| CTRI Number |
CTRI/2023/04/051750 [Registered on: 19/04/2023] Trial Registered Prospectively |
| Last Modified On: |
18/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A comparison between Nimbadi Ghana Vati and Phalatikadi Ghana Vati in Madhumeha (Diabetes mellitus 2). |
|
Scientific Title of Study
|
A COMPARATIVE STUDY TO EVALUATE THE EFFEICACY OF NIMBADI GHANA VATI AND PHALATRIKADI GHANA VATI IN THE MANAGEMENT OF MADHUMEHA (TYPE 2 DIABETES MELLITUS)- A RANDOMISED CONTROLLED CLINICAL TRIAL. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Karishma Rabha |
| Designation |
P G Scholar |
| Affiliation |
All India Institute Of Ayurveda, Gautampuri, Sarita Vihar ,NEW Delhi-110076 |
| Address |
OPD no.7,Ground floor, Hospital Block, All India Institute Of Ayurveda, Gautampuri,Sarita Vihar, NEW Delhi - 110076
South
DELHI
110076
India |
| Phone |
8368521535 |
| Fax |
|
| Email |
karishmarabha57@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Karishma Rabha |
| Designation |
P G Scholar |
| Affiliation |
All India Institute Of Ayurveda, Gautampuri, Sarita Vihar ,NEW Delhi-110076 |
| Address |
OPD no.7,Ground floor, Hospital Block, All India Institute Of Ayurveda, Gautampuri,Sarita Vihar, NEW Delhi - 110076
South
DELHI
110076
India |
| Phone |
8368521535 |
| Fax |
|
| Email |
karishmarabha57@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Raja Ram Mahto |
| Designation |
Assistant professor, Department of kayachikitsa |
| Affiliation |
All India Institute Of Ayurveda, Gautampuri, Sarita Vihar ,NEW Delhi- 110076 |
| Address |
Room no.615,6th floor,Department of kayachikitsa, Academic Block,All India Institute Of Ayurveda, Gautampuri, Sarita Vihar, NEW Delhi-110076
South
DELHI
110076
India |
| Phone |
8877033663 |
| Fax |
|
| Email |
mahtorajaram88@gmail.com |
|
|
Source of Monetary or Material Support
|
| ALL INDIA INSTITUTE OF AYURVEDA,GAUTAMPURI,SARITA VIHAR, NEW DELHI |
|
|
Primary Sponsor
|
| Name |
ALL INDIA INSTITUTE OF AYURVEDA |
| Address |
ALL INDIA INSTITUTE OF AYURVEDA, GAUTAMPURI, SARITA VIHAR,NEW DELHI- 110076 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Karishma Rabha |
All India Institute Of Ayurveda |
Room no.-618,6th floor, Academic block, Department of Kayachikitsa, ALL INDIA INSTITUTE OF AYURVEDA,GAUTAMPURI,NEW DELHI,110076
South
DELHI |
8368521535
karishmarabha57@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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: Nimbadi Ghana Vati , Reference: Sushrut chikitsasthan 11/8, Pramehachikitsitam, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -Nisha Aamlaki Phanta ), Additional Information: -20ml Nisha Aamlaki phanta as Anupana in each dose will be given. | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Phalatrikadi Ghana Vati , Reference: Sushrut chikitsasthan 11/8, Pramehachikitsitam, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Nisha Aamlaki Phanta ), Additional Information: 20ml Nisha Aamlaki phanta will be given with each dose . |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Either gender in the age group 30-60 yrs with classical signs and symptoms of Madhumeha.
2.Patients fulfilling the general diagnostic criteria for diabetes mellitus.(as per diabetic protocol by MOA/AIIA).
3.RBS more than or equal to 200 to 450 mg/dl.
4.FBS more than or equal to 126 to 350 mg/dl.
5.PPBS more than or equal to 200 to 450 mg/dl.
6.Glycosylated haemoglobin more than or equal to
6.5% to 15%.
7.Newly/early diagnosed cases to be included as per following criteria:
- patients accidentally diagnosed in routine check-up or when appeared with other complaints in the hospital.
- early diagnosed diabetic patients (< 3yrs of diabetes) and not taking any pharmacological drugs.
- patients who used to take conventional medicines and stopped taking them for 3 months & were willing to take Ayurvedic Medicines.
|
|
| ExclusionCriteria |
| Details |
1.Patients having insulin dependent DM(type1) and receiving OHA.
2.Age <30yrs and>60yrs, pregnant women and lactating mothers.
3.Excessive blood sugar:FBS>350mg/dl and PPBS>450mg/dl.
4.Emergency conditions in cases of DM, chronic complications and patients with other diseases such as chronic liver diseases, thyroid disorders, hypertension, CKD, heart diseases etc.
5.Patients who were not fit for yoga. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in the level of Glycosylated haemoglobin (HbA1c).
|
(DAY-0)(DAY-7)(DAY-14)(DAY-30)(DAY-45)(DAY-60)(DAY-75)(DAY-90)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Improvement in the signs and symptoms of Madhumeha after 90days.
2.Reduction in the level of FBS & PPBS at 30th,60th and 90th day of the study .
3.Improvement in the quality and quantity of urine after 90 days.
4. Improvement in the quality of life after a period of 90days.
|
(DAY-0)(DAY-7)(DAY-14)(DAY-30)(DAY-45)(DAY-60)(DAY-75)(DAY-90) |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
25/04/2023 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Diabetes mellitus is a complex disorder of multiple etiology resulting in chronic hyperglycemia resulting from the defect in insulin action, insulin secretion, or both .Diabetes mellitus becomes burden to the global and especially in India because of the high prevalance rate which has risen from 7.1% in 2009 to 8.9% in 2019, currently , 25.2 million adults are estimated to have impaired glucose tolerance, which has estimated to increase to 35.7 million in the year 2045.
Various treatment modalities are available in conventional medical science such as use of oral hypoglycemic agents but, prolonged use of OHA and their side effects and uncertainity of safety profile thus, need to establish the newer treatment choices which cause minimal side effects and plant based medicines have that strength to correct the condition of hyperglycemia .Changing lifestyles, job patterns, and dietary habits increase the risk of type 2 diabetes mellitus. |