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CTRI Number  CTRI/2024/11/076807 [Registered on: 14/11/2024] Trial Registered Prospectively
Last Modified On: 08/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To study the hypoglycemic effect of kaidarya Patra swarasa in madhumeh with special reference to hyperglycemia in diabetes mellitus type 2 
Scientific Title of Study   Randomised controlled clinical trial to evaluate the hypoglycemic effect of kaidarya patra swrasa in madhumeh with special reference to hyperglycemia in Diabetes mellitus 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  Dr Atul Maroti Pariskar  
Designation  PG Scholar  
Affiliation  Seth Aryangla vaidyak Mahavidyalay satara 
Address  PG department of kayachikitsa Dr M N Aagashe Aryangla Hospital shukrawar peth satara seth chandanmal mutha Aryangla vaidyak Mahavidyalay ITI Road gendamal satara 415002

Satara
MAHARASHTRA
415002
India 
Phone  7057740720  
Fax    
Email  atulpariskar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Atul Maroti Pariskar 
Designation  PG Scholar 
Affiliation  Seth Aryangla vaidyak Mahavidyalay satara 
Address  PG department of kayachikitsa Dr M N Aagashe Aryangla Hospital shukrawar peth satara seth chandanmal mutha Aryangla vaidyak Mahavidyalay ITI Road gendamal satara 415002
PG department of kayachikitsa Seth chandanmal mutha Aryangla vaidyak Mahavidyalaya ITI Road gendamal Satara 415002
Satara
MAHARASHTRA
415002
India 
Phone  7057740720  
Fax    
Email  atulpariskar@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR P D Londhe  
Designation  Professor and HOD kayachikitsa Department  
Affiliation  Seth chandanmal mutha Aryangla vaidyak Mahavidyalay satara  
Address  PG department of kayachikitsa Dr M N Aagashe Aryangla Hospital shukrawar peth satara seth chandanmal mutha Aryangla vaidyak Mahavidyalay ITI Road gendamal satara

Satara
MAHARASHTRA
415002
India 
Phone  9422435765  
Fax    
Email  drpdlondhe4@gmail.com  
 
Source of Monetary or Material Support  
Seth Chandanmal Mutha Aryangla Vaidyak Mahavidyalay Satara PIN 415002 , Maharashtra , India  
 
Primary Sponsor  
Name  Dr Atul Maroti Pariskar  
Address  PG department of kayachikitsa Dr M N Aagashe Aryangla Hospital shukrawar peth satara seth chandanmal mutha Aryangla vaidyak Mahavidyalay ITI Road gendamal satara 415002 
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 Atul Maroti Pariskar   Seth chandanmal mutha Aryangla vaidyak Mahavidyalay satara   Room no 4 OPD Block department of kayachikitsa Dr M N Aagashe Aryangla Hospital shukrawar peth satara 415002 Maharashtra
Satara
MAHARASHTRA 		 7057740720

atulpariskar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical committee SCM Aryangla vaidyak Mahavidyalay satara   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: Kaidarya Patra swarasa , Reference: THE AYURVEDIC PHARMACOPOEIA OF INDIA PART VOLUME-VI First Edition GOVERNMENT OF INDIA MINISTRY OF HEALTH & FAMILY WELFARE DEPARTMENT OF AYUSH NEW DELHI 2008(, Route: Oral, Dosage Form: Swaras/ Juice, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -jal), Additional Information: -Latin name - Murraya koenigii (L.) Spreng Family - Rutaceae SYNONYMS – Surabhinimba, Kaitarya, Kaidarya ,kadhi patta.kaidry mahanimbo, ramno ,raman girinimb, maharista ,shuklshal , kphayah Ras - katu , tikta ,kashaya. Guna - shital laghu snighdh
2Comparator Arm (Non Ayurveda)-Metformin Metformin is an Anti diabetic medicine belong to Buignoid group it works by lowering the glucose production in the liver and delaying the absorption of glucose from the intestine tab Metformin 500mg BiD orally for 30 days
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients irrespective of gender having age between 21 yrs to 60yrs

Patients having clinical signs and symptoms of madhumeha with special reference to hyperglycemia in DM-2

BSL-fasting up to 150 mg/dl or Post prandial up to 250 mg/dl Or both 
 
ExclusionCriteria 
Details  Pregnant and Lactating mothers.

