| CTRI Number |
CTRI/2023/10/058246 [Registered on: 04/10/2023] Trial Registered Prospectively |
| Last Modified On: |
03/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effects of Phalatrikadi kwath and Madhugrit in patients with Type 2 Diabetes Mellitus. |
|
Scientific Title of Study
|
A Comparative clinical study of Phalatrikadi kwath and Madhugrit in Madhumeha (Type 2 Diabetes Mellitus) |
| 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 PARIDHI PAINULY |
| Designation |
Pg scholar |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
Department of Kayachikitsa, OPD no. 13/14,Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar Uttarakhand
India.
Department of Kayachikitsa, OPD no. 13/14,Patanjali Ayurveda Hospital Haridwar Uttarakhand
India.
Hardwar
UTTARANCHAL
249405
India |
| Phone |
8958757958 |
| Fax |
|
| Email |
paridhipainuly123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashwini Nilesh Ingle |
| Designation |
Associate professor |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
Department of Kayachikitsa, OPD no. 13/14,Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar Uttarakhand
India.
Department of Kayachikitsa, OPD no. 13/14,Patanjali Ayurveda Hospital Haridwar Uttarakhand
India.
Hardwar
UTTARANCHAL
249405
India |
| Phone |
919881165320 |
| Fax |
|
| Email |
dr.aningle2014@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashwini Nilesh Ingle |
| Designation |
Associate professor |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
Department of Kayachikitsa, OPD no. 13/14,Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar Uttarakhand
India.
Department of Kayachikitsa, OPD no. 13/14,Patanjali Ayurveda Hospital Haridwar Uttarakhand
India.
Hardwar
UTTARANCHAL
249405
India |
| Phone |
919881165320 |
| Fax |
|
| Email |
dr.aningle2014@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patanjali Bhartiya Aryuvigyan evam Anusadhan Santhan
|
|
|
Primary Sponsor
|
| Name |
Patanjali Bhartiya Aryuvigyan evam Anusadhan Santhan |
| Address |
Patanjali Bhartiya Aryuvigyan evam Anusadhan Santhan, Haridwar-249405
Uttarakhand
India
|
| Type of Sponsor |
Private 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 Paridhi Painuly |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
Department of Kayachikitsa, OPD no. 13/14,
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan ,Haridwar, 249405 Uttarakhand
India
Hardwar
UTTARANCHAL |
8958757958
paridhipainuly123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Patanjali Bhartiya Aryurvigyan Evam Anusandhan Sansthan Haridwar Institutional Ethical 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: Phalatrikadi kwath, Reference: ch.sa.chi.6/56, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: lukewarm water), Additional Information: - | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Madhugrit, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 1100(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: lukewarm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Participants will be selected irrespective of gender and socio-economic status.
2.Patients aged between 30 – 65 years.
3.Participants fulfilling the signs and symptoms of Madhumeha.
a. Prabhutmutrata (Polyuria)
b. Kar-pada daha (Burning sensation in hands and feet)
c. Kantha taalusosha (polydipsia)
d. Availa mutrata (Turbid urine)
e. Angasaad (Fatigue)
f. Mukha Madhuryasyata (Sweet taste of mouth)
g. Daurgandhaya (Foul smell)
h. Blood glucose level
i. Fasting Blood glucose from 126mg/dl to 200 mg/dl
j. Post-Prandial Blood glucose from 200 mg/dl to 300 mg/dl
k. HBA1C > 6%
|
|
| ExclusionCriteria |
| Details |
1. Patients with Type I Diabetes (Juvenile Diabetes)
2. Patients who are taking insulin.
3. Women with Gestational Diabetes.
4. Diabetes Mellitus with Hypertension, other endocrinological diseases and any other systemic disease.
5. Diabetes Mellitus with complications such as Retinopathy, Nephropathy and Diabetic foot
6. Pregnancy and lactating women. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Subjective parameters
1.Prabhoot-mutrata (Polyuria - frequency of urination)
2.Kanth taalu shosh (Polydipsia – the feeling of thirst)
3.Angsaad (Fatigue)
4.Avilmutrata (turbid urine)
5.Mukha – madhuryata (sweet taste of mouth)
6.Daurgandhaya (foul smell)
7.Karpada-daha (burning sensation in hand and feet)
Objective parameters
The objective assessment will be done on the basis of changes in the following
•Fasting Blood glucose
•Post-Prandial Blood glucose
•Lipid Profile
•Urine test for glucose
|
0 days, 30 days, 60 days, 90 days
HbA1c –
Time point - 0 days and 90 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Objective parameters
The objective assessment will be done on the basis of changes in the following
1. Fasting Blood glucose
2. Post-Prandial Blood glucose
3. Lipid Profile
4. Urine test for glucose
|
0 days, 30 days, 60 days, 90 days
HbA1c –
Time point - 0 days & 90 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
14/10/2023 |
| 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="6"
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
|
This study is a Open Label, Double Arm Comparative study, comparing the efficacy of Phalatrikadi kwath 40ml twice daily before meal and Madhugrit each 550mg 2 tablets twice daily after meal for 18 months in 40 patients with madhumeha roga that will be conducted in Opd no. 13/14 in Patanjali Ayurvedic Hospital, Haridwar. |