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CTRI Number  CTRI/2025/03/082230 [Registered on: 12/03/2025] Trial Registered Prospectively
Last Modified On: 03/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of ayurveda in the Management of Madhumeha (Type 2 Diabetes Mellitus) 
Scientific Title of Study   Efficacy of Kaishore Guggulu and Asanadi Kwatha in the management of newly diagnosed cases of Madhumeha w.s.r Type 2 diabetes mellitus : an open-label randomized comparative parallel group study 
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 Ayush Gupta 
Designation  PG SCHOLAR 
Affiliation  Ayurvedic and Unani Tibbia College and Hospital 
Address  Ayurvedic and Unani Tibbia College and Hospital, PG Dept of Kayachikitsa, Karol Bagh, New Delhi

Central
DELHI
110005
India 
Phone  8299560656  
Fax    
Email  dr.ayush2805@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sujata Yadav 
Designation  Associate Professor and Head of Department 
Affiliation  Ayurvedic and Unani Tibbia College and Hospital 
Address  Ayurvedic and Unani Tibbia College and Hospital, PG Dept of Kayachikitsa, Karol Bagh, New Delhi

Central
DELHI
110005
India 
Phone  9810571653  
Fax    
Email  sujatakcdelhi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sujata Yadav 
Designation  Associate Professor and Head of Department 
Affiliation  Ayurvedic and Unani Tibbia College and Hospital 
Address  Ayurvedic and Unani Tibbia College and Hospital, PG Dept of Kayachikitsa, Karol Bagh, New Delhi

Central
DELHI
110005
India 
Phone  9810571653  
Fax    
Email  sujatakcdelhi@gmail.com  
 
Source of Monetary or Material Support  
Ayurvedic and Unani Tibbia College and Hospital, Karol Bagh, New Delhi-110005 
 
Primary Sponsor  
Name  Ayurvedic and Unani Tibbia College and Hospital 
Address  Ayurvedic and Unani Tibbia College and Hospital,Karol Bagh, New Delhi-110005  
Type of Sponsor  Government medical college 
 
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 Sujata Yadav  Ayurvedic and Unani Tibbia College and Hospital  Seminar Room,PG Department of Kayachikitsa Central DELHI
Central
DELHI 		 9810571653

sujatakcdelhi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC Ayurvedic and Unani Tibbia college and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E11||Type 2 diabetes mellitus. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Kaishore Guggulu, Reference: Sharangdhar Samhita, Route: Oral, Dosage Form: Guggulu , Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 12 Weeks, anupAna/sahapAna: Yes(details: -Lukewarm Water), Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Asanadi Kwatha, Reference: Vangasena Samhita, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 12 Weeks, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients of any gender aged 35 to 65 years diagnosed with Type 2 DM.
Fasting Blood sugar 126-179 mg/dl.
Glycosylated Hemoglobin (HbA1c) 6.5- 7.9%
Subjects willing to provide written informed consent and able to come for follow
up on scheduled visits. 
 
ExclusionCriteria 
Details  Individuals diagnosed with type 1 DM.
Subjects not taking any oral hypoglycemic drugs or insulin therapy.
Individuals with type 2 DM with poor control (HbA1C greater than or equal to 8 %).
Subjects suffering from the acute and chronic complications of Diabetes mellitus viz.,
diabetic neuropathy, diabetic nephropathy, diabetic retinopathy, diabetes ketoacidosis,
hyperglycemic coma, peripheral artery disease, etc. which require emergency
management.
Subjects with history of any cardiovascular disease such as coronary artery disease,
congestive heart failure, Hypertension, valvular heart disease , etc.
Subjects with comorbidities such as Bronchial Asthma, COPD, Cerebrovascular
Accident, tuberculosis, etc.
Subjects having immunocompromised state such as HIV or taking any
immunosuppressive medications.
Subjects with history or active malignancy.
Subjects suffering from any major systemic illness necessitating long term treatment
like Rheumatoid arthritis, psychiatric disorders, and endocrinal disorders.
Subjects on corticosteroids, beta agonist, estrogen, progestins, antidepressants,
antipsychotics etc that may affect glucose metabolism.
Subject suffering from any hepatic disorder (SGPT and SGOT more than two times the upper limit of normal)
Subjects suffering from chronic kidney disease or any renal disorder (serum creatinine greater than 1.2 mg/dL).
Pregnant and lactating women.
Subjects taking medicines from any other traditional medicine systems for type 2 DM.
Subjects with a history of smoking, alcohol intake or any substance abuse.
Subjects having hypersensitivity to any of the trial interventions or their ingredients.
Subjects who have completed participation in any other clinical trial during the past six
months.
Any other clinical condition which may compromise the safety of the individual / study
participant. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in fasting blood sugar and post prandial blood sugar from baseline .  Day 1, 91 
 
Secondary Outcome  
Outcome  TimePoints 
Change in HbA1C from baseline.
 		 Day 1, 91 
Change in health related quality of life assesed through SF12 questionnaire   Day 1, 91 
Change in grading of symptoms of Madhumeha assessed through “Developing
guidelines for clinical research methodology in Ayurveda” 		 Day 1, 91 
Incidence of adverse events if any.  Day 1, 91 
Change in the laboratory safety parameters (LFT ,KFT, CBC , Lipid profile) from
baseline.  		 Day 1, 91 
 
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 2/ Phase 3 
Date of First Enrollment (India)   24/03/2025 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - 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

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  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) - 

  6. For how long will this data be available start date provided 31-10-2026 and end date provided 31-10-2029?
    Response - Beginning 9 months and ending 36 months following article publication.

  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 hyperglycemia due to reduced insulin secretion, decreased glucose utilization, and increased glucose production. Its symptoms include frequent urination, increased thirst, and hunger. Rising global incidence is linked to reduced physical activity and obesity, with prevalence increasing from 4.7% in 1980 to 8.5% in 2014. According to the International Diabetes Federation, by 2045, 783 million people will have diabetes, with the majority in low- and middle-income countries. Alarmingly, younger age groups and adolescents are increasingly affected. India has the highest number of diabetics globally, earning the title of "diabetic capital of the world."

The aim of this study is to generate preliminary evidence regarding the efficacy and safety of Kaishore Guggulu and Asanadi Kwatha in the management of newly diagnosed mild to moderate cases of Madhumeha (Type 2 diabetes mellitus).

 
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