| CTRI Number |
CTRI/2021/12/038908 [Registered on: 24/12/2021] Trial Registered Prospectively |
| Last Modified On: |
24/11/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic
Screening |
| Study Design |
Other |
|
Public Title of Study
|
Prameha(Diabetes) treatment by Haridradigana Basti and Haridradigana ghana Vati |
|
Scientific Title of Study
|
Comparative evaluation of efficacy of Haridradigana Yoga Basti with Haridradigana ghana Vati and Metformin in the management of Diabetes Mellitus Type II (Prameha) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Varinder Singh |
| Designation |
PG Scholar(Panchakarma) |
| Affiliation |
Mahatma Gandhi Ayurveda College Hospital and Research Centre Salod(H),Wardha |
| Address |
Department of Panchakarma Mahatma Gandhi Ayurveda College Hospital and Research Centre Salod(H),Wardha
Maharashtra
Department of Panchakarma Mahatma Gandhi Ayurveda College Hospital and Research Centre Salod(H),Wardha
Maharashtra
Wardha
MAHARASHTRA
442001
India |
| Phone |
8054532704 |
| Fax |
|
| Email |
vrehaan100@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Punam Sawarkar |
| Designation |
Associate Professor |
| Affiliation |
Mahatma Gandhi Ayurveda College Hospital and Research Centre Salod(H),Wardha |
| Address |
Department of Panchakarma Mahatma Gandhi Ayurveda College Hospital and Research Centre Salod(H),Wardha
Maharashtra
Department of Panchakarma Mahatma Gandhi Ayurveda College Hospital and Research Centre Salod(H),Wardha
Maharashtra
Wardha
MAHARASHTRA
442001
India |
| Phone |
9860667023 |
| Fax |
|
| Email |
drsuple.punam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Punam Sawarkar |
| Designation |
Associate Professor |
| Affiliation |
Mahatma Gandhi Ayurveda College Hospital and Research Centre Salod(H),Wardha |
| Address |
Department of Panchakarma Mahatma Gandhi Ayurveda College Hospital and Research Centre Salod(H),Wardha
Maharashtra
Department of Panchakarma Mahatma Gandhi Ayurveda College Hospital and Research Centre Salod(H),Wardha
Maharashtra
Wardha
MAHARASHTRA
442001
India |
| Phone |
9860667023 |
| Fax |
|
| Email |
drsuple.punam@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Panchakarma, Mahatma Gandhi Ayurveda College Hospital and Research Centre, Salod(H),Wardha |
|
|
Primary Sponsor
|
| Name |
Dr Varinder Singh |
| Address |
Department of Panchakarma,Mahatma Gandhi Ayurveda College Hospital and Research Centre,Salod(H),Wardha |
| 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 Varinder Singh |
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod(H) Wardha |
Department of Panchakarma OPD no. 40 Wardha, Maharashtra
Wardha
MAHARASHTRA |
8054532704
vrehaan100@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E116||Type 2 diabetes mellitus with other specified complications. Ayurveda Condition: PRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Tab. Metformin | Hypoglycemic agent Tab.Metformin 500mg OD | | 2 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बसà¥à¤¤à¤¿à¤•à¤°à¥à¤®/वसà¥à¤¤à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: A.H.SU.19/21-23, Procedure details: Yoga Basti with Haridradigana followed Haridradigana Ghana Vati Orally)
(1) Medicine Name: Haridradi gana, Reference: A.H.SU.15/35-36, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Duration: 38 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with either sex having age between 20 -60 years
2.Patients recently diagnosed for uncomplicated NIDDM (type 2 diabetes) and having
Fasting blood sugar level ≥126 mg/dl
Post meal blood sugar level ≥140 mg/dl
3.HbA1c ≥ 6.57
4.Old cases of type-2 DM not taking any other anti-hypoglycaemic drugs.
5.Diabetic Patients suffering from Controlled Hypertension (Blood Pressure not more than ≥140 mmHg or an average Diastolic Blood Pressure not more than ≥90 mmHg)
6.Patients willing to give informed consent
7.Patient fit for Basti Karma as per the Ayurvedic classics
|
|
| ExclusionCriteria |
| Details |
1.Patients suffering from IDDM (Insulin dependent diabetes mellitus) & patient with Type -2 Diabetes on insulin therapy
2.Patients suffering from Juvenile Diabetes or Gestational diabetes (ICD – 10 criteria 024)
3.DM with complications e.g. Retinopathy, Nephropathy, neuropathy ,previous history of coma
4.Patients suffering from any current acute illness, uncontrolled hypertension
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in clinical features associated with Diabetes Mellitus Type II(Prameha) |
1/2 month(45 days) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 To assess the efficacy of Haridradigana Yoga Basti with Haridradigana Ghana Vati over objective parameters ie Blood sugar levels (Fasting and Post Prandial) Urine Sugar level HbA1c in Diabetes Mellitus Type II
2 To assess the efficacy of Metformin over objective parameters ie Blood sugar levels (Fasting and Post Prandial) Urine Sugar level HbA1c in Diabetes Mellitus Type II
3 To compare the efficacy of Haridradigana Yoga Basti with Haridradigana Ghana Vati and Metformin over objective parameters ie Blood sugar levels (Fasting and Post Prandial) Urine Sugar level HbA1c in Diabetes Mellitus Type II
|
1/2 month(45 days) |
|
|
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)
|
15/01/2022 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [vrehaan100@gmail.com].
- For how long will this data be available start date provided 26-09-2024 and end date provided 26-09-2029?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Patients will be recruited from inclusion criteria
Objectives will be
1. To
assess the efficacy of Haridradigana
Yoga Basti with Haridradigana Ghana
Vati over objective parameters i.e.
Blood sugar levels (Fasting &
Post Prandial), Urine Sugar level, HbA1c in Diabetes Mellitus Type II 2. To
assess the efficacy of Metformin over
objective parameters i.e. Blood
sugar levels (Fasting & Post
Prandial), Urine Sugar level, HbA1c in Diabetes Mellitus Type II
To compare the efficacy of Haridradigana Yoga Basti with Haridradigana
Ghana Vati and Metformin over objective parameters i.e. Blood sugar levels (Fasting & Post Prandial), Urine
Sugar level, HbA1c in Diabetes Mellitus Type II
|