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CTRI Number  CTRI/2024/09/073437 [Registered on: 05/09/2024] Trial Registered Prospectively
Last Modified On: 03/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A clinical trial to study the effectiveness of the selected ayurvedic formulation- Vallipanchamoola choorna in Type 2 Diabetes Mellitus. 
Scientific Title of Study   Effectiveness of Valli panchamoola choorna in Type 2 Diabetes Mellitus  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Dineesha M 
Designation  PG Scholar , Department of Kayachikitsa 
Affiliation  Govt Ayurveda Medical College And Hospital Trivandrum 
Address  PG Scholar Govt Ayurveda Medical College and Hospital Ayurveda College Junction Trivandrum,Kerala,India,695001

Thiruvananthapuram
KERALA
695001
India 
Phone  9497039916  
Fax    
Email  dineesha5455@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dineesha M 
Designation  PG Scholar , Department of Kayachikitsa 
Affiliation  Govt Ayurveda Medical College And Hospital Trivandrum 
Address  PG Scholar Govt Ayurveda Medical College and Hospital Ayurveda College Junction Trivandrum,Kerala,India,695001

Thiruvananthapuram
KERALA
695001
India 
Phone  9497039916  
Fax    
Email  dineesha5455@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Mini V G 
Designation  Professor ,Department Of Kayachikitsa 
Affiliation  Govt Ayurveda Medical College And Hospital Trivandrum 
Address  Govt Ayurveda Medical College and Hospital Ayurveda College Junction Trivandrum,Kerala,India,695001

Thiruvananthapuram
KERALA
695001
India 
Phone  9446380592  
Fax    
Email  mini.tinku@gmail.com  
 
Source of Monetary or Material Support  
Govt Ayurveda Medical College and Hospital, Ayurveda College Junction Trivandrum,Kerala,India,695001  
 
Primary Sponsor  
Name  Dr Dineesha M 
Address  PG Scholar Govt Ayurveda Medical College and Hospital Ayurveda College Junction Trivandrum,Kerala,India,695001 
Type of Sponsor  Other [Self] 
 
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 
Dr Dineesha M  Govt Ayurveda Medical College and Hospital  Department of Kayachikitsa (OP Number 2) Govt Ayurveda Medical College and Hospital Trivandrum Kerala,India,695001
Thiruvananthapuram
KERALA 		 9497039916

dineesha5455@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee (IEC),Govt Ayurveda College Trivandrum,Kerala,India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: PRAMEHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: VALLI PANCHAMOOLA CHOORNA, Reference: SUSRUTA SAMHITHA-DRAVYA SANGRAHANEEYA ADHYAYA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: USHNA JALA), Additional Information: -
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Male and female participants of age group 30 to 65 years.
FBS(Fasting Blood Sugar)- 126 mg/dl to 200 mg/dl.
PPBS(Post Prandial Blood Sugar)- 200 mg/dl to 300 mg/dl
HbA1C-6.5% to 9%
 
 
ExclusionCriteria 
Details  Those who are under insulin therapy and under other active and continuous medications for Type 2 Diabetes Mellitus.
Diagnosed case of drug induced Type 2 Diabetes Mellitus
Women who are pregnant, lactating and planning to get pregnant.
Diagnosed cases of diabetes with established features of nephropathy and retinopathy.
Patients with severe cardiac, pulmonary, hepatic disorders and neoplasms.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Changes in the following blood parameters:
1)FBS  		 OTH DAY
30TH DAY
60TH DAY
91ST DAY 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in the following blood parameters:
1)PPBS 		 0TH DAY
91ST DAY 
Changes in the following blood parameters:
1)HbA1c 		 0 th DAY
91ST DAY 
 
Target Sample Size   Total Sample Size="26"
Sample Size from India="26" 
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 3/ Phase 4 
Date of First Enrollment (India)   14/09/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Diabetes Mellitus is a major health endemic affecting mankind since ancient times. It is a well- known multifactorial metabolic disorder characterized by abnormally high blood glucose levels due to absolute or relative lack of insulin. The incidence of Diabetes has increased drastically in the recent times because of sedentary lifestyle and unhealthy dietary habits, which happens to be the main etiological factors for this disease. Type 2 Diabetes Mellitus makes up about 90% of global cases of Diabetes. Diabetes accounts for about 4.6 million deaths world wide every year and is projected by WHO to be the 7th leading cause of death by 2030. India currently represents 49% of the world’s diabetes burden.
Diabetes mellitus can be correlated to Prameha in Ayurveda classics.It is one among the Ashtamahagada. In Prameha, kaphapradhana tridosha dushti occurs. The dushyas involved are Medas, Mamsa, Rasa, Raktha, Majja, Sukra, Vasa, Lasika and Ojus.
The present study has been undertaken to evaluate the efficacy of ‘Vallipanchamoola choorna’ in managing Type II Diabetes Mellitus. Vallipanchamoola is mentioned in Susruta Samhitha Sutrasthana- “Dravya sangrahaneeya adhayaya”.Valli Panchamoola drugs are best for kaphanashana, srushtamutranilahara, vrushyam and indriya bodhanam.
The study is an interventional study with pre and post-test without control group.
A total of 26 participants of all genders aged 30 to 65 years registered in the OPD of Govt Ayurveda College Trivandrum satisfying the inclusion criteria will be selected for the study. The data will be collected through observations and lab investigations(FBS,PPBS and HbA1C).The medicine will be prepared as per the classical reference.
The selected participants will be given Vallipanchamoola choornam 6 grams twice daily,one hour before food, with lukewarm water for 90 days and review will be done after every 15 days. Assessment will be done on 0th , 30th ,60th and 91st days with subjective and objective parameters. The results will be analysed statistically,then summarized and conclusions will be made on the clinical effectiveness of the given drug.
 
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