| CTRI Number |
CTRI/2024/04/065998 [Registered on: 19/04/2024] Trial Registered Prospectively |
| Last Modified On: |
08/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study of Rohitakadi Vati in management of type-2 Diabetes Mellitus. |
|
Scientific Title of Study
|
Clinical evaluation of Rohitakadi Vati in Prameha with special reference to type-2 Diabetes Mellitus – a Randomized placebo-controlled trial. |
| Trial Acronym |
Nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mohit Ashok Pandit |
| Designation |
PhD Student |
| Affiliation |
Shree Saptashrungi Ayurved Mahavidyalay and Hospital |
| Address |
Shree Saptashrungi Ayurved Mahavidyalay and Hosptal, Department - Kayachikitsa, Hospital building, Ground floor, OPD number - 2, Kamal nagar, Hiravadi, Panchavati, Nashik, Maharashtra 420003
Nashik
MAHARASHTRA
420003
India |
| Phone |
9823815199 |
| Fax |
|
| Email |
dr.mohitayu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Somdatta Kulkarni |
| Designation |
Guide. Professor and HOD of Kayachikitsa Department |
| Affiliation |
Shree Saptashrungi Ayurved Mahavidyalay and Hosptal, Nashik |
| Address |
Shree Saptashrungi Ayurved Mahavidyalay and Hosptal, Department Kayachikitsa, Hospital building, ground floor, OPD number 2, Kamal nagar, Hiravadi, Panchavati, Nashik, Maharashtra 420003
Nashik
MAHARASHTRA
420003
India |
| Phone |
9860268117 |
| Fax |
|
| Email |
somdattak85@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohit Pandit |
| Designation |
PhD scholar |
| Affiliation |
Shree Saptashrungi Ayurved Mahavidyalay and Hosptal, Nashik |
| Address |
Shree Saptashrungi Ayurved Mahavidyalay and Hosptal, Department Kayachikitsa, Hospital Building, ground floor, OPD number 2, Kamal nagar, Hiravadi, Panchavati, Nashik, Maharashtra 420003
Nashik
MAHARASHTRA
420003
India |
| Phone |
9823815199 |
| Fax |
|
| Email |
dr.mohitayu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shree Saptashrungi Ayurved and Mahavidyalay, Kamal nagar, hiravadi, Panchavati, Nashik, Maharashtra 420003 |
|
|
Primary Sponsor
|
| Name |
Dr Mohit Pandit |
| Address |
Shree Saptashrungi Ayurved and Mahavidyalay, Kamal nagar hiravadi, Panchavati, Nashik, Maharashtra 420003 |
| 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 Mohit Pandit |
Shree Saptashrungi Ayurved Mahavidyalay and Hospital |
Department Kayachikitsa, Hospital Building, Ground floor, OPD number 2, Kamal nagar hiravadi, Panchavati, Nashik, Maharashtra 420003
Nashik
MAHARASHTRA |
9823815199
dr.mohitayu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Shree Saptashrungi Ayurved Mahavidyalaya, Nashik |
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 | Comparator Arm (Non Ayurveda) | | - | Tablet Placebo | Route - Oral
Dosage form- Tablet
Dose - 1000 mg
Frequency - BD - two times a day
Time - Before food
Duration - 90 days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Rohitakadi Vati, Reference: Astang Hruday Chikitsa sthan 15/91-92, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Confirmed diagnosis of type-2 diabetes mellitus according to American Diabetes Association criteria.
2) Fasting glucose level between 125 to 200 mg/dL, Post prandial blood sugar level 200 to 280 mg/dL.
3) HbA1c level between 6.4 to 7.5 %.
|
|
| ExclusionCriteria |
| Details |
1) Type-1 diabetes mellitus
2) Gestational diabetes
3) Patient with type 2 diabetes mellitus below age 30 years and above age 60 years.
4) Patients with fasting sugar more than 200 mg/dL and post prandial more than 280 mg/dL will be excluded from study.
5) Pregnancy or breastfeeding.
6) History of severe diabetic complications, such as diabetic ketoacidosis.
7) Patients with history of severe liver, kidney or heart disease.
8) Patients having any other life threatening disease.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Fasting Blood Sugar (FBS)
Post Prandial Blood Sugar (PPBS)
Glycosylated Hb (HbA1c)
Urine Sugar
|
90 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Polyuria, Polydipsia, Polyphagia, Tiredness, Hyperhidrosis, Dryness of mouth, Burning sensation in Hands & Feet. |
Every 15 days for 90 days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
03/06/2024 |
| 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="2"
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 single blind, parallel group, randomized placebo controlled trial on Type 2 Diabetes Mellitus patients with special reference to Prameha. Study will be conducted at Shree Saptashrungi Ayurveda Mahavidyalaya and Hospital, Nashik. 200 patients of known cases of Type 2 Diabetes Mellitus, from age group 30 years to 60 years will be selected randomly. Out of 200 patients, 100 patients will be allocated to the trial group and 100 patients will be allocated to the controll group. Trial group will receive Tablet Rohitakadi Vati, 1 g, two times a day, before food,for 90 days and control group will receive placebo for 90 days. Subjective parameters will be assessed every 15 days for 90 days. Objective parameters such as Blood sugar levels, HbA1C, Urine sugar will be assessed at the beginning of trial and after 90 days. Statistical analysis will be done by using appropriate statistical test such as Wilcoxon sign rank test for subjective parameters and paired and unpaired ’t’ test for objective parameters. Conclusion will be drawn based on observation, results and discussion. |