| CTRI Number |
CTRI/2023/06/053817 [Registered on: 13/06/2023] Trial Registered Prospectively |
| Last Modified On: |
19/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparision study of two poly herbal formulation in type 2 diabetes mellitus (prameha) |
|
Scientific Title of Study
|
A Comparitive Clinical Evaluation Of TriphalÄdi Kaá¹£Äya & MustÄdi Kaá¹£Äya On Kapha-Pittaja Prameha With Special Reference To Diabetes Mellitus-II In The Purview Of ‘ Saṇtarpanottheá¹£u Gadeá¹£u YogÄ â€¦â€¦â€¦â€¦..Prameheá¹£vapi Te PrayojyÄḥ’ |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abhinesh |
| Designation |
PG Scholar |
| Affiliation |
National Institute Of Ayurveda Deemed To Be University,Jaipur |
| Address |
Room no.103,Ayurveda Samhita And Maulik Siddhanta Depatment,National Institute Of Ayurveda,Jorawar Singh Gate,Amber Road Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
8432688966 |
| Fax |
|
| Email |
kumawatabhinesh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nisha Gupta |
| Designation |
Professor |
| Affiliation |
National Institute Of Ayurveda Deemed To Be University,Jaipur |
| Address |
Room no.103,Ayurveda Samhita And Maulik Siddhanta Depatment,National Institute Of Ayurveda,Jorawar Singh Gate,Amber Road Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9982082832 |
| Fax |
|
| Email |
guptadr.nisha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhinesh |
| Designation |
PG Scholar |
| Affiliation |
National Institute Of Ayurveda Deemed To Be University,Jaipur |
| Address |
Room no.103,Ayurveda Samhita And Maulik Siddhanta Depatment,National Institute Of Ayurveda,Jorawar Singh Gate,Amber Road Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
8432688966 |
| Fax |
|
| Email |
kumawatabhinesh@gmail.com |
|
|
Source of Monetary or Material Support
|
| NATIONAL INSTITUTE OF AYURVEDA DEEMED TO BE UNIVERSITY,JORAWAR SINGH GATE,AMBER ROAD JAIPUR |
|
|
Primary Sponsor
|
| Name |
NATIONAL INSTITUTE OF AYURVEDA,DEEMED TO BE UNIVERSITY |
| Address |
NATIONAL INSTITUTE OF AYURVEDA,JORAWAR SINGH GATE,AMBER ROAD JAIPUR |
| 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 |
| DrAbhinesh |
National Institute of Ayurveda Hospital,jorawar singh gate,Jaipur |
department of maulik siddhanata,opd no.07 and opd no.21
Jaipur
RAJASTHAN |
8432688966
kumawatabhinesh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE NATIONAL INSTITUTE OF AYURVEDA |
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: PRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: MUSTÄ€DI KAṢĀYA, Reference: (च.सू .23/10-12), Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: TriphalÄdi Kaá¹£Äya, Reference: (च.सू .23/10-12), Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: -not any |
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
INCLUSION CRITERIA:–
1. Patients willing to sign Consent Form for the clinical trial.
2. Patients between the age group of 18-70 years, irrespective of sex, caste, religion and socioeconomic status.
3. Patients who fulfill the diagnostic criteria of Pitta-kaphaja Prameha explained in Āyurvedika classics and Diagnostic criteria of Diabetes Mellitus Type-II ICMR guidelines 2018 -
Symptoms of diabetes plus casual or random plasma glucose ≥ 200 mg/dl (Casual means without regard to time of last meal).
ï‚·PPBS >180mg/dl with upper range of 300 mg/dl.
Fasting plasma glucose ≥ 126 mg/dl with upper range of 200 mg/dl.
Glycated Haemoglobin ≥ 6.5% with upper range of 11.5%. |
|
| ExclusionCriteria |
| Details |
EXCLUSION CRITERIA:-
1.Patients below 18 and after 70 years.
2.Cases with deformities that requires surgical treatment.
3.Patients with complications and contraindicated for treatment in Āyurvedika and modern texts.
4.Patients of Diabetes Mellitus Type1
5.Patients on allopathic anti-diabetic drug.
6.Malignancy, other endocrinal disorders, chronic infectious diseases etc.
7.Pregnant and lactating mother.
Patients having any serious illness like cardiovascular diseases, renal diseases etc. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcome:
Improvement in sign and symptoms of the disease and changes in investigation parameters i.e. FBS, PPBS, HbA1c and Urine R/M |
60 DAYS((BEFORE TREATMENT AND AFTER TREATMENT)) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary outcome:
Improvement in quality of life as per Āyurvedika text in terms of Agni, Bala, Nidra, Kostha suddhi etc. and changes in other Lab. Investigation LFT, RFT, CBC,ESR,LIPID PROFILE etc. |
60 DAYS(BEFORE TREATMENT AND AFTER TREATMENT) |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
04/07/2023 |
| 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
|
NONE |
|
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 single centre, open
label, randomized, interventional, and comparing the safety and efficacy of
TriphalÄdi Kaá¹£Äya50 ml & MustÄdi Kaá¹£Äya50ml.
·
Procedure protocol will be followed:
·
Patients who fulfill the diagnostic
criteria of Pitta-kaphaja Prameha explained in Āyurvedika
classics and Diagnostic criteria of Diabetes Mellitus
Type-II
ICMR guidelines will be selected from nia hospital.
·
Patients will be divided in two
groups, each group contains 30 patients, one group will received TriphalÄdi
Kaá¹£Äya (50 ml) and another group will received MustÄdi Kaá¹£Äya (50ml).
·
All
patients will be followed up fortnightly for 60 days.
·
The full details of history &
physical examination of patient will be recorded as per the Performa.
·
Assessment of Subjective Parameters and objective parameters will be done on 15th
day, 30th day, 45th day, 60th day after
initial assessment.
·
The primary outcome measures will be Improvement in sign and symptoms of the disease and
changes in investigation parameters i.e. FBS, PPBS, HbA1c and Urine R/M and
the other Subjective parameters Improvement in quality of life as per Āyurvedika text in terms of Agni, Bala, Nidra, Kostha
suddhi etc. and changes in other
Lab. Investigation LFT, RFT,
CBC,ESR,LIPID PROFILE etc.
·
Results
will be analysed with appropriate statistical tests as follow - Subjective
Parameters – Wilcoxon’s paired rank test and Mann Whitney U test.
·
Objective Parameters – Paired ‘t’ test and
unpaired ‘t’ test.
|