FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/04/052065 [Registered on: 27/04/2023] Trial Registered Prospectively
Last Modified On: 26/04/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Effect of Madhumehadaman choorna and phaltrikadi kwath in management of Type 2 Diabetes Mellitus. 
Scientific Title of Study   A Randomized Clinical Study To Evaluate The Efficacy Of Madhumehadaman Churna and Phaltrikadi Kwatha In The Management Of Madhumeha W.S.R. Type 2 Diabetes Mellitus  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Indu madaan 
Designation  MD scholar PG department of kayachikitsa 
Affiliation  Ayurvedic and Unani Tibbia college Karolbagh, Delhi 
Address  Room No 6 Adamji Block, Department of kayachikitsa, Ayurvedic and Unani Tibbia college Karolbagh, Delhi.

Central
DELHI
110005
India 
Phone  8958454430  
Fax    
Email  chandanmadaan139@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr SUJATA YADAV 
Designation  Head of Department 
Affiliation  Ayurvedic and Unani Tibbia college Karolbagh, Delhi. 
Address  Room No 6 Adamji Block, Department of kayachikitsa, Ayurvedic and Unani Tibbia college Karolbagh, 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 Karolbagh, Delhi. 
Address  Room No 6 Adamji Block, Department of kayachikitsa, Ayurvedic and Unani Tibbia college Karolbagh, Delhi.

Central
DELHI
110005
India 
Phone  9354925030  
Fax    
Email  sujatakcdelhi@gmail.com  
 
Source of Monetary or Material Support  
Ayurvedic and Unani Tibbia College Hospital karolbagh New Delhi  
 
Primary Sponsor  
Name  Ayurvedic and Unani Tibbia College Hospital. 
Address  Ayurvedic and Unani Tibbia College Hospital 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 Indu madaan  Ayurvedic and Unani Tibbia College Hospital  Room no. 6 Adamji block, pg department of kayachikitsa.
Central
DELHI 
8958454430

chandanmadaan139@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC Ayurvedic and Unani Tibbia College 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: Madhumehadaman choorna , Reference: Rastantrasaar , Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 12 Weeks, anupAna/sahapAna: No, Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Phaltrikadi kwath , Reference: Charak chikitsa , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 12 Weeks, anupAna/sahapAna: No, Additional Information: -
3Comparator ArmDrugClassical(1) Medicine Name: Madhumehadaman choorna , Reference: Rastantrasaar , Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 12 Weeks, anupAna/sahapAna: No, Additional Information: -
(2) Medicine Name: Phaltrikadi kwath , Reference: Charak samhita , 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 20-65 years
2-If yes in any two of four :
Blood sugar fasting- 125 - 150 mg/dl.
PP- 199-250 mg/dl.
Glycosylated Haemoglobin (HbA1c) 6.4% - 7.5%
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-Subject on any other AYUSH medication for glucose control.
2- Patients with type 1 Diabetes Mellitus.
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.
6-Subjects with current or past diagnosis of malignancy (any malignancy diagnosis in
last five years).
7-Subjects who have a recent history or who are currently known to abuse of alcohol
or drugs.
8-Subjects suffering from major systemic illness necessitating long term drug
treatment (Rheumatoid arthritis, Psycho-Neuro-Endocrinal disorders, TB, AIDS etc).
9-Subjects having hypersensitivity to any of the trial drug.
10- Subjects who have completed participation in any other clinical trial during the past
six (06) months.
11- Pregnancy and lactating mothers. 
 
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 
Primary outcome would be measured by- Diabetic specific biomarker - HbA1c levels.  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).
Improvement in subjective parameter.
1. Prabhoota mootrata – Polyurea (excessive urine)
2. Avila mootrata – Unclear / turbid 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. 
 
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 2/ Phase 3 
Date of First Enrollment (India)   01/05/2023 
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:- “
तत्राविलप्रभूतमूत्रलक्षणााःसिव एि प्रमेहााः” ……सु.नि.6/6 
 à¤¸à¤¾à¤®à¤¾à¤¨à¥à¤¯à¤® लक्षणम तेशाम प्रभूतआविलमत्रूता..( अ. ह. नि. १०/७ )
 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. 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.
✓ WHO projects that diabetes will be the 7th leading cause of death in 2030.
✓ 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. 

BRIEF SUMMARY

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 MADHUMEHADAMAN CHURNA & PHALTRIKADI KWATHA. 
1. PHALTRIKADI KWATHA : This indigenous compound drug formulation is described in Charak chikitsa for the treatment of Prameha . The contents of the formulations are as follows;
 à¤«à¤²à¤¤à¥à¤°à¥€à¤•म दारूनिषा विशालाम मुस्ताम च नि:क्िाथ्य निशाम सकलकाम पीबेत कशायम मधुसप्रं युक्तम सिवप्रमेहेशुसमधु तेषु। (Ch. chikitsa 6 )

2. MADHUMEHADAMAN CHURNA: The description of this drug is available in Rastantrasaar for the treatment of madhumeha . The contents of the formulations are as follows;
   1- Gudmaar
   2- Karpaas beej
   3- Jambu beej
   4- Bilwa
   5- Nimbapatra 

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: 
 â€¢ Fasting plasma glucose 7.0 – 8.4 mmol/L (125- 150 mg/dl) 
ʉۢ Two hour plasma glucose 11-13.8 mmol/L (199- 250mg/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
 âž¢ The test should be performed using a glucose load containing the equivalent of 75g anhydrous glucose dissolved in water.

 INVESTIGATIONS: Routine Investigations: Routine investigation will be done before treatment and after treatment.
 âž¢ CBC 
➢ LFT
 âž¢ KFT 
➢ Lipid profile 
➢ Urine-routine and microscopic examination 
Specific investigations: Specific investigation will be done every month.
 âž¢ FBS, PP,
     RBS – will be assessed every 15 days
 âž¢ HbA1c (Glycosylated Haemoglobin) – will be assessed before and after treatment.
Follow up Blood sugar - Every 15th day.
 
Close