| CTRI Number |
CTRI/2024/12/078036 [Registered on: 12/12/2024] Trial Registered Prospectively |
| Last Modified On: |
28/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
effect of dhanvayasa in Diabetes type-2 |
|
Scientific Title of Study
|
Pharmacotherapeutic & Pharmacognostical Study Of Dhanvayasa (Fagonia cretica)in the Management Of Madhumeha (Diabetes Mellitus Type- 2) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr jaya kachchhwaha |
| Designation |
Ph.D scholar and Assistant professor |
| Affiliation |
PGIA,DSRRAU,jodhpur |
| Address |
PG Department of Dravyaguna Vigyan,PGIA,DSRRAU,Nagaur Road,Karwad, Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
8107433499 |
| Fax |
|
| Email |
jaitakachchhwaha36@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajendra prasad purvia |
| Designation |
Associate professor |
| Affiliation |
PGIA,DSRRAU,jodhpur |
| Address |
Room NUMBER 10 PG Department of Dravyaguna Vigyan,PGIA,DSRRAU,Nagaur Road,Karwad,Jodhpur
PG department of Dravyaguna Vigyan ,PGIA,DSSRAU,Nagaur Road,Karwad,Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9782230577 |
| Fax |
|
| Email |
drrajpurvia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jaya Kachchhwaha |
| Designation |
Ph.D scholar and assistant professor |
| Affiliation |
PGIA,DSRRAU,Jodhpur |
| Address |
PG Department of Dravyaguna Vigyan,PGIA,DSRRAU,Nagaur Road,Karwad,Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
8107433499 |
| Fax |
|
| Email |
jaitakachchhwaha36@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr sarvepalli Radhakrishnan Rajasthan Ayurved University,Nagaur Road,Karwad,Jodhpur,Rajastha.
India. Pin code 342037 |
|
|
Primary Sponsor
|
| Name |
Dr.Sarvepalli Radhakrishana Rajasthan Ayurved University Jodhpur |
| Address |
Post Graduate Institute of Ayurved ,Dr.sarvepalli Radhakrishana Rajasthan Ayurved University, Nagaur Road,Karwad,Jodhpur,Rajasthan,India.Pin 342037 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DrRajendra Prasad Purvia |
PGIA,Dr. Sarvepalli Radhakrishnan Rajastahn Ayurved University, Nagaur Road,Karwad,Jodhpur,Rajastahn. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jaya Kachchhwaha |
Sanjeevani Ayurved Hospital |
Sanjeevani Ayurved Hospital,Dravyaguna OPD,Room number 10,DSRRAU Nagaur Road Karwad Jodhpur.
Jodhpur
RAJASTHAN |
8107433499
jaitakachchhwaha36@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC,PGIA,DSRRAU,Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E08-E13||Diabetes mellitus. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Dhanvayasa, Reference: D.N./ Guduchhiyadi varg, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Lukewarm water), Additional Information: NIL |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Diagnosis and confirmed cases of Diabetes Mellitus type 2 on the bases of laboratory investigations.
2.FBS between 126 mg/dl to 200 mg/dl.
3.PPBS between 200 mg/dl to 300 mg/dl.
4.Glycated haemoglobin between 6.5% to 10% . |
|
| ExclusionCriteria |
| Details |
1. Patients having type DM-1
2. Patients of DM-2 who are on the insulin therapy.
3. Diabetes Mellitus -2 With complications.
4. Uncontrolled DM.
5. Drug induced DM.
6. Malignant and accelerated HTN.
7. FBS below 126 mg/dl and above 200 mg/dl.
8. PPBS below 200 mg/dl and above 300 mg/dl.
9. DM with coronary artery disease.
10.Chronic DM.
11.Glycated haemoglobin below 6.5% to above 10%.
12.Pregnant woman and planning to be pregnant within six months. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in labortaory value of FBS,PPBS and Glycated haemoglobin in DM type-2 Patients. |
3 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of Dhanvayasa (Fagonia cretica) on DM Type -2. |
2 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
N/A |
|
Date of First Enrollment (India)
|
12/12/2024 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The number of people with diabetes is steadily rising. The effects of diabetes extend beyond the individual to affects their families and whole societies. Clinical studies on Diabetes Mellitus Type -2 aim understand its causes, evaluate potential treatment, and improve the overall management of the conditions.
it left untreated ,it can be , high glucose levels can damage blood vessels, nerves and organs ,also complications such as eye problems, skin and foot problems,and immune system problems etc.
It is a single arm open labelled interventional study for management of Diabetes Mellitus Type- 2 through herbal preparation of Ghan vati (Dhanvayasa). to evaluate its efficacy .sample size is 100 and trail will be done for 3 months. |