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CTRI Number  CTRI/2024/11/076677 [Registered on: 12/11/2024] Trial Registered Prospectively
Last Modified On: 11/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Randomised Controlled Study of Kampilladi churna in Diabetes Mellitus Type II (Madhumeha)  
Scientific Title of Study   A Randomised Controlled Trial To Evaluate The Efficacy Of Kampilladi Churna In The Management Of Madhumeha W.S.R. To Diabetes Mellitus Type II.  
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 Bhumika Rajai 
Designation  PG Scholar 
Affiliation  Bhausaheb Mulak Ayurveda Mahavidyalaya and Reseach Hospital,Nandanwan,Nagpur  
Address  Department of Kayachikitsa, Bhausaheb Mulak Ayurveda Mahavidyalaya and Reseach Hospital,Great Nag Road Nandanwan Nagpur,440009 Maharashtra India

Nagpur
MAHARASHTRA
440009
India 
Phone  8669069273  
Fax    
Email  bhumikar111@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Chhaya Tanmane 
Designation  H.O.D And Proff of Kayachikitsa Department 
Affiliation  Bhausaheb Mulak Ayurveda Mahavidyalaya and Reseach Hospital,Nandanwan,Nagpur 
Address  Department of Kayachikitsa Bhausaheb Mulak Ayurveda Mahavidyalaya and Reseach Hospital Great Nag Road Nandanwan Nagpur 440009 Maharashtra India

Nagpur
MAHARASHTRA
440009
India 
Phone  9422174598  
Fax    
Email  ctanmane@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Bhumika Rajai 
Designation  PG Scholar 
Affiliation  Bhausaheb Mulak Ayurveda Mahavidyalaya and Reseach Hospital,Nandanwan,Nagpur 
Address  Department of Kayachikitsa, Bhausaheb Mulak Ayurveda Mahavidyalaya and Reseach Hospital,Great Nag Road Nandanwan Nagpur,440009 Maharashtra India

Nagpur
MAHARASHTRA
440009
India 
Phone  8669069273  
Fax    
Email  bhumikar111@gmail.com  
 
Source of Monetary or Material Support  
Bhausaheb Mulak Ayurveda Mahavidhalaya and Research Hospital Great Nag Road Nandanwan Nagpur 440009 Maharashtra India 
 
Primary Sponsor  
Name  Dr Bhumika Rajai 
Address  Opd No-8 Kayachikitsa Department Bhausaheb Mulak Ayurveda Mahavidyalaya and Reseach Hospital,Great Nag Road Nandanwan Nagpur 440009 
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 Bhumika Rajai  Bhausaheb Mulak Ayurveda Mahavidyalaya and Reseach Hospital,Nagpur,Kayachikitsa opd  OPD 8 Department of Kayachikitsa Bhausaheb Mulak Ayurveda Mahavidyalaya and Reseach Hospital,Great Nag Road Nandanwan Nagpur,440009 Maharashtra India
Nagpur
MAHARASHTRA 
08669069273
-
bhumikar111@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC BMAM  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: Vallipanchamool churna, Reference: Sushrut samhita., Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Ushnodaka), Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: Kampilladi Churna , Reference: chakradutta, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Ushnodaka), Additional Information:
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1)Subject with age between 30 to 70 years of both sexes.
2) Newly diagnosed patients of Type II Diabetes Mellitus fulfilling criteria of
diagnosis having 50% and more than 50% of cardinal signs and symptoms of
Madhumeha.
3) Subject with fasting blood sugar between 126-200 mg/dl.
4) Subject with post meal blood sugar between 200-250 mg/dI.
5) Subject with HbA1c between 6.5- 8%.
6)Patients with Controlled Hypertension with medications (on drugs), fulfilling
above criteria of diagnosis of Type II Diabetes Mellitus (Madhumeha)
7)Subject who is willing ready to participate in the research project 
 
ExclusionCriteria 
Details  1) Subject with complications of Diabetes Mellitus (Type II).
2) Pregnant and lactating women.
3) Subjects with multiple endocrine disorders, malignancy or other systemic illness
affecting blood sugar level.
4) Participate in other clinical trial. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.To evaluate the clinical efficacy of Kampilladi churna in the management of
Madhumeha w.s.r. to Diabetes mellitus type II.
Blood sugar will be assessed by Objective criteria will be assessed by glucometer i.e
FBS AND PBS every 15 days and
HbA1C will be assessed on 0th day and 90th day
2. To study the etiopathology of Madhumeha w.s.r. to Diabetes mellitus type II. 
Follow up of Fbs and Pbs is at 0th,15th,30th
,45th,60th ,75th ,90th day
Hba1c at 0th day and 90 th day
Final assessment on 90th day
 
 
Secondary Outcome  
Outcome  TimePoints 
1.Subjevtive criteria of madhumeha will be assessed by scoring pattern developed by Guddoye and Vyas–
1) Mukhamadhurya(sweetness in mouth)
2) Karpadasupti(numbness in palm and foot)
3) Dantadinammaladhikya(infection)[43]
4) Nidradhikya(excess sleep)
5) Pipasavriddhi(polydipsia)
6) Mutradhikya(polyuria)[43]
7) Swedadhikya(excess perspiration)
8) Karpadadaha(burning sensation in palm and foot)
9) Alasya(general debility)
10) Kshudhadhikya (increase in appetite)
11) Daurbalata (weakness)
2. To study the literature of Diabetes mellitus type II from modern point of view and from different ayurvedic Samhitas 
90 days
Follow up at every 15 days 0th,15th,30th,45th,60th ,75th ,90th day
Final assessment on 90th day
 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   22/11/2024 
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="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   Ayurvedic remedies for Madhumeha(Diabetes mellitus) are the oldest among all the available therapies, which includes in the prameha category. Pramehas are a list of urinary disorders, especially characterized by profuse urination with several abnormal qualities due to doshik imbalancesP rameha has been mentioned that it is a group of disorders in which there is an increased frequency of micturition, the volume of urine is also increased, and the urine becomes turbid. Acharyas have explained that in Madhumeha there is vitiation of Vata Kapha Pradhana Tridosha associated with Meda and other Dhatus along with Ojas as Dushya which comes out of the body through Mutravaha Srotas.
          A similar disease has been described in modern medical sciences as Diabetes Mellitus type 2 .Ramchandran A (2012)Diabetes Mellitus (DM) refers to a group of metabolic disorders characterized by chronic hyperglycaemia, polyuria, polydipsia, polyphagia, emaciation, and weakness due to disturbance in carbohydrate, fat and protein metabolism associated with a relative or absolute deficiency in insulin secretion, insulin action or both
            Diabetes mellitus is defined as a disturbance of intermediary metabolism manifesting as chronic sustained hyperglycemia primarily due to either an absolute or relative lack of insulin. W.H.O Consultation (2014)has classified Diabetes mellitus in Four types .Although the prevalences of Type 2 Diabetes mellitus is increasing worldwide than Type 1, Prevalence rate of Diabetes Mellitus In India is 11.3% with (95% type II DM)
 Rationale of Study
       Rationale of study 
        Now a days due to sedentary lifestyle, junk food consumption and lack of exercise, all this factor hampers metabolism and as a result people are suffering from Diabetes and young generation are at risk of getting Diabetes.The most important thing is ,oral hypoglycemic agents have side effects like sudden hypoglycemia, gastro intestinal tract upset etc Moreover these drugs corrects only hyperglycemia and not the basic pathology ,these drugs prevent further progress of disease and in spite ,patients lands into life threatening complications and therefore there is need of safe and natural remedy. 
         Kampilladi churna is taken up for the present study because no study was carried out in the management of Madhumeha, drugs required for the preparation of churna are easily available, socio economic and method for preparation of churna is very easy. It does not contain any preservatives, can be easily taken by patient.
Study methodology
Type of study – Randomized Controlled Trial. 
Location of study - OPD  department of Kayachikitsa. 
Duration of Study - 18 months after approval of synopsis.
 Duration of treatment –90 days. Last assessment – on 90 th day 

Study setting
Total no of pts-70
Group A – Kampilladi Churna with 35 number of patients. (trial group) BD (before meal) 5GM twice a day with ushnodaka as anupan 
Group B –Vallipanchamool Churna with 35 number of patients. ( control group)BD ( before meal ) 5GM twice a day with ushnodaka as anupan  
Follow up after every 15 days [0th, 15th, 30th, 45th,60th ,75th ,90th day] Final assessment of patient on 90 th day. 
Patients suffering from lakshanas of Madhumeha in the age group of 30 years to 70 years, as they visit OPD  of Kayachikitsa department will be studied randomly irrespective of sex, religion, educational and economic status. Pathya(Ahara and Vihar regimen) -Proper diabetic diet pathya (ahara and vihara regimen)will be advised to the patients. 
Subjective Parameters -1) Mukhamadhurya(sweetness in mouth)     2) Karpadasupti(numbness in palm and foot)    3) Dantadinammaladhikya(infection)     ] 4) Nidradhikya(excess sleep)     5) Pipasavriddhi(polydipsia) 
 6) Mutradhikya(polyuria)[      7) Swedadhikya(excess perspiration)      8) Karpadadaha(burning sensation in palm and foot)    9) Alasya(general debility)    10) Kshudhadhikya (increase in appetite)    11) Daurbalata (weakness)
Ojective parameters
1)RBS and PBS Every 15 th days 
Day 1 -0th day -1st asssessment
1 st Follow up - will be on 15 thday.
2 nd Follow up – will be on 30 th day. 
3 rd Follow up - will be on 45th day. 
4 th follow up- will be on 60th day. 
5 th follow up- will be on 75th day.
 6th last  follow up- will be on 90th day. 
2)HbA1C At 0th day and 90th day
 Identification of drug - It will be done in Dravyaguna department of study Centre. 
Standardization - Standardization will be made from Rasashastra department of Study after preparation of drug before the clinical trials will be conducted.
The drugs will be prepared as stated by Kampilladi Churna as per chakradutta and Vallipanchamool churna as per reference of Sushrutsamhita.
PATHYA ( Ahara and Vihara regimen)  Ahara- [] Patients should follow the following ahara: Moong, Chana, Gehu, Satu, Nachni, Karela, old grains. 
Others-Dhani, laja/murmura ,maricha ,saindhava ,hingu ,haridra ,adraka
 Vihar-  Upto 45 minutes of aerobic exercise per day will be advised to the patients . 
 1) Vyayama -Which includes brisk walking ,jogging, bicycling, swimming 
 2)Kreeda(games).playing badminton and tennis. 
 3)Yoga
Vallipanchmoola Churna         Guduchi-1part  
                                                Vidari -1part 
                                                Sariva -1part 
                                                Rajani -1part 
                                                Ajashringi-1part  
                                          
Kampilladi Churna           Kampillaka-1part  
                                         Kutaj- 1part - 
                                         kapittha-1part 
                                         saptaparna-1part  
                                         shal-1part  
                                         Rohitak -1part 
                                         Bibhitak-1part 
                                  
Conclusion will be drawn on overall assessment, tabulation, statistical analysis and graphic presentation of data
After applying statistical test to data results will be generated 
And Results will be published .

 
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