| CTRI Number |
CTRI/2026/02/103985 [Registered on: 16/02/2026] Trial Registered Prospectively |
| Last Modified On: |
16/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study on the effect of Gayatryadi Kashaya in Prediabetes |
|
Scientific Title of Study
|
A Clinical Study to evaluate the therapeutic effect of Gayatryadi Kashaya 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 Tony Thomas Manamel |
| Designation |
Associate Professor |
| Affiliation |
|
| Address |
Department of Kayachikitsa
Sharada Ayurveda Medical College and Hospital, Devinagara, Talapady, Mangaluru
Dakshina Kannada
KARNATAKA
575023
India |
| Phone |
9035804963 |
| Fax |
|
| Email |
tonythomasmanamel@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Murali K |
| Designation |
|
| Affiliation |
|
| Address |
Centre of Textual Studies and Publications, Vaidyaratanam P.S. Variers Arya Vaidya Sala, Kottakkal
Malappuram
KERALA
676503
India |
| Phone |
9447141281 |
| Fax |
|
| Email |
muralivaidyaka@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tony Thomas Manamel |
| Designation |
Associate Professor |
| Affiliation |
|
| Address |
Department of Kayachikitsa
Sharada Ayurveda Medical College and Hospital, Devinagara, Talapady, Mangaluru
Dakshina Kannada
KARNATAKA
575023
India |
| Phone |
9035804963 |
| Fax |
|
| Email |
tonythomasmanamel@gmail.com |
|
|
Source of Monetary or Material Support
|
| Glocal University, Mirzapur, Saharanpur, Uttarpradesh 247121 |
| Sharada Ayurveda Medical College and Hospital, Devinagara, Talapady, Mangaluru, Karnataka 575023 |
|
|
Primary Sponsor
|
| Name |
Dr Tony Thomas Manamel |
| Address |
Sharada Ayurveda Medical College and Hospital, Devinagara, Talapady, Mangaluru, Karnataka 575023 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Tony Thomas Manamel |
Glocal College of Ayurvedic Medical Science and Research Center. |
Department of Kayachikitsa, Mirzapur, Saharanpur, Uttar Pradesh-247121
Saharanpur
UTTAR PRADESH |
9035804963
tonythomasmanamel@gmail.com |
| Dr Tony Thomas Manamel |
Sharada Ayurveda Medical College and Hospital |
Department of Kayachikitsa, Devinagara, Talapady, Mangaluru, Karnataka 575023
Dakshina Kannada
KARNATAKA |
9035804963
tonythomasmanamel@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Glocal University Institutional Ethics Committee |
Approved |
| Sharada Ayurveda Medical College Institutional Ethics Committee |
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: Gayatryadi Kashaya, Reference: Ashtanga Hridaya, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 15(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Honey 5 ml with Water 30 ml), Additional Information: Patients would be given a well-formed, printed chart given to the individuals indicating Pathya and Apathya. | | 2 | Comparator Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:Honey 5ml with Water 30 ml, Pathya/Apathya:yes, Pathya:Yava, Methika, Kharjura, Godhuma, Nimba, Kamala, Shyamaka, Karavellaka, Utpala, Kodrava, Patola, Jangal Mamsa, Bajara, Rasona, Mudga, Udumbar, Purana Sura, Chanaka, Tala Phala, Sarsapa, Tikta Shaka, Ingudi, Goghrita, Apathya:Dugdha, Nava-Anna, Dadhi, Guda, Takra, Urada, Ikshuvikara, Gramya-Audaka Anoopa Mamsa, Pista-Anna, Madhur-Amla- Lavana Rasadi Aahara, Naveen Sura, Kapha-Meda Vardhak Aahara. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients fulfilling the diagnostic criteria.
2. Age group - between 18 years to 55 years.
3. Gender - Male and Female both will be included.
|
|
| ExclusionCriteria |
| Details |
1. Diabetes Mellitus (Type-1&2).
2. Patients of age group less than 18 and more than 55 years.
3. Any associated Systemic disorder that will interfere with present treatment.
4. Patients associated with renal, cardiac, and other complication.
5. Pregnant and lactating women.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fasting Blood Sugar Level, Postprandial Blood Sugar level and Urine Routine. |
At Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Fasting Lipid Profile & HbA1c. |
At Baseline, & 16 weeks |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
10/03/2026 |
| 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="3"
Months="0"
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 is a prospective, randomized, open-label, parallel arm interventional clinical study designed to evaluate the therapeutic effect of Gayatryadi Kashaya in patients with prediabetes.
The study will be conducted in India over a total duration of 4 months, including a 3-month intervention period. A total of 120 patients will be enrolled and randomly allocated into two groups:
- Intervention group – receiving Gayatryadi Kashaya 15 mL twice daily added with 30 ml water, with Anupana of Honey 5ml before food.
- Control group – receiving Honey 5ml BD with 30 ml water before food.
Primary Outcome Measures:
- Fasting Blood Sugar (FBS)
- Postprandial Blood Sugar (PPBS)
- Urine routine examination
These will be assessed on Day 0 (baseline), Day 30, Day 60, Day 90, and Day 120.
Secondary Outcome Measures:
- Fasting lipid profile
- HbA1c
These will be assessed on Day 0 (baseline) and Day 120. |