| CTRI Number |
CTRI/2026/02/104786 [Registered on: 25/02/2026] Trial Registered Prospectively |
| Last Modified On: |
09/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare Vyoshadi Guggulu and Amritadi Guggulu in improving blood sugar levels in people with Prediabetes. |
|
Scientific Title of Study
|
A comparative clinical trial to evaluate the effect of Vyoshadi Guggulu and Amritadi Guggulu in the management of 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 |
Anjaly Peius |
| Designation |
PG Scholar |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda College and Hospital,Chennai,Tamilnadu |
| Address |
PG Department of Kayachikitsa,
Sri Jayendra Saraswathi Ayurveda College and Hospital, Nazarathpet,Chennai.
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
8547055628 |
| Fax |
|
| Email |
anjuzpc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradeep Kumar Moharana |
| Designation |
Professor |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda College and Hospital,Chennai,Tamilnadu. |
| Address |
PG Department of Kayachikitsa,
Sri Jayendra Saraswathi Ayurveda College and Hospital, Nazarathpet,Chennai.
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
9444123608 |
| Fax |
|
| Email |
pkm_ayur@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Anjaly Peius |
| Designation |
PG Scholar |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda College and Hospital,Chennai,Tamilnadu |
| Address |
PG Department of Kayachikitsa,
Sri Jayendra Saraswathi Ayurveda College and Hospital, Nazarathpet,Chennai.
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
8547055628 |
| Fax |
|
| Email |
anjuzpc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Jayendra Saraswathi Ayurveda College and Hospital. |
|
|
Primary Sponsor
|
| Name |
Anjaly Peius |
| Address |
Sri Jayendra Saraswathi Ayurveda College and Hospital. Nazarathpet,Chennai - 600123 |
| 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 |
| Anjaly Peius |
Sri Jayendra Saraswathi Ayurveda College and Hospital. |
Nazarathpet,
Chennai,
Tamilnadu,
600123
Thiruvallur
TAMIL NADU |
8547055628
anjuzpc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Sri Jayendra Saraswathi Ayurveda College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E00-E89||Endocrine, nutritional and metabolic diseases. Ayurveda Condition: PRAMEHA-PURVARUPAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vyoshadi Guggulu, Reference: Ashtangahrudaya Vatavyadhi chikitsa Adhyaya, Route: Oral, Dosage Form: Guggulu , Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 91 Days, anupAna/sahapAna: Yes(details: water), Additional Information: The group will receive Avipattikara churna for kostasodhana at early morning in empty stomach on Day 0 | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Amritadi Guggulu, Reference: Bhavaprakasa Mahyamakhanda Vatarakta Chikitsa Adhyaya, Route: Oral, Dosage Form: Guggulu , Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 91 Days, anupAna/sahapAna: Yes(details: water), Additional Information: The group will receive Avipattikara churna for kostasodhana at early morning in empty stomach on Day 0
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
69.00 Year(s) |
| Gender |
Both |
| Details |
Subjects fulfilling the following diagonostic criteria that is FBS is 100 to 125 mg/dl or HbA1c between 5.7 and 6.4 percent.
sample comes under moderate risk and high risk groups according to IDRS Scale.
Sample who fulfill the criteria and willing to sign written informed consent for participation |
|
| ExclusionCriteria |
| Details |
Known case of diabetes mellitus that is greater than or equal to 126 mg/dl or HbA1C greater than or equal to 6.5 percent.
Current use of Antidiabetic medications and Insulin
Known case of Renal failure,Cardio vascular disease or Cancer.
Pregnant ladies and lactating mothers.
Severe psychiatric illness or cognitive disorders interfering with compliance.
People with alcohol dependency and drug dependency |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To manage the HbA1c levels in Prediabetes. |
Assessment will be done on Day 91 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of both the drugs in the management of HbA1c levels in prediabetes |
91 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
25/03/2026 |
| 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="2"
Months="0"
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
|
In
Asian countries, India has been projected as the country with the fastest
growing population of diabetic patients and in terms of “Diabetes capital of
the world” Diabetes prevalence is increasing rapidly in the present scenario.
Globally an estimated 422 million adults are living with
diabetes, the number is projected to almost double by 2030(American diabetes
association).The Global prevalence of prediabetes is 5.8%
in 2021 will increase upto 6.5% in 2045. Tamil Nadu experienced the
highest incidence rate in 2021 with 392.41 per 100,000 and
prevalence is 8.3%. In India, around 77 million people above the
age of 18 years are suffering from diabetes and nearly 25 million are prediabetics . The prevalence of
prediabetes in India is 22.25% (2025).The growing burden of prediabetes underscores the
importance of effectively implementing diabetes prevention policies and
interventions. Lifestyle modifications alone often lack
sustainability without holistic support. Many patients in the
prediabetic stage are unwilling to start allopathic medication or adhere to
diet and exercise plans, increasing the
urgency for alternative approaches. Hence, Ayurvedic
interventions offer a natural, personalized, and sustainable alternative for
prevention and reversal effective prevention,
especially in low-income countries, is needed to slow the diabetes epidemic. |