Pharmaceutical standardization of saptarangyadi vati prepared by two methods and their comperative effect on MADHUMEHA(TYPE-2 DIABETIS MELLITUS)

Phase 1

Recruiting

Conditions: With sign and symptoms if disease otherwise healthy

Registration Number: CTRI/2016/03/006769

Lead Sponsor: Institute ipgt ra

Brief Summary: Diabetes mellitus is a major cause of morbidity and mortality worldwide with an increasing prevalence of 347 million people in 2013. Diabetes Mellitus comprises a group of common metabolic disorders that share the phenotype of hyperglycemia. On the other hand, complementary and alternative treatment systems have readily gained popularity in treating diabetes over the past few years. Over 1200 plants have been claimed to be remedies for Diabetes mellitus. 1. *Ghana Kalpana* isa development of *Kwatha Kalpana* and has its roots in *Brihatrayee* and*Saptarangyadi Ghana i*s ananubhuta yoga,frequently used in *Madhumeha*.

2.For 3 Kg. of *Saptarangyadi* *Kwatha Churna* (sieve size no. 10), 16times water (48 â„“) should be taken and reduced up to 1/8th(6â„“) to prepare *Kwatha* at 900C-1000C temperature.Again this *Kwatha* should be heated for *Ghana* preparation on 500C-550Ctemperature. It gives avg. 325 g of yield. (avg.16.25%).

3.Based upon Analytical parameters, it can be concluded that *Ghana* preparedfrom

*Kwatha*ismore viable in comparison to *Churna*.

4.The biological activity of *Saptarangyadi Ghana* prepared from *Ghana* (SGV-B)and *Churna*(SV-A), were evaluated on the related parameters like anti-hyperglycaemic, anti-diabetic, andenjyme inhibitory activity. Both the samples exhibited weakanti-hyperglycaemic, anti-diabetic, enjyme inhibitory activity but SGV-B wasfound to produce slightly better effect in comparison to SV-A.

5.In clinical trials, *Saptarangyadi* *Ghanavati* (SGV-B) found to be better in comparisonto *Saptarangyadi* *vati* (SV-A).

Saptarangyadi Vati is one such formulation preferred frequently at OPD and IPD levels of IPGT & RA for Diabetes. It is also planned to prepare the formulation by following the process of Ghana Kalpana and compare the efficacy at pre-clinical and clinical levels. 1. *Ghana Kalpana* isa development of *Kwatha Kalpana* and has its roots in *Brihatrayee* and*Saptarangyadi Ghana i*s ananubhuta yoga,frequently used in *Madhumeha*.2.For 3 Kg. of *Saptarangyadi* *Kwatha Churna* (sieve size no. 10), 16times water (48 â„“) should be taken and reduced up to 1/8th(6â„“) to prepare *Kwatha* at 900C-1000C temperature.Again this *Kwatha* should be heated for *Ghana* preparation on 500C-550Ctemperature. It gives avg. 325 g of yield. (avg.16.25%).

3.Based upon Analytical parameters, it can be concluded that *Ghana* preparedfrom

*Kwatha*ismore viable in comparison to *Churna*.

4.The biological activity of *Saptarangyadi Ghana* prepared from *Ghana* (SGV-B)and *Churna*(SV-A), were evaluated on the related parameters like anti-hyperglycaemic, anti-diabetic, andenjyme inhibitory activity. Both the samples exhibited weakanti-hyperglycaemic, anti-diabetic, enjyme inhibitory activity but SGV-B wasfound to produce slightly better effect in comparison to SV-A.

5.In clinical trials, *Saptarangyadi* *Ghanavati* (SGV-B) found to be better in comparisonto *Saptarangyadi* *vati* (SV-A).

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 60

Inclusion Criteria

Patients having classical symptoms of Type II D.M. (Madhumeha) will be selected from O.P.D. and I.P.D. of I.P.G.T. & R.A. Hospital, Jamnagar.
Both the Genders having age between 30 to 70 years.
Patients having Fasting glucose level â‰¥ 126 mg/dl and Post prandial glucose level â‰¥ 200 mg/dl.

Exclusion Criteria

Patients IDDM.
Uncontrolled cases of Diabetes Patients having chronic complications of Diabetes Microvascular: Retinopathy, Neuropathy & Nephropathy.
Macrovascular: Coronary artery disease, Peripheral vascular disease & Cerebro-vascular disease.
Other chronic debilitating diseases like Tuberculosis, STD etc.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
will be generated	before and after treatment

Secondary Outcome Measures

Name	Time	Method
will be generated	before and after treatment

Trial Locations

Locations (1): opd and ipd ipgtra gujarat ayurvesd university
🇮🇳
Jamnagar, GUJARAT, India
opd and ipd ipgtra gujarat ayurvesd university
🇮🇳Jamnagar, GUJARAT, India
Monika Katiyar
Principal investigator
9621184411
monika.katiyar1@gmail.com