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CTRI Number  CTRI/2024/07/069893 [Registered on: 04/07/2024] Trial Registered Prospectively
Last Modified On: 02/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical study to compare the effects of Yavanyadi and Nishakathakadi tablets as an add-on medication in patients with Type 2 Diabetes mellitus. 
Scientific Title of Study   Efficacy of Yavanyadi tablet as an add on medication 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  Deepika G I 
Designation  PG scholar 
Affiliation  Govt. Ayurveda College Thiruvananthapuram 
Address  Department of Dravyagunavigyan Govt Ayurveda College Trivandrum Kerala India. 695001

Thiruvananthapuram
KERALA
695001
India 
Phone  9495731397  
Fax    
Email  drdeepikagopinathan@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr A Shahul Hameed 
Designation  Professor and HOD 
Affiliation  Government Ayurveda College Thiruvananthapuram 
Address  Department of Dravyagunavigyan Govt Ayurveda College Trivandrum Kerala India.

Thiruvananthapuram
KERALA
695001
India 
Phone  9495311820  
Fax    
Email  shahulanchal@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Indulekha V C 
Designation  Associate Professor 
Affiliation  Government Ayurveda College Thiruvananthapuram 
Address  Department of Dravyagunavigyan Govt Ayurveda College Thiruvananthapuram

Thiruvananthapuram
KERALA
695001
India 
Phone  9446553068  
Fax    
Email  drindulekha@gmail.com  
 
Source of Monetary or Material Support  
Govt. Ayurveda College Pulimood Junction Thiruvananthapuram 695001 
 
Primary Sponsor  
Name  Dr Deepika GI 
Address  Deepika GI Department of Dravyagunavigyan Govt. Ayurveda College Thiruvananthapuram 
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 Deepika G I  Govt Ayurveda College Thiruvananthapuram  Room No 1 Dravyaguna OP Department of Dravyagunavigyan Govt Ayurveda College Hospital
Thiruvananthapuram
KERALA 		 9495731397

drdeepikagopinathan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee Govt. Ayurveda College  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: MADHUMEHAH/KSHAUDRAMEHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Yavanyadi yogam, Reference: Charaka Samhita Chikitsa sthana 6th chapter sloka number 29, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -warm water), Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Nishakathakadi yoga, Reference: Sahasrayogam, English Translation by Dr G Prabhakar Rao page number 106, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -warm water), Additional Information: -
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1.participants of age group 25-75 years 2.HbA1c greater than 6.5% 3.FBS level from 126mg/dl -250mg/dl or PPBS level from 200mg/dl-400mg/dl 4.Under stable dose of an anti-diabetic therapy.
 
 
ExclusionCriteria 
Details  1.HbA1c greater than 9.5% 2.Diagnosed cases of morbid cardiac & pulmonary HTN, metabolic complications like hyper-osmolar state 3. Pregnant or lactating women
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Changes in blood parameters
1. FBS
2. PPBS
3. HbA1c 		 Baseline,4weeks, 8weeks, 12weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1.For Standardization of the study drug physical parameters like Ash value, extractive value,TLC 2. Changes in Blood parameters of LFT, RFT 3.BMI

 		 Baseline and 90th day 
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
Final Enrollment numbers achieved (Total)= "52"
Final Enrollment numbers achieved (India)="52" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   08/08/2024 
Date of Study Completion (India) 07/08/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  On personal contact via google drive

  6. For how long will this data be available start date provided 08-08-2024 and end date provided 09-04-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  
Diabetes mellitus (DM) is a group of metabolic disorders characterized by a chronic hyperglycemic condition resulting from defects in insulin secretion, insulin action or both. Type 2 DM is marked by high blood sugar, insulin resistance and relative lack of insulin. The affected ones are managed with oral antihyperglycemic drugs, insulin & non-insulin injectable therapy. Diabetes mellitus can be correlated to Madhumeha (A type of Prameha) in Ayurveda. In the classical texts of Ayurveda, several formulations are mentioned in the context of Prameha chikitsa (treatment of Prameha) which are in practice. They are found to have hypoglycemic effects. In Kerala, Nishakathakadi yogam is the conventional Ayurvedic formulation used in T2DM.  Yavanyadi yogam is another polyherbal formulation mentioned in the classical textbook, Charaka Samhita in the treatment of Prameha. The constituents of the formulation are seeds of Yavani (Nigella sativa L), root of Usheera (Vetiveria zizanoides L. Nash), fruit rind of Abhaya (Terminalia chebula Retz.) & stem of Guduchi (Tinospora cordifolia (Willd.) Hook. f. and Thoms.). In the current scientific world, evidence-based approach is given much importance. The patient compliance to Ayurvedic medicines is a major problem in chronic disease management. People usually opt more easier form of drug administration. The medication in tablet form ensures a consistent dose, that is easy to consume. Yavanyadi yogam, is a less scientifically explored formulation in DM. Moreover, all the individual drugs have proven anti-diabetic action, pre-clinically. Hence, the present study is indented to determine the efficacy of Yavanyadi yogam which will be prepared as tablets thrice daily as an add-on medication in T2DM in comparison with Nishakathakadi yogam made into tablet,  in the management of Type 2 Diabetes mellitus.
 
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