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CTRI Number  CTRI/2024/12/077857 [Registered on: 09/12/2024] Trial Registered Prospectively
Last Modified On: 06/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To see effect of Kantak Panchamool churn in Madhumeh  
Scientific Title of Study   Open randomized control clinical trial of Kantak panchamool churna in Madhumeh with special reference to DM 2 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ankita Shankar Pawar 
Designation  PG Scholar 
Affiliation  Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta 
Address  OPD no 1 Kayachikitsa department

Sangli
MAHARASHTRA
416301
India 
Phone  9167446485  
Fax    
Email  ankitapawar1011@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Smita Lokhande 
Designation  Associate Professor 
Affiliation  Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta 
Address  OPD no 1 Kayachikitsa department

Sangli
MAHARASHTRA
416301
India 
Phone  8149556591  
Fax    
Email  yoshitpriya@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Smita Lokhande 
Designation  Associate Professor 
Affiliation  Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta 
Address  OPD no 1 Kayachikitsa department

Sangli
MAHARASHTRA
416301
India 
Phone  8149556591  
Fax    
Email  yoshitpriya@gmail.com  
 
Source of Monetary or Material Support  
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta tal walwa dist sangli maharashtra india 416301 
 
Primary Sponsor  
Name  Dr Ankita Shankar Pawar 
Address  OPD no 1 Kayachikitsa OPD Ground Floor Dhanvantari Ayurved Hospital Ashta Tal Walwa Dist Sangli Maharashtra India 416301 
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 Ankita Shankar Pawar   Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta  OPD no 1 Kayachikitsa OPD Ground Floor Dhanvantari Ayurved Hospital Ashta Tal Walwa
Sangli
MAHARASHTRA 
9167446485

ankitapawar1011@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta Ethics Committee  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
1Comparator ArmDrugClassical(1) Medicine Name: Kantak Panchamool, Reference: Sushrut samhita Dravya samhaniya adhyay 38/74,75, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Koshn jal), Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Nisha amalaki churna, Reference: Vaghbhat Uttarsthan 40/48, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Koshn jal), Additional Information: -
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1 Patients aged between 25 to 70 years with irrespective of gender education religion socioeconomic class
2 Patients presenting with classical features of Madhumeha that is
Pipasavridhhi polydipsia
Prabhut mutrata polyuria
Avila mutrata turbidity
Naktamutrata
3 Patients having sign and symptoms of Madhumeha having diagnosis history of 1 yr and newly diagnosed cases 
 
ExclusionCriteria 
Details  1 Patients with Insulin Dependent Diabetes Mellitus-II with history of disease more than 1 yr
2 Patients aged less than 25 years and more than 70 years
3 Patient presenting with Madhumeha due to the complication of other major systemic disease
4 Pregnant women and lactating mothers will be excluded 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the efficacy of Kantak PanchamoolChurna and Nisha amalaki churn in Madhumeha with special reference to DM 2
2 To compare the efficacy of Kantakpanchamool churna & Nishaamalaki Churn in Madhumeha with special reference to DM II
 
30 days 
 
Secondary Outcome  
Outcome  TimePoints 
1 To review literature of Madhumeha
2 To review literature of DM II
3 To study the untoward effect of Kantak Panchamool Churna if any 
12 months 
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
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)   20/12/2024 
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 Metabolic disorder. Characterised by chronic hyperglycaemia with disturbances of carbohydrate, fat & protein metabolism resulting from defects in insulin secretion, insulin action or both. Long term diabetes can causes consequences like brain damage,heart diseases,nephritic,neurotic disease , retinal diseases, amputation that is micro vascular and macro vascular. Diabetes can be correlated to Madhumeha in Ayurveda. Symtopms of Madhumeha like prabhut mutrata ,avil mutrata, pipasaaadhikya can be correlated with polyurea ,urine turbidity ,polydipsia in Diabetes Mellitus type 2.The Prevalence of Diabetes in India is 11.8% according to the National Diabetes and Diabetic Retinopathy Survey report released by the health and family welfare ministry. With increasing incidence of Diabetes Mellitus-II due to changed lifestyle & habits disease has been became as major health issues in society. Disease Progress with many complications leading to cause major illness hampering daily activities of patients. As well as drugs used for treatment also cause many complications. So there is need to aware about disease severity, side effects of modern medicine and modifications in lifestyle. There is need for effective, safe, potent, drug which controls hyperglycemia any adverse reaction and limit the signs symptoms related to Diabetes Mellitustype2. Hence, in the present study will be done on the effects of Kantak panchamula churna on lowering blood sugar level as drug is stated by Sushruta in 38 th chapter of Sushrut sutrasthana.

 
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