Patients with serious illness like HIV, Malignancy T.B., Major Liver disorders End stage Renal disease.

Individuals recently undergo major surgery

known case of diabetes mellitus type 1 gestational diabetes mellitus
diabeticketoacidosis
diabetic coma, Neurogenic ulcer peripheral vascular disease.
acute infection any where in the body and gangrene.

patients on insulin therapy and steroid therapy. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess the hypoglycemic effect of kaidarya patra swarasa in madhumeha with
special reference to hyperglycemia in Diabetes mellitus -2 		 15th day , 30th day 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the hypoglycemic effect of kaidarya patra swarasa in madhumeha with special reference to hyperglycemia in Diabetes mellitus -2

To study ayurvedic perspective of madhumeha.

To study the side effects of kaidarya patra swaras if any. 		 30days 
 
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 3 
Date of First Enrollment (India)   30/11/2024 
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="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
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 - All of the individual participant data collected during the trial, after de-identification.

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

  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 - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [atulpariskar@gmail.com].

  6. For how long will this data be available start date provided 20-11-2024 and end date provided 20-11-2029?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   Randomised controlled clinical trial.
This study is conducting for to evaluate the hypoglycemic effect of kaidarya patra swrasa in madhumeh with special reference to hyperglycemia in Diabetes mellitus type 2.
According to ayurveda increase in frequency, quantity and turbidity of urine are the cardinal signs and symptoms of Prameha. (Va.Ni.10/7).
Vitiated Dosha’s disturb the metabolism of Meda and Mansa Dhatu (i.e. disturbed carbohydrate, fat and protein metabolism). Kapha Dosha along with these vitiated Dhatus and vikruta kleda vitiate Basti to manifest 20 types of Prameha.
All 20 types of prameha if not treated can leads to madhumeha.Diabetes mellitus (DM) refers to a group of common metabolic disorders that share the

phenotype of hyperglycemia. Several distinct types of DM are caused by a complex

interaction of genetics and environmental factors. Depending on the etiology of the DM,

factors contributing to hyperglycemia include reduced insulin secretion, decreased glucose

utilization, and increased glucose production. The metabolic dysregulation associated with

DM causes secondary pathophysiologic changes in multiple organ systems that impose a

tremendous burden on the individual with diabetes and on Health care system.

DM is the leading cause of end-stage renal disease non traumatic lower-extremity

amputations, and adult blindness. Persons with diabetes are at increased risk for

cardiovascular disease, which is the main cause of morbidity and mortality in this

population. (Harrison p.o.i.m Page no.3094. 21 st edition)(

Recent figures r have shown that 77. million people currently have H diabetes in India, and this number is projected to rise to a 101.2 million by 2030. (RSSDI text book of Diabetes mellitus. Page no.169.)

According to IDF Atlas 10th Edition 2021. where diabetes prevalence was estimated at

9.6% in 2021and 15%in 2015and 19% in 2019 According to pubmed..

Hyperglycemia in diabetic should be assessed aggressively & treated to avoid many

microvascular & microvascular risk factors of hyperglycemia & it’s complications like

Diabetic Retinopathy, diabetic nephropathy, diabetic nephropathy, cardiovascular disease,

cerobrovescular disease, peripheral vascular disease. (RSSDI text book of Diabetes mellitus.

page no. 169. 3rd edition)

Previous Research work shows that Reduction of hyperglycemia significantly reduces cardiovascular events Diabetic complications & morbidity in individual with DM-2

Null hypothesis.  - Kaidaryapatra swarasa. 20 Ml twice a day for 30 days is not significantly effective in
Madhumeha with special reference to hyperglycemia in Diabetes mellitus 2.
 
Alternate  hypothesis -
Kaidaryapatra swarasa. 20 Ml twice a day For 30 days is significantly effective in
madhumeha with special reference to hyperglycemia in Diabetes mellitus -2.

Formulation - kaidarya patra swaras
Dose- 20 ml twice a daily orally .

Anupana - koshna jal
Sevankala- apan kaal . bid . Before Lunch &before Dinner
Duration - 30days
Follow up- 15 th day, & 30th day

 
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