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CTRI Number  CTRI/2016/03/006769 [Registered on: 30/03/2016] Trial Registered Retrospectively
Last Modified On: 24/04/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Pharmaceutical standardization of saptarangyadi vati prepared by two methods and their comperative effect on MADHUMEHA(TYPE-2 DIABETIS MELLITUS) 
Scientific Title of Study   Pharmaceutical standardization of saptarangyadi vati prepared by two methods and their comparative effect on MADHUMEHA(TYPE-2 DIABETIS MELLITUS) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Monika katiyar 
Designation  M D second year scholar 
Affiliation  IPGT RA jamnagar 
Address  P G Girls hostel IPGT RA jamnagar room no 307
P G Girls hostel IPGT RA Jamnagar room no 307
Jamnagar
GUJARAT
361008
India 
Phone  9621184411  
Fax  028826768565  
Email  Monika.katiyar1@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof P K Prajapati 
Designation  Director ipgtra 
Affiliation  IPGT RA jamnagar 
Address  Ipgtra Gau jamnagar
Ipgtra Gau jamnagar
Jamnagar
GUJARAT
361008
India 
Phone  9978403323  
Fax  028826768565  
Email  Prajapati.pradeep1@gmail.com  
 
Details of Contact Person
Public Query  
Name  Monika katiyar 
Designation  M D second year scholar 
Affiliation  IPGT RA jamnagar 
Address  P G Girls hostel IPGT RA jamnagar room no 307
P G Girls hostel IPGT RA Jamnagar room no 307
Jamnagar
GUJARAT
361008
India 
Phone  9621184411  
Fax  028826768565  
Email  Monika.katiyar1@gmail.com  
 
Source of Monetary or Material Support  
Gujarat Ayurved university 
 
Primary Sponsor  
Name  Institute ipgt ra 
Address  Ipgt ra Gujarat Ayurveda university jamnagar 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Monika Katiyar  opd and ipd ipgtra gujarat ayurvesd university  Opd no 13 rsbk deptipgtra gujarat ayurvesd university
Jamnagar
GUJARAT 		 9621184411

monika.katiyar1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ipgtra institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  With sign and symptoms if disease otherwise healthy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Saptarangyadi Ghana vati(method 1)  Pharmacy Gujarat Ayurveda university anubhut 
Comparator Agent  saptrangyadi ghana vati(method 2)  Prepared at pharmacy gujarat ayurved university(anubhut) two tablets of 500mg of saptarangyadi ghana vati will be administered to patient twice a day with luke worm water for 8 weeks  
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  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 ≥ 126 mg/dl and Post prandial glucose level ≥ 200 mg/dl. 
 
ExclusionCriteria 
Details  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.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
will be generated  before and after treatment 
 
Secondary Outcome  
Outcome  TimePoints 
will be generated  before and after treatment 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   21/03/2016 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="4"
Days="15" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  		 study completed and published 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  		 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 is a development of Kwatha Kalpana and has its roots in Brihatrayee and Saptarangyadi Ghana is an anubhuta yoga,frequently used in Madhumeha.

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

3. Based upon Analytical parameters, it can be concluded that Ghana prepared from

Kwatha is more 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, and enjyme inhibitory activity. Both the samples exhibited weak anti-hyperglycaemic, anti-diabetic, enjyme inhibitory activity but SGV-B was found to produce slightly better effect in comparison to SV-A.

5. In clinical trials, Saptarangyadi Ghanavati (SGV-B) found to be better in comparison to 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 is a development of Kwatha Kalpana and has its roots in Brihatrayee and Saptarangyadi Ghana is an anubhuta yoga,frequently used in Madhumeha.

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

3. Based upon Analytical parameters, it can be concluded that Ghana prepared from

Kwatha is more 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, and enjyme inhibitory activity. Both the samples exhibited weak anti-hyperglycaemic, anti-diabetic, enjyme inhibitory activity but SGV-B was found to produce slightly better effect in comparison to SV-A.

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




 
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