| CTRI Number |
CTRI/2019/02/017423 [Registered on: 04/02/2019] Trial Registered Prospectively |
| Last Modified On: |
01/02/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect Of Nishamalaki And Chandraprabha Vati In Management Of Diabetic Patients |
|
Scientific Title of Study
|
A Comparitive Study To evaluate the Efficacy of Nishamalaki Churna and Chandraprabha vati in 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 |
Prof Dr N R Singh |
| Designation |
HOD Department of Kayachikitsa CBPACS |
| Affiliation |
Chaudhary Brahm Prakash Ayurveda Charak Sansthan |
| Address |
Kayachikitsa Department Chaudhary Brahm Prakash Ayurveda Charak Sansthan Khera Dabar Najafgarh New Delhi
New Delhi
DELHI
110073
India |
| Phone |
9560659728 |
| Fax |
|
| Email |
naimishraj@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr N R Singh |
| Designation |
HOD Department of Kayachikitsa CBPACS |
| Affiliation |
Chaudhary Brahm Prakash Ayurveda Charak Sansthan |
| Address |
Kayachikitsa DepartmentChaudhary Brahm Prakash Ayurveda Charak Sansthan Khera Dabar Najafgarh New Delhi
New Delhi
DELHI
110073
India |
| Phone |
9560659728 |
| Fax |
|
| Email |
naimishraj@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr N R Singh |
| Designation |
HOD Department of Kayachikitsa CBPACS |
| Affiliation |
Chaudhary Brahm Prakash Ayurveda Charak Sansthan |
| Address |
Kayachikitsa Department Chaudhary Brahm Prakash Ayurveda Charak Sansthan Khera Dabar Najafgarh New Delhi
New Delhi
DELHI
110073
India |
| Phone |
9560659728 |
| Fax |
|
| Email |
naimishraj@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Chaudhary Brham Prakash Ayurved Charak Sansthan New Delhi |
|
|
Primary Sponsor
|
| Name |
Chaudhary Brahm Prakash Ayurveda Charak Sansthan |
| Address |
Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar New Delhi |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Prof Dr NR Singh |
Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar New Delhi |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Garima kashyap |
Choudhary Brahm Prakash Ayurved Charak Sansthan New Delhi 110073 |
Kayachikitsa Department Chaudhary Brahm Prakash Ayurved Charak Sansthan khera Dabar Najafgarh Delhi
New Delhi
DELHI |
8800831402
garimakashyap1810@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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Chandraprabha Vati |
Chandraprabha vati18– 500 mg twice in a day for 21 days with water. |
| Intervention |
Nishamalaki churna |
HARIDRA(Nisha)Haridra consists of the dried and cured rhizomes of Curcuma Longa Linn.(Family-Zingiberaceae),a perinneal herb extensively cultivated in all the parts of the country.
DOSAGE:1-3 gm of the drug in the powder form8.
AMALAKI(Fr.Frt.Pulp):Amalaki consists of fresh fruit pulp of EmblicaOfficinalisGaertn.(Family Euphorbiaceae);a small or medium sized tree,found in mixed deciduous forests.DOSAGE:10-20gm of the drug9.The use of Amla juice mixed with Haridra Churna.
All types Prameha including Madhumeha has been mentioned In the list of therapeutic uses of Nishamlaki.
6gm twice in a day for 21 days with lukewarm water |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients fulfilling the diagnostic criteria for Diabetes Mellitus framed by the AMERICAN DIABETES ASSOCIATION
FBS 126 to 200mg/dl
PPBS 200 to 350mg/dl
HbA1c 6.5 to 10%
Patients taking any type of Oral anti diabetic treatment |
|
| ExclusionCriteria |
| Details |
Patients below the age of 40 years and more than the age of 60 years
Fasting Blood Sugar Level <126 mg/dl and >200 mg/dl
Post Prandial Blood Sugar Level <200 mg/dl and >350 mg/dl
HbA1c <6.5%.
Patients depending on the insulin for blood glucose control.
Patients with diabetic complications.
Patients suffering from Secondary Diabetes.
Gestational diabetes.
Pregnant ladies 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 |
FBS
PPBS |
DAY0 day1 day7 day14 day21 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| HbA1c |
day0 day1 day7 day14 day21 |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
10/02/2019 |
| 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
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This trial is conducting for the purpose of MD dissertation award.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. Diabetes itself is not a fatal disease but it is hazardous to health due to its complications. Describing the Prameha, it has been mentioned that it is a group of disorders in which there is 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 asDushya which comes out of the body through Mutravahasrotas. Diabetes prevalence is increasing rapidly previous 2013 estimates from the International Diabetes Federation put the number at 381 million people having Diabetes. The number is projected to be almost double by 2030. in this comparative study to evaluate the efficacy of Nishamalaki Churna and Chandraprabha vati in Madhumeha. STUDY DESIGN- Single centered, open label, randomized control study, efficacy study,with one of active control without any crossover. STUDY AREA OPD & IPD of Ch. Brahm Prakash Ayurveda CharakSansthan,KheraDabar, New Delhi. STUDY POPULATION:Diagnosed patients of Type-2 Diabetes Mellitus will be selected for this purpose on the basis of inclusion criteria.INCLUSION CRITERIA Patients with age between 40-60yrs Sex:Both male and female Patients fulfilling the diagnostic criteria for Diabetes Mellitus framed by the AMERICAN DIABETES ASSOCIATION. FBS-126-200mg/dl PPBS-200-350mg/dl HbA1c-6.5-10% Patients taking any type of oral anti-diabetic treatment. EXCLUSION CRITERIA:Patients below the age of 40 years and more than the age of 60 years Fasting Blood Sugar Level <126 mg/dl and >200 mg/dl Post Prandial Blood Sugar Level <200 mg/dl and >350 mg/dl HbA1c <6.5%. Patients depending on the insulin for blood glucose control. Patients with diabetic complications. Patients suffering from Secondary Diabetes.Gestational diabetes. Pregnant ladies and lactating mothers.GROUP A(TRIAL GROUP) NishamlakiChurna - 6gm twice in a day for 21 days with lukewarm water. GROUP B(COMPARATOR GROUP) Chandraprabha vati18– 500 mg twice in a day for 21 days with water. assessment criteria is symptoms of Madhumeha and FBS PPBS and assess on day0 day1, day7 and day14, day 21 primary outcome is FBS AND PPBS and secondary outcome is HbA1c. |