| CTRI Number |
CTRI/2025/03/083328 [Registered on: 25/03/2025] Trial Registered Prospectively |
| Last Modified On: |
23/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use of phalatrikadi kwatha bhavit Haritaki churna in Diabetes patients |
|
Scientific Title of Study
|
A CLINICAL STUDY OF
STHOOLA PRAMEHI (DIABETES MELLITUS – TYPE – II)
WITH TRIAL DRUG
PHALTRIKADI KWATHA BHAVIT HARITAKI CHURNA |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prachi Darji |
| Designation |
MD Scholar Kayachikitsa |
| Affiliation |
Government Akhandanand Ayurveda College and Hospital,,Ahmedabad Gujarat. |
| Address |
OPD NO 4, Kayachikitsa Department,Government Akhandanand Ayurveda College, Bhadra,Ahmedabad Gujarat.
Ahmadabad
GUJARAT
380001
India |
| Phone |
6355448209 |
| Fax |
|
| Email |
prachidarji98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dipti Purani |
| Designation |
Assistant professor, Department OF Kayachikitsa |
| Affiliation |
Government Akhandanand Ayurveda College and Hospital,,Ahmedabad Gujarat. |
| Address |
OPD NO 4, Kayachikitsa Department,Government Akhandanand Ayurveda College, Bhadra,Ahmedabad Gujarat.
Ahmadabad
GUJARAT
380001
India |
| Phone |
9427794040 |
| Fax |
|
| Email |
diptipandya73@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Prachi Darji |
| Designation |
MD Scholar Kayachikitsa |
| Affiliation |
Government Akhandanand Ayurveda College and Hospital,,Ahmedabad Gujarat. |
| Address |
OPD NO 4, Kayachikitsa Department,Government Akhandanand Ayurveda College, Bhadra,Ahmedabad Gujarat.
Ahmadabad
GUJARAT
380001
India |
| Phone |
6355448209 |
| Fax |
|
| Email |
prachidarji98@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Akhandanand Ayurveda College, Bhadra,Ahmedabad-380001 Gujarat. |
|
|
Primary Sponsor
|
| Name |
Government Akhandanand Ayurveda College BhadraAhmedabad Gujarat |
| Address |
OPD NO 4, Kayachikitsa Department,Government Akhandanand Ayurveda College and hospital, Bhadra,Ahmedabad-380001 Gujarat. |
| Type of Sponsor |
Government 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 |
| Prachi Darji |
Government Akhandanand Ayurveda College ,Ahmedabad Gujarat. |
OPD NO 4, Kayachikitsa Department,Government Akhandanand Ayurveda College, Bhadra,Ahmedabad Gujarat.
Ahmadabad
GUJARAT |
06355448209
prachidarji98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMITTEE |
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 | Other than Classical | | (1) Medicine Name: PHALTRIKADI KWATHA BHAVIT HARITAKI CHURNA, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Classical signs and symptoms of Prameha.
Fasting plasma glucose 126- 200 mg per dl Post Prandial glucose level 200- 300 mg per dl.
Only non-insulin-dependent Type – II Diabetes Mellitus patients will be included.
Both newly diagnosed patients on allopathic treatment will be included in this study. The dose
of Modern Medicine will be adjusted and tapered during the period of trial as per need.
Patients having BMI (Body Mass Index) greter than 25 and lesser than 35 will be taken for the study. |
|
| ExclusionCriteria |
| Details |
Patient age is below 18 years and above 65 years.
Chronic Pancreatitis, Ketoacidosis, and Parkinson’s disease.
Patients with other metabolic and endocrinal disorders.
BMI less than 25 and more than 35 will be excluded.
Fasting plasma glucose level greater than 200 mg per dl & Postprandial glucose level greater than 300 mg per dl will be
excluded
Patients having any other malignancies or any other systemic or serious illness.
Patients with diabetic wounds or ulcers
Patients of Diabetes mellitus Type 1 (Juvenile Diabetes)
Patients having acute & serious complications of Type 2 Diabetes Mellitus
Patients with Coronary artery disease, Peripheral vascular disease & cerebrovascular disease
Patients having a history of any major complications of Diabetes like Nephropathy,
Retinopathy, Diabetic Foot, etc.
Pregnant women
Insulin-dependent patients.
Otherwhere chronicles like STD, Tuberculosis, etc. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in laboratorial parameters as well as signs and symptoms of
Sthoola