triphala Ghana) twice daily

Treatment group 2: 1 Tablet (187.5 mg Abhraka Bhasma prepared without Amrutikarana and 62.5 mg Triphala Ghana) twice daily

Dose: 187.5 mg BD

Adjuvant: Water in sufficient quantity

Time of administration: 15 min before meal

Study duration: 8 weeks

Follow up: 4 weeks

Concurrent medications or treatments for diabetes: Patients on continuedmedication from any medical system will be allowed to continue theirmedications during the treatment and follow up period (except insulin). Theresearch drug will be on addon basis during the treatment period. If patienthas no previous drug history, he/she will receive the research drug only.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 102

Inclusion Criteria

Either the sexes having age between 18 to 60 years.
Patients having chief & associated complains of Madhumeha (Prabhuta-Avilamutrata, pipashadhikya, kshudhadhikya etc.) Patients with stable continuous dose of modern medicine for more than 1 month.
Known patient of Type 2 Diabetes and also the preliminarily diagnosed patients on the basis of signs and symptoms of the disease are confirmed by FBS and PPBS.

Exclusion Criteria

Age more than 60 and below18 years Prameha pidika (Diabetic nonhealing wound), Systemic infection, active infection other than superficial mild skin infestation Secondary Diabetes mellitus and Diabetes mellitus Type 1 Patients of any other severe illness.
Malignant and accelerated hypertensive.
Other chronic debilitating diseases.
Pregnant woman and expecting conception (within six month) Lactating mothers.
Patients with fatal diabetic complication like end stage renal disease Patient with diabetic ketoacidosis Severe anaemia below 7gm% Hb.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Control in blood sugar level and symptomatic relief	2 months

Secondary Outcome Measures

Name	Time	Method
Improved quality of life	2 months

Trial Locations

Locations (1): Institute for Post Graduate Teaching and Research in Ayurveda
🇮🇳
Jamnagar, GUJARAT, India
Institute for Post Graduate Teaching and Research in Ayurveda
🇮🇳Jamnagar, GUJARAT, India
Om Pandey
Principal investigator
8004801212
dr.ompandey07@gmail.com