| CTRI Number |
CTRI/2024/04/065878 [Registered on: 18/04/2024] Trial Registered Prospectively |
| Last Modified On: |
22/02/2024 |
| 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
|
Efficacy of Haritaki Churna in Prediabetes |
|
Scientific Title of Study
|
Efficacy of Haritaki churna in Prediabetes-A Double-Blind Randomized Controlled Clinical Trial |
| 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 Patil Shraddha Anilrao |
| Designation |
PG Scholar Department Of Rasayana Evum Vajikarana |
| Affiliation |
KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya And Research Centre Belagavi |
| Address |
KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya And Research Centre Shahapur Belagavi karnataka 590003
Belgaum
KARNATAKA
590003
India |
| Phone |
8600060490 |
| Fax |
|
| Email |
patilshraddha1798@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suhaskumar Shetty |
| Designation |
Professor Department of Kayachikitsa |
| Affiliation |
KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya And Research Centre Belagavi |
| Address |
KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya And Research Centre Shahapur Belagavi karnataka 590003
Belgaum
KARNATAKA
590003
India |
| Phone |
9449603234 |
| Fax |
|
| Email |
drsuhasshetty@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suhaskumar Shetty |
| Designation |
Professor Department of Kayachikitsa |
| Affiliation |
KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya And Research Centre Belagavi |
| Address |
KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya And Research Centre Shahapur Belagavi karnataka 590003
Belgaum
KARNATAKA
590003
India |
| Phone |
9449603234 |
| Fax |
|
| Email |
drsuhasshetty@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHERS SHRI BMK AYURVEDA MAHAVIDYALAYA AND RESEARCH CENTRE Shahapur
Belagavi Karnataka |
|
|
Primary Sponsor
|
| Name |
Dr Patil Shraddha Anilrao |
| Address |
KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya And Research Centre Shahapur Belagavi Karnataka 590003 |
| 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 Patil Shraddha Anilrao |
KAHERS Shri B.M.Kankanwadi Ayurveda Mahavidyalaya college And Research centre Shahapur Belagavi |
OPD NO 6,7,3,21 Department of Kayachikitsa
Belgaum
KARNATAKA |
8600060490
patilshraddha1798@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Research on Human Subjects KAHERs Shri B M Kankanwadi Ayurveda Mahavidyala and KLE Ayurveda Hospital Shahapur Belagavi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:R730||Abnormal glucose. Ayurveda Condition: PRAMEHA-PURVARUPAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Haridra, Reference: Sastry JLN, illustrated dravyaguna vijnyana 2nd edition, 2nd vol. haridra,Varanasi,chaukhambha orientalia. 2005.p.513-518, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1.5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -warm water), Additional Information: -churna will be filled in capsules of 500mg, 3 capsules wiill be adviced to subject twice a day with warm water | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Haritaki, Reference: Sastry JLN, illustrated dravyaguna vijnyana 2nd edition, 2nd vol. haritaki,Varanasi,chaukhambha orientalia. 2005.p.205-208, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1.5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: - warm water), Additional Information: -churna will be filled in capsules of 500mg, 3 capsules wiill be adviced to subject twice a day with warm water |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Individuals of HbA1c level between 5.7 to 6.4% |
|
| ExclusionCriteria |
| Details |
1.Prediabetes with other systemic conditions like thyroid dysfunction, uncontrolled hypertension with or without medication (more than or equal to 140/90 mmHg).
2.Pregnant and lactating women.
3.Individuals on medication for longer period like glucocorticosteroids, thyroid hormones, pentamidine, nicotinic acid, antipsychotics, thiazides, β-adrenergic agonists.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| changes in Levels of HbA1c, FBS PPBS |
subjective parameters will be assessed on
baseline on 0th 30th 60th 90th, day of the intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in QOL |
subjective parameters will be assessed on
baseline on 0th 30th 60th 90th, day of the intervention. |
|
|
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 3 |
|
Date of First Enrollment (India)
|
01/07/2024 |
| 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="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
|
A randomized,double blind control clinical , parallel group, single center triall comparing efficacy of capsule Haritaki churna 1.5gms twice a day with warm water and capsule haridra churna 1.5gms twice a day with warm water daily for 90 days in 40 patients with Prediabetes will be conducted in KAHERS SHRI BMK AYURVEDA MAHAVIDYALAYA AND RESEARCH CENTRE Shahapur Belagavi Karnataka. The primary outcome will be haritaki churna may help in level of HbA1c, FBS and PPBS of prediabetic subjects and help in improving the QOL. |