FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/11/076585 [Registered on: 11/11/2024] Trial Registered Prospectively
Last Modified On: 05/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical study to see the effect of two ayurvedic drugs naimly katamkateryadi kwath and phalatrikadi kwath in the 60 patients of prameha (Diabetes) 
Scientific Title of Study   An open randomized comparative clinical study of katamkateryadi kwath and phalatrikadi kwath in management of prameh with special refernce to hyperglycemia 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  Chandrakant Ramchandra Gupta 
Designation  post graduate student 
Affiliation  APMs Ayurved Mahavidyalaya Sion Mumbai 
Address  Department of Kayachikitsa 4th floor APMs Ayurved Mahavidyalaya Near sion railway station Sion East Mumbai

Mumbai
MAHARASHTRA
400022
India 
Phone  7057081894  
Fax    
Email  guptachandrakant227@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anaya Pathrikar 
Designation  Head Of Department Of Kayachikitsa 
Affiliation  APMs Ayurved Mahavidyalaya sion Mumbai 
Address  Department Of kayachikitsa APMs sion ayurved mahavidyalaya near sion railway station sion mumbai

Mumbai
MAHARASHTRA
400022
India 
Phone  9870214595  
Fax    
Email  anayapathrikar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Anaya Pathrikar 
Designation  Head Of Department Of Kayachikitsa 
Affiliation  APMs Ayurved Mahavidyalaya sion Mumbai 
Address  Department Of kayachikitsa APMs sion ayurved mahavidyalaya near sion railway station sion mumbai


MAHARASHTRA
400022
India 
Phone  9870214595  
Fax    
Email  anayapathrikar@gmail.com  
 
Source of Monetary or Material Support  
Ayurvidya Prasarak Mandals Seth R V Ayurved Mahavidyalaya Near Sion Station Sion Mumbai 400022 
 
Primary Sponsor  
Name  Chandrakant Ramchandra Gupta 
Address  APMs Ayurved Mahavidyalaya Sion near sion railway station sion mumbai 400022 
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 Chandrakant Ramchandra Gupta  APMs Ayurved Mahavidyalaya and Seth R V Hospital Sion Mumbai  APMs Ayurved Mahavidyalaya and Seth R V ayurved Hospital Sion Near sion railway station Mumbai 400022
Mumbai
MAHARASHTRA 
07057081894

guptachandrakant227@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
APMs Ayurved Mahavidyalaya Sion IEC  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: katamkateryadi kwath, Reference: chakradatta pramehadhikar shlok no.18, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: koshna jal), Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: phalatrikadi kwath, Reference: chakradatta pramehadhikar shlok no.17, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: koshna jal), Additional Information: -
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Patients in the age group of 20 years to 70 years.
2.Sex – Male and Female.
3.Subject who are willing to give written informed consent.
4.BSL - Fasting - 110 mg/dl to 180 mg/dl
Post prandial - 140 mg/dl to 280 mg/dl 
 
ExclusionCriteria 
Details  1.Patients on insulin therapy.
2.Patient having H/O Diabetic ketoacidosis.
3.Patients with Nephropathy and who are on Immunosuppressant medication.
4.Pregnant women and lactating mother. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Blood Sugar Level Fasting and post prandial  60 days 
 
Secondary Outcome  
Outcome  TimePoints 
1.Prabhut Mutrata
2.Avil Mutrata
3.Pipasa Adhikya
4.Ati kshudha
5.Ati nidra
6.Alasya
7.Kara-pada daha
8.Kara-pada suptata
9.Klama 
60 days 
 
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 4 
Date of First Enrollment (India)   16/11/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  16/11/2024 
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  
   Treatment of Diabetes Mellitus mainly includes the use of Oral Hypoglycaemic Agents (OHAs) 
and different types of insulin. Patients have to take these medicines lifelong as per their need. 
OHAs possess their own side-effects like sudden hypoglycaemia, G.I.upsets etc. Their major 
limitation is primary & secondary failure where patient doesn’t respond to medicines. It 
compels the physician to increase the dose, change the medicine or switch over to insulin. The 
major concern about these Oral Hypoglycemic Agent is that they are single targetted acting on 
specific targets involved in pathology of Diabetes Mellitus, but when we see patients of 
Diabetes Mellitus in clinical practice most of time they have many etiological factors involved in 
pathology of Diabetes Mellitus hence multi targeted approaches with less adverse reactions 
also becomes nessecity in treatement of Diabetes Mellitus. A single herb mentioned in ayurved 
contain multiple ingredient, multitargeted approaches with less adverse reactions fulfilling the 
above criteria…  
 There are various formulations in Ayurvedic texts to treat Prameha. It is necessary to study 
and evaluate efficacy of medications by scientific research. Therefore, I have selected 
KATAMKATERYADI KWATH to evaluate its clinical efficacy with standard drug that is 
PHALATRIKADI KWATH. 
               Here I would be checking patient thoroughly to identify causes of the disease so as to execute 
NIDAN PARIVARJAN and shall treat patients with KATAMKATERYADI KWATH or PHALATRIKADI 
KWATH as per randomization. I shall follow these patients to note the changes in them with 
respect to meda dhatvagni deepan, meda prasadan, prameha lakshanani and mutra (medo 
mala) parikshan and blood sugar level study. Evaluation of results will be done at the end of the 
trial .
 
Close