| CTRI Number |
CTRI/2025/09/094344 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
05/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Phaltrikadi Ghanvati will be given to patients of Diabetes Mellitus. |
|
Scientific Title of Study
|
Standard Controlled Clinical Evaluation of Phaltrikadi Ghanvati in Madhumeha (NIDDM) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rajni |
| Designation |
Pg Scholar Kayachikitsa Department |
| Affiliation |
Uttarakhand Ayurved University Gurukul Campus Haridwar Uttarakhand |
| Address |
OPD 5 Department of Kayachikitsa Uttarakhand Ayurved University,Gurukul Campus Haridwar
Hardwar
UTTARANCHAL
249404
India |
| Phone |
8126208756 |
| Fax |
|
| Email |
rajni.pauri24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dinesh Kumar Goyal |
| Designation |
Professor |
| Affiliation |
Uttarakhand Ayurved University Gurukul Campus Haridwar |
| Address |
OPD 5 Department of kayachikitsa uttarakhand ayurved university,Gurukul Campus,Haridwar
Hardwar
UTTARANCHAL
249404
India |
| Phone |
9411731180 |
| Fax |
|
| Email |
dineshdr157@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rajni |
| Designation |
PG Scholar |
| Affiliation |
Uttarakhand ayurved university gurukul campus haridwar |
| Address |
OPD 5 Department of kayachikitsa uttarakhand ayurved university,Gurukul Campus Haridwar
Hardwar
UTTARANCHAL
249404
India |
| Phone |
8126208756 |
| Fax |
|
| Email |
rajni.pauri24@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of P.G.kaychikitsa,uttarakhand ayurved university,gurukul campus,Haridwar 249404 India |
|
|
Primary Sponsor
|
| Name |
Rajni |
| Address |
OPD 5 Department of kayachiktsa,uttarakhand ayurved university,gurukul campus haridwar uttarakhand 249404,India |
| Type of Sponsor |
Other [SELF ] |
|
|
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 Rajni |
Uttarakhand ayurved university Gurukul campus Haridwar |
OPD 5 Department of kayachikitsa uttarakhand ayurved university gurukul campus Haridwar
Hardwar
UTTARANCHAL |
08126208756
rajni.pauri24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE UTTARAKHAND AYURVED UNIVERSITY GURUKUL CAMPUS HARIDWAR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E118||Type 2 diabetes mellitus with unspecified complications. Ayurveda Condition: DIA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: BGR-34, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Phaltrikadi Ghanvati, Reference: charak chikitsa 6/40, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient willing to sign the consent form.
2.Fasting blood glucose level more than or equal to 126mg per dl to less than or equal to 200mg per dl
3.Post prandial blood sugar level more than or equal to 200mg per dl to less than or equal to 300 mg per dl
4.HbA1c more than or equal to 6.5 percentage to less than or equal to 9 percentage. |
|
| ExclusionCriteria |
| Details |
1.Patients of type 1 Diabetes Mellitus.
2.Patients having past history of MI,unstable angina or stroke.
3.Patients suffering from AIDS,cancer,tuberculosis,psychiatric illness.
4.pregnant and lactating women. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
relief in subjective parameters.
1. Prabhutmutrata(polyuria)
2.Trishnadhikya(polydipsia)
3.Kshudhadhikya(polyphagia)
4.Daurbalya(weakness)
5.Kara-pada-taladaha(burning sensation of both palms and feet)
6.Avilmutrata(turbidity in urine) |
4-6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
relief in objective parameters.
1.Blood sugar fasting
2.Blood sugar post prandial
3.HbA1c |
Assessment will be done on 0th day,30 day,60 day & 90 day for FBS & PPBS.And Hba1c will be done on 0th day & 90day. |
|
|
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 |
|
Date of First Enrollment (India)
|
01/10/2025 |
| 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
|
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 STANDARD CONTROLLED CLINICAL EVALUATION OF PHALTRIKADI GHANVATI IN MADHUMEHA (NIDDM) FOR AGE GROUP BETWEEN 20 TO 70 YEARS FOR A DURATION OF 90 DAYS. THE STUDY WILL BE CONDUCTED AT UAU GURUKUL CAMPUS HARIDWAR ON 40 PATIENTS. IN THIS STUDY 20 PATIENTS WILL BE ADMINISTERED PHALTRIKADI GHANVATI AND 20 PATIENTS WILL BE ADMINISTERED BGR-34 FOR 90 DAYS. THE ASSESSMENT WILL BE DONE ON THE BASIS OF SUBJECTIVE AND OBJECTIVE PARAMETERS. THE STUDY WILL BE CONDUCTE AT OPD/IPD LEVEL OF PG DEPARTMENT OF KAYACHIKITSA. THE ASSESSMENT WILL BE DONE AT THE INTERVAL OF 30 DAYS OF THE CLINICAL TRIAL AND THE RESULTS OBTAINED WILL BE TABULATED AND STATISTICALLY ANALYZED USING APPROPRIATE TESTS. |