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CTRI Number  CTRI/2022/04/041754 [Registered on: 08/04/2022] Trial Registered Prospectively
Last Modified On: 04/04/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To see the effect of two medicines namely Kutajadi kwatha and kadaradi kwatha in the disease diabetes 
Scientific Title of Study   A Randomized Comparative Clinical Study To Evaluate The Efficacy Of Kutajadi Kwatha and Kadaradi Kwatha In The management Of Madhumeha W.S.R. To Pre Diabetic And Diabetic State(Type 2) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rahul Singh 
Designation  MD SCHOLAR PG Department of Kayachikitsa 
Affiliation  Ayurvedic and Unani Tibbia College Hospital 
Address  Room No 6 Adamji Block, Department of Kayachikitsa, Ayurvedic and Unani Tibbia College Karol Bagh Delhi

Central
DELHI
110005
India 
Phone  9540180279  
Fax    
Email  rahulsingh95959@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr SUJATA YADAV 
Designation  Head Of Department 
Affiliation  Ayurvedic and Unani Tibbia College Hospital 
Address  Room no 6 Adamji block, Department of Kayachikitsa, Ayurvedic and Unani Tibbia College, Karol Bagh, Delhi

Central
DELHI
110005
India 
Phone  9354925030  
Fax    
Email  sujatakcdelhi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr SUJATA YADAV 
Designation  Head of department 
Affiliation  Ayurvedic and Unani Tibbia College Hospital 
Address  Room No 6 Adamji Block, Department of Kayachikitsa, Ayurvedic and Unani Tibbia College Karol Bagh Delhi

North West
DELHI
110005
India 
Phone  9354925030  
Fax    
Email  sujatakcdelhi@gmail.com  
 
Source of Monetary or Material Support  
Ayurvedic and Unani Tibbia College Hospital 
 
Primary Sponsor  
Name  Ayurvedic and Unani Tibbia College Hospital 
Address  PG Department of KAYACHIKITSA Ayurvedic and Unani Tibbia College Hospital Ajmal Khan road, block 56, Karolbagh, 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 RAHUL SINGH  Ayurvedic and Unani Tibbia College and Hospital   Room no. 6, Adamji block, Department of Kayachikitsa, Ayurvedic and Unani Tibbia College, Karol Bagh, Delhi
Central
DELHI 
9540180279

rahulsingh95959@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:E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: KUTAJADI KWATH, Reference: Chakradutta prameha chikitsa 35/24, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 12 Weeks, anupAna/sahapAna: No, Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: KADARADI KWATH, Reference: Chakradutta prameha chikitsa 35/24, 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  20.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1 Patients  of  either  sex  aged  between  20  to  65  years.

2 If  yes  in  any two  of  the  four:

A  Blood  sugar  –fasting  >  100  and  ≤  125  mg/dl.

B PP > 140 mg/dl and  ≤199  mg/dl.
  Glycosylated  Haemoglobin  (HbA1c)  >  5.7%  and  <  6.4%.

C Subjects  having  classical  symptoms  of  diabetes  with  random glucose  levels  ≥200mg/dl (≤250mg/dl)

3 Subjects  who  are  able  to  come  for  follow  up  on  fixed  visits  and  are  well  aware  about  the treatment  plan.(only  type  2  DM  patients)
4 Subjects  willing  to  participate  and  able  to  provide  written  informed  consent. 
 
ExclusionCriteria 
Details  1 Age below  20  and  above  65yrs.

2 Subject  on    any other  AYUSH  medication  for  glucose  control.

3 Subjects  suffering  from  the  complications  of  Diabetes  mellitus  viz.,  diabetic  neuropathy, diabetic  nephropathy,  diabetic  retinopathy  etc.  which  require  an  urgent  treatment.

4 Uncontrolled  Hypertensive  subjects  (BP  with  or  without  medication  >140/90  mmHg  after  5 mins  of  rest).

5 Subjects  with  any  unstable  Heart  disease  or  known  cases  of  MI,  unstable  angina  or  CHF.   Subjects  with  current  or  past  diagnosis  of  malignancy  (any  malignancy  diagnosis  in  last  five years).

6 Subjects  who  have  a  recent  history  or  who  are  currently  known  to  abuse  of  alcohol  or  drugs.

7 Subjects  suffering  from  major  systemic  illness  necessitating  long  term  drug  treatment (Rheumatoid  arthritis,  Psycho-Neuro-Endocrinal  disorders,  TB,  AIDS etc).

8 Subjects  having  hypersensitivity  to  any  of  the  trial  drug.

9 Subjects  who  have  completed  participation  in  any  other  clinical  trial  during  the past  six  (06) months.  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in subjective parameters
1.  Prabhoota  mootrata  –  Polyurea
2.  Avila  mootrata  –  Unclear  /  turbid  urine (excessive  urine)
3.  Kshudhaadhikya  -Polyphagia(  excessive  hunger)
4.  Pipasaadhikya  -Polydipsia  (excessive  thirst)
5.  Daurbalya/Shram-  Exhaustion  /  tiredness
6.  Suptaangta/Daha  -Polyneuritis  (numbness  /  tingling/  burning  of  soles)
7.  Pindikodveshtana  -  Cramps  while  walking/calf  muscle  pain
8.  Vibandh-  constipation
9.  Swedadikya
10.  Swapna  sukha 
At baseline and after 12 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
Assessment will be done clinically on basis of improvement in objective parameters like
1. Blood sugar fasting (in mg/dl)
2. Blood sugar post prandial(in mg/dl)
3. Glycosylated Haemoglobin (HbA1c in %) 
to be assessed at the beginning and at the end of the trial 
 
