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CTRI Number  CTRI/2022/04/042107 [Registered on: 22/04/2022] Trial Registered Prospectively
Last Modified On: 19/04/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effectiveness of Darvyadi Kwath and Nishamlaki Churna in Diabetes Mellitus 
Scientific Title of Study   A comparative study to evaluate the effectiveness of “Darvyadi Kwatha and Nishamalaki Churna” in management of Madhumeha (Type-2 Diabetes) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Yogesh Kumar Pandey 
Designation  Associate Professor (Dept of Kayachikitsa) 
Affiliation  Chaudhary Brahm Prakash Ayurved Charak Sansthan 
Address  Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar Najafgarh New Delhi South West DELHI 110073 India

South West
DELHI
110073
India 
Phone  9013858523  
Fax    
Email  dryogeshpandey@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sonam Chauhan 
Designation  MD(Ayu) Scholar (Dept of Kayachikitsa) 
Affiliation  Chaudhary Brahm Prakash Ayurved Charak Sansthan 
Address  Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar Najafgarh New Delhi South West DELHI 110073 India

South West
DELHI
110073
India 
Phone  9756998412  
Fax    
Email  negisonam1234@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Yogesh Kumar Pandey 
Designation  Associate Professor (Dept of Kayachikitsa) 
Affiliation  Chaudhary Brahm Prakash Ayurved Charak Sansthan 
Address  Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar Najafgarh New Delhi South West DELHI 110073 India

South West
DELHI
110073
India 
Phone  9013858523  
Fax    
Email  dryogeshpandey@gmail.com  
 
Source of Monetary or Material Support  
Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar New Delhi 
 
Primary Sponsor  
Name  Chaudhary Brahm Prakash Ayurved Charak Sansthan 
Address  Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar Najagfarh New Delhi 
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 Yogesh Kumar Pandey  Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar Najagfarh New Delhi  Department of Kayachikitsa Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar Najafgarh New Delhi South West DELHI
South West
DELHI 
9013858523

dryogeshpandey@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC CBPACS  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: Darvyadi Kwath, Reference: Charak Samhitha Chikitsha Sthana, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 84 Days, anupAna/sahapAna: No, Additional Information: Darvyadi Kwath will be provided in form of powdered raw material for the purpose of making fresh decoction. Decoction thus formed will be given in dose of 50 ml twice daily, empty stomach(minimum four hours of fasting), for a period of 84 days.To ensure uniform preparation, the subjects will be supplied with packets containing crude drug dose for 7 days in one visit. Next packets wi
2Comparator ArmDrugClassical(1) Medicine Name: Nishaamalki, Reference: Charak Samhitha Chikitsha STHANA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 84 Days, anupAna/sahapAna: No, Additional Information: Nishaamalki churna provided in powdered form .craude form of Nisha 3gm and craude form of Amalki 3gm will be mixed to prepare nishaamlaki churna,thus the powdered form will be given 6 gm twice daily after food for the period of 84 days .
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients fulfilling the diagnostic criteria for Diabetes Mellitus framed by the AMERICAN DIABETES ASSOCIATION.
2. FBS-126-250mg/dl
3. PPBS 180-400mg/dl
4. HbA1c 6.4 % and more.
5.Patient is taking anti oral diabetic medicine sulphonylureas dosage (glipizide not more then 20mg, glimipride not more then 8mg, glidazidie not more than 180 mg, pioglitazoe not more than 20 mg
) and bigunoids (metformin not more than 1000 mg)
6. Diagnosed case of Diabetes mellitus at least 6 month back
 
 
ExclusionCriteria 
Details  1. Patients below the age of 21 years and more than the age of 60 years.
2. Fasting Blood Sugar Level >250 mg/dl •
3. Post Prandial Blood Sugar Level >400 mg/dl
4. HbA1c>10%
5. Patients depending on the insulin for blood glucose control.
6. Patients with diabetic complications.
7. Patients suffering from Secondary Diabetes.
8. Gestational diabetes.
9. Pregnant ladies and lactating mothers.
10. Patient is taking any other oral anti diabetic medicine or combination of any oral anti diabetic medicine.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduction in the value of FBS, Glucose in urine and HBA1C  Day1, Day28, Day56, Day84 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in graded symptom of Dhatusamyata andVikaropshama Madhumeha  Day1, Day28, Day56, Day84 
 
Target Sample Size   Total Sample Size="82"
Sample Size from India="82" 
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)   03/05/2022 
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="1"
Months="0"
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  

Madhumeha is a clinical entity described in ayurveda as one of the types of VatajaPrameha. It is also mentioned that Madhumeha urine is sweet, slightly turbid and pale in color just like honey1 and each and every part of the body is sweetened in this disease. Madhumeha is Santarpan ahara viharjanya vyadhi in which Kapha Dosha and Meda Dhatu Dushya is dominant. The cardinal feature of prameha has been mention “avila prabhuta mutra”. Main causes of the disease mainly excessive use of dairy products, sugar products, navdhanya, rice, sea food, excess sleep, lack of exercise. Tridosha responsible for disease as prameha which is characterized by dhushyas such as Med, rakta, vasa, lasika, mansa, rasa, oja, kleda, majja, shukra . Symptoms of prameha includes, excessive thirst, prabhutavilmutra, hast pad taldaha, gurugatrata, swedadhikya, atinidra, kshudhadhikya, daurbalya. In Margavaranjanya Madhumeha the vitiated Kapha and Meda obstructthe passage of Vata. The obstructed Vata is vitiated again and carries Ojas to Basti thus manifests Madhumeha7. In Madhumeha kapha is increase and mix with kleda. Kleda and meda is similer in nature. Excessive kleda mix with kapha goes to vasti and due to gurutva guna do srotoavrodh and manifest disease.

These clinical manifestations are similar to manifestations of a clinical entity named as Diabetes mellitus. Diabetes Mellitus is a group of common metabolic disorders that share the phenotype of hyperglycemiaDepending on the etiology of the Diabetes Mellitus, factors contributing to hyperglycemia include reduced insulin secretion, increased insulin resistance leading to decreased glucose utilization.

For treatment of Madhumeha, it is said that physician should decide upon the therapeutic measures based on disease and strength of dosha.

 

Darvyadi kwath: is herbal formulation for treatment of Madhumeha as mentioned in several proportion.

 Daruharidra is tikta (~bitter) and kashaya (~astringnt) in rasha and virya is ushna (~hot potency) and Prabhava is KaphaghnaDevdaru is tikta (~Bitter) rasha and virya is ushna (~hot potency) and Prabhava is Vatakaphaghna. Nagarmotha tikta (~bitter), katu (~pungent) and kashaya (~astringnt) in rasha and Prabhava is Kaphapittaghna.Amalaki is panch rasha without lavna rasha and virya is ushna (~hot potency) and Rasayana Haritki is panch rasha without lavna rasha and virya is ushna (~hot potency) and Rasayana Vibhitki is Kashaya (~astringnt) rasha and virya is ushna (~hot potency) and Vipaka is Madhura and Prabhava is Tridoshar and Pitta Shamak. Ayurveda has two ways of treatment viz. sodhan (purification) and shamana Chikitsa (pacificatory management). The etio-pathogenesis of Madhumeha, Shamana Chikitsa must be done with such drugs that possess Agni Deepana (digestion and metabolism enhancing) and Kleda nasaka (moistness removing) the aggravated Dosha. Drugs having Tikta (bitter), Kashaya (astringent) and Rooksha (dry) properties are mostly used in the management of Madhumeha. Darvyadi Kwatha possess above mentioned properties required for the management of Madhumeha (Diabetes)1


 
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