| CTRI Number |
CTRI/2025/04/084855 [Registered on: 15/04/2025] Trial Registered Prospectively |
| Last Modified On: |
26/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of the Vidangadi yoga in the management of prediabetes. |
|
Scientific Title of Study
|
Double Blind, Randomised, Placebo-Controlled Evaluation of Effect of Vidangadi Yoga in Prediabetes. |
| 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 Prarthana Patel |
| Designation |
PG SCHOLAR |
| Affiliation |
Parul Institute of Ayuved |
| Address |
OPD no 116 Department of Kayachikitsa Parul Ayurved Hospital Parul University AP Limda Tal Waghodiya Vadodara GUJARAT
Vadodara
GUJARAT
391760
India |
| Phone |
08320202514 |
| Fax |
|
| Email |
drprarthanapatel327@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shailesh V Deshpande |
| Designation |
Professor and HOD |
| Affiliation |
Parul Institute of Ayuved |
| Address |
OPD no 116 Department of Kayachikitsa Parul Ayurved Hospital Parul University AP Limda Tal Waghodiya Vadodara GUJARAT
Vadodara
GUJARAT
391760
India |
| Phone |
9763104451 |
| Fax |
|
| Email |
dr.shaileshd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shailesh V Deshpande |
| Designation |
Professor and HOD |
| Affiliation |
Parul Institute of Ayuved |
| Address |
OPD no 116 Department of Kayachikitsa Parul Ayurved Hospital Parul University AP Limda Tal Waghodiya Vadodara GUJARAT
Vadodara
GUJARAT
391760
India |
| Phone |
9763104451 |
| Fax |
|
| Email |
dr.shaileshd@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul institute of Ayurved,Parul University,AP-Limda,TAL-Waghodia,Vadodara,Gujarat,India-391760 |
|
|
Primary Sponsor
|
| Name |
Parul Institute of Ayurved |
| Address |
Faculty of Ayurved, Parul University, AP limda, Tal Waghodia, District Vadodara, Gujarat, India 391760 |
| 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 Prarthana Patel |
Parul Ayurved Hospital |
OPD no 116 Department of Kayachikitsa Parul Ayurved Hospital Parul University AP Limda Tal Waghodiya Vadodara GUJARAT
Vadodara
GUJARAT |
8320202514
drprarthanapatel327@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PARUL INSTITUTE OF AYURVED |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:R730||Abnormal glucose. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vidangadi yoga, Reference: charaka samhita sutra sthana 21, Route: Oral, Dosage Form: Churna/ Powder, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -warm water), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | placebo(Roasted wheat flour) | Roasted wheat flour-oral,Dosage form :capsules,Dose-500 mg BD,Bhaisajya kala-adhobhakta,Duration-3 month,Anupana-warm water |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients fullfilling the criteria of diagnosis according to AMERICAN DIABETES ASSOCIATION(HbA1c range between 5.7 to 6.4 percentage)
2. Patients willing to sign the informed the consent and can participate in the study procedure
|
|
| ExclusionCriteria |
| Details |
1. Known case of diabetes mellitus, insulin dependent diabetes, juvenile diabetes, and gestational diabetes.
2. Known case of major systemic diseases like IHD, malignancy, and uncontrolled hypertension.
3. Patients on prolonged medications(greater than 6 weeks) with corticosteroids or any other drug that may influence the outcome of the study.
4. Pregnant and lactating women.
5. Patients with active infectious diseases like tuberculosis and hepatitis B.
6. Immunocompromised patients. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of Vidangadi Yoga with lifestyle modification and placebo with lifestyle modification in Prediabetes on the basis of HbA1c, FBS, and PP2BS, lipid profile, urine routine and microscopic, fasting serum insulin, and HOMA-IR value. |
At baseline, Day 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the effect of Vidangadi Yoga with lifestyle modification and placebo with
lifestyle modification in Prediabetes on the basis of weight, body composition mass
index (total body fat%, visceral fat level%,skeletal muscle%,resting metabolism, body
age), and symptoms observed in patients. |
BMI -On the baseline, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90.
Body composition mass index -On the baseline, Day 30, Day 60, Day 90 |
To evaluate incidence of Bahudoshavastha and status of Meda Dhatu on the basis of
symptoms of Sthaulya, Meda Vriddhi, Meda Pradoshaja Vikara and Meda Sarata in
cases of prediabetes. |
Baseline, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90 |
|
|
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)
|
15/04/2025 |
| 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
|
· In Modern science, there isn’t a specific medicinal management for Prediabetes. Although lifestyle modification and dietary changes are capable of reversing this condition, it is seldom accepted and followed by patients. If we go through the literature, Prediabetes can also be associated with high blood pressure, low levels of high-density lipoproteins (HDL), and high levels of triglyceride. When these conditions are present along with obesity, they are associated with insulin resistance and can increase the risk of diabetes, heart disease, and stroke. Prediabetes can progress to type 2 diabetes which can further progress to high blood pressure, high cholesterol, heart disease, stroke, kidney disease, and nerve damage. Various studies have been done on type 2 diabetes but there are limited studies conducted on Prediabetes.In Ayurveda, Prameha Purvaroopa are thought to be correlated with Prediabetes, many other conditions can also be compared with Prediabetes. Medovridhhi, Sthaulya, Medo Roga, Bahudosha Avastha are also a condition that we can correlate with Prediabetes. Bahudosha Avastha is a condition where a cluster of symptoms gather in the body including the central and periphery also. Primarily there is a vitiation of Dosha in the body which further vitiates the Dhatus, Strotasa eventually in every disease. but in Prameha, not only Doshas but Dushyas like Rasa, Rakta, Mansa, Majja, Shukra, Oja, Ambu, Vasa, and Lasika also get vitiates. Except Rakta Dhatu all Dushyas are of Kapha Category. Meda and Mansa are important Dushyas and are involved in all types of Prameha. this condition is the precursor of Medovaha Strotodushti.This study focuses assessment of Pre-diabetes through Vidangadi Yoga with lifestyle modification. Vidangadi Yoga is mentioned in the Charaka Samhita Sutrasthana Adhyaya 21 and it is said to be Atisthulyahara by Acharya Chakrapani. Hence, it can be a beneficial medicine in the management of Santarpanjanya conditions. Along with lifestyle modifications, it can be an effective management in prediabetes. This study proposes to assess the effect of Vidangadi Yoga along with lifestyle modifications in comparison with placebo with lifestyle modifications based on FBS, PP2BS, HbA1c Fasting serum insulin, HOMA IR, lipid profile, BMI and IDRS score along with subjective parameters. In the trial group Vidangadi Yoga will be given as per dose of 500 mg twice a day, while in the control group, placebo (roasted wheat flour) in the same dose and filled in similar capsule will be administered.
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