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CTRI Number  CTRI/2023/07/055416 [Registered on: 20/07/2023] Trial Registered Prospectively
Last Modified On: 19/07/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Diagnostic
Preventive 
Study Design  Single Arm Study 
Public Title of Study   Triphaladi Kwatha will be given to patients of Diabetes mellitus. 
Scientific Title of Study   Clinical Evaluation of Triphaladi Kwatha in Madhumeha (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  Arun Verma 
Designation  PG Scholar 
Affiliation  UTTARAKHAND AYURVEDA UNIVERSITY GURUKUL CAMPUS HARIDWAR 
Address  Department of Kayachikitsa OPD 05 Uttarakhand Ayurveda University Gurukul Campus Haridwar

Hardwar
UTTARANCHAL
249404
India 
Phone  9219074978  
Fax    
Email  arunverma222111@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Punita Pandey 
Designation  Professor 
Affiliation  UTTARAKHAND AYURVEDA UNIVERSITY GURUKUL CAMPUS HARIDWAR 
Address  OPD 05 Department of Kayachikitsa Uttarakhand Ayurveda University Gurukul Campus Haridwar
OPD 05 Department of Kayachikitsa Uttarakhand Ayurveda University Gurukul Campus Haridwar
Hardwar
UTTARANCHAL
249404
India 
Phone  9319394485  
Fax    
Email  pandey.punita62@gmail.com  
 
Details of Contact Person
Public Query  
Name  ARUN VERMA 
Designation  PG SCHOLAR 
Affiliation  UTTARAKHAND AYURVEDA UNIVERSITY GURUKUL CAMPUS HARIDWAR 
Address  Department of Kayachikitsa OPD 05 Uttarakhand Ayurveda University Gurukul Campus Haridwar

Hardwar
UTTARANCHAL
249404
India 
Phone  9219074978  
Fax    
Email  arunverma222111@gmail.com  
 
Source of Monetary or Material Support  
Arun Verma OPD 05 Department of Kayachikitsa Uttarakhand Ayurveda University Gurukul Campus Haridwar 
 
Primary Sponsor  
Name  Arun Verma 
Address  OPD 05 PG DEPARTMENT OF KAYACHIKITSA UTTARAKHAND AYURVEDA UNIVERSITY GURUKUL CAMPUS HARIDWAR 
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 
Arun Verma  Uttarakhand Ayurveda University Gurukul Campus Haridwar  OPD 05 Department of Kayachikitsa Uttarakhand Ayurveda University Gurukul Campus Haridwar
Hardwar
UTTARANCHAL 		 9219074978

arunverma222111@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC UAU Gurukul Campus Haridwar  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: Triphaladi kwatha, Reference: Charaka Samhita, Sutrasthana,23/10,11, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Samudga, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: NOT ANY
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patient willing to sign the consent form
Patients between the age group of 20-70 years
Fasting blood glucose level
(FBS)≥126mg/dl≤350mg/dl
Post Prandial blood sugar level
(PPBS)≥200mg/dl≤450mg/dl
HbA1c≥6.5%≤13%. 
 
ExclusionCriteria 
Details  Patients of type 1 Diabetes Mellitus
Age below 20years and above 70 years
Blood sugar- fasting blood sugar level>350mg/dl
Post Prandial blood sugar level>450mg/dl
Patients having complications
Patients suffering from any serious medical or
surgical illness 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1) PRABHUTA MUTRATA (Excessive Urination)
2) AVILMUTRATA (Turbidity in Urine)
3) KSHUDHA-ADHIKA (Excessive Hunger)
4) PIPSAS ADHIKA (Excessive Thirst)
5) KARA PADA DAHA (Burning Sensation of Hands & Feet)
6) DAURBALYA (Weakness) 		 Assessment will be done every 15th day and the patients
will be followed up on 7th day and 14th day after completion of trial 
 
Secondary Outcome  
Outcome  TimePoints 
• BLOOD SUGAR- FASTING
• BLOOD SUGAR-POST PRANDIAL
• HbA1c
• URINE SUGAR
• BODY WEIGHT
• BMI 		 At 1st & 90th day. 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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   N/A 
Date of First Enrollment (India)   29/07/2023 
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="9"
Days="10" 
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   This study is open label clinical trial to determine the efficacy of Triphaladi kwatha in Madhumeha ( Diabetes mellitus) for age group between 20-70 years, daily for 90 days. The study will be conducted at UAU gurukul campus, Haridwar on 40 patients. The assessment will be done on the basis of subjective and objective parameters. The study will be conducted at OPD/IPD level of P.G department of kayachikitsa. The assessment will be done at the interval of 15 days of the clinical trial and the results obtained will be tabulated and statically analyzed using appropriate tests. 
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