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)   15/04/2022 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   INTRODUCTION 
Diabetes Mellitus refers to a group of common metabolic disorders that share the phenotype of hyperglycemia.The major etiological factors of the disease are reduced insulin secretion,decreased glucose utilization,and increased glucose production. Polyuria(frequent urination), polydipsia (increased thirst) and polyphagia (increased hunger)are the main characteristic symptoms of this disease. It is one of the initial diseases described in Egyptian manuscripts. In Ancient Ayurvedic texts this disease is described as Madhumeha, a Vataj sub-type of the disease Prameha, characterized by passing of excessive amount of turbid urine:- 
“तत्राविलप्रभतमत्रलक्षणााःसि एि प्रमहााः” ……सु. नि. 6/61 
The incidence of Diabetes has risen dramatically in the recent times presumably because of reduced activity levels and increasing obesity,and the aging of the population which are also the main etiological factors for this disease. According to latest WHO data an estimated 422 million people suffer from DM globally.2 The global prevalence of diabetes among adults has risen from 4.7% in 1980 to 8.5% in 2014.3 The prevalence of this disease increases with the age, however in the recent times it is seen that it has started effecting the younger age groups and even adolescents are suffering from DM. India actually has the highest number of diabetics of any one country in the entire world and is emerging as diabetic capital of the world. According to International Diabetes Federation, there were 69.1 million cases of diabetes in India in 2015. Hyperglycemia in Diabetes mellitus result either from insulin insufficiency or insulin dysfunction. Type I diabetes (insulin dependent) is caused due to insulin insufficiency because of lack of functional beta cells. Patients suffering from this are therefore totally dependent on exogenous source of insulin while patients suffering from Type II diabetes (insulin independent) are unable to respond to endogenous insulin and can be treated with dietary changes, exercise and medication. Type II diabetes is the more common form of diabetes constituting 90% of the diabetic population. 

NEED OF STUDY: 
 The need of conducting study on this topic could be justified by the following: 
 In 2012, an estimated 1.5 million deaths were directly caused by diabetes and another 2.2 million deaths were attributable to DM.4 
 WHO projects that diabetes will be the 7th leading cause of death in 2030.5 
 Reduction in life expectancy, rising incidence of blindness, end stage renal disease (ESRD), stroke, heart attacks, limb amputations and increase in share of national health services budget are some of the critical issues related to the disease being faced worldwide. 

REVIEW OF LITERATURE: 
AYURVEDIC REVIEW: The disease has been extensively described in ancient Ayurvedic texts of all times including Brihattrayi and Laghuttrayi. Others include Yogratnakar, Vangasen, Chakradatta, Bhaishajya-Ratnavali etc. This disease has been included in Ashtamahagadas by acharya Charaka, Sushruta and Vagbhatta.6 The elaboration of Prameha includes its Nidan, Poorvaroopa, Roopa, Upshaya, Samprapti and Chikitsa. Vitiated tridoshas affects dhatus including Abaddha Meda, Rakta, Shukra, Ambu, Vasa, Lasika, Majja, Rasa, Ojas and Mansa leads to development of the disease and the main site of pathogenesis being the basti or the mootrashya (urinary bladder). Srotas involved are mootravaha and medovaha. The specific symptomatology of twenty types of Prameha’s has been described for diagnostic purpose. The complicated state of the disease in Ayurveda could be read under the heading prameha pidikas. 

MODERN REVIEW
Almost all the text books of western(modern) medicine have mentioned Diabetes and its complications. Etiopathogenesis of the disease along with their symptoms, treatment, prognosis and management is described in detail.Evidences are available in Ayuveda and modern medical sciences which justify the correlation of Madhumeha to Diabetes mellitus. Type-1A Diabetes Mellitus results from autoimmune beta cell destruction while individuals with Type-1B Diabetes Mellitus lack immunological markers indicative of an autoimmune destructive process of beta cell. Type 2 DM is a heterogeneous group of disorders characterised by variable degrees of insulin resistance, impaired insulin secretion, and increased glucose production. 

TRIAL DRUGS REVIEW: 
Indigenous compound formulation used for the trial is KUTAJADI KWATHA & KADARADI KWATHA.

1. KUTAJADI KWATHA : This indigenous compound drug formulation is described in Chakradutt for the treatment of Prameha . 
 The contents of the formulations are as follows;
कुटजासनदार्व्यब्दफलत्रयकृतोSथवा l 
(Chakradatta Prameha Chikitsav35/24 )

2. KADARADI KWATHA:
The description of this drug is available in Chakradutt for the treatment of Prameha . 
The contents of the formulations are as follows; 
कदरखददरपूगक्वाथं क्षौद्राह्वये दपबेत l 
(Chakradatta Prameha Chikitsa 35/18)

DIAGNOSTIC CRITERIA: 
 Diagnosis will be made on the basis of symptoms given in ancient texts and modern literature. Laboratory investigations and clinical findings shall be considered for making diagnosis. WHO criteria for diagnosis of pre diabetics condition are as follows: 
ï‚· Fasting plasma glucose 5.6-6.9 mmol/L (100-125 mg/dl) 
ï‚· Two hour plasma glucose 7.8-11 mmol/L (140-199mg/dl) during an oral glucose tolerance test.
Note: 1. Random is defined as without regard to time since the last meal. 
 Fasting is defined as no caloric intake for at least 8 hrs. 
 The test should be performed using a glucose load containing the equivalent of 75g anhydrous glucose dissolved in water. 
INVESTIGATIONS: 
Routine Investigations: 
 CBC 
 LFT 
 KFT 
 Lipid profile 
 Urine-routine and microscopic examination 
Specific investigations: 
 FBS, PP
 RBS 
 HbA1c (Glycosylated Haemoglobin)
 
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