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
|
|
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
|
|
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
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Drug | Classical | | (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 | 2 | Comparator Arm | Drug | Classical | | (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 mutraâ€. 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 hyperglycemia. Depending 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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