Effect of two medicines, Vijaysaradi Ghanvati and Madhumehari Vati in the treatment of Madhumeha (Type 2 Diabetes )

Phase 4

Completed

Conditions: Type 2 diabetes mellitus without complications, (2) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,

Registration Number: CTRI/2017/05/008618

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

Brief Summary: Total 60 patients of *Madhumeha* were registered for study, selected patients were divided in two groups on the basis of computer generated randomization.

Group A - *Vijaysardi* *Ghanvati* was given 2 *Vati* (500 mg each) TDS for a duration of 8 weeks with plain water before meal.

Group B - *Madhumehari* *Vati* was given 1 tablet (1000mg) TDS for a duration of 8 weeks with plain water before meal.

**Effect of therapy:**

*Prabhutmutrata* was reduced by 80%in both groups, which was statistically significant significant.

*Pindikodwestan* was reduced by 92% and 81.93% in Group A and B respectively Both the groups had provided statistically significant improvement on *Pindikodwestan.*

*KaraPada Daha* was reduced by 89% and 92.30% in Group A and B respectively. Both the groups had provided statistically significant improvement on *KaraPada Daha.*

*Kshudadhikya* was reduced by 64.3% and 39.75%in Group A and B respectively. Both the groups had provided statistically significant improvement on *Kshudadhikya.*

*KaraPada Supti* was reduced by 90% and 90.44%in Group A and B respectively. Both the groups had provided statistically significant improvement on *KaraPada Supti.*

*Ati-pipasa* was reduced by 64% and 69.38%in Group A and B respectively. Both the groups had provided statistically significant improvement on *Ati-pipasa.*

*Sweda Adhikya* was reduced by 60% and 39.75%in Group A and B respectively. Both the groups had provided statistically significant improvement on *Sweda Adhikya.*

*Guru Gatrata*was reduced by 90% and 100%in Group A and B respectively. Both the groups had provided statistically significant improvement on *Guru Gatrata.*

*Nindradhikya* was reduced by 47.5% and 58.90%in Group A and B respectively.. Both the groups had provided statistically significant improvement on *Nindradhikya**.*

Group-A and Group-B showed 11.52% and 12.16 reductions in FBS respectively, which was significant in both groups.

Group-A and Group-B showed 12.66% and 18.55% reduction in PPBS respectively. Reduction in PPBS in Group-A was significant but it was highly significant in Group-B.

Group-A and Group-B showed 2.56% and 11.47% reduction in HbA1C respectively. Reduction in HbA1C in Group-A was insignificant but it was significant in Group-B.

Group-A and Group-B showed 10.44% and 54.86% decrease in fasting Urine sugar respectively, which was insignificant in Group**-**A but significant in Group**-**B.

**Overall effect of therapy:**

In Group A, complete remission was observed in 3 (11%) patient, markedly improvement was observed in 5 (19%) patients, moderate improvement was observed in 16 (59%) patients, mild improvement was observed in 3 (11%) patients. In Group B, complete remission was observed in 4 (13.5%) patient, markedly improvement was observed in 8 (28%) patients, moderate improvement was observed in 13 (45%) patients, mild improvement was observed in 4 (13.5%) patients.

Ã˜ On analyzing the data overall Group**-**B (*Madhumehari* *Vati*) showed better results than Group**-**A (*Vijaysaradi* *Ghanvati* Group).

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 60

Inclusion Criteria

Patients having signs and symptoms of Madhumeha (Type 2 Diabetes) 2.
Fasting plasma glucose â‰¥ 126 mg/dl or Post Prandial glucose level â‰¥ 200 mg/dl.

Exclusion Criteria

Age less than 20 years more than 70 years.
Patients of Diabetes mellitus receiving Insulin.
Patients having chronic complications of Diabetes mellitus like Retinopathy, Neuropathy Nephropathy, Coronary artery disease, Peripheral vascular disease, Cerebro-vascular disease and other chronic debilitating disease like STD etc.
pregnant and lactating women.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
efficacy	2 month

Secondary Outcome Measures

Name	Time	Method
safety	2 month

Trial Locations

Locations (1): IPGT and RA
🇮🇳
Jamnagar, GUJARAT, India
IPGT and RA
🇮🇳Jamnagar, GUJARAT, India
Dr Sachin Kumar Sharma
Principal investigator
8005304584
sachin.s.dr@gmail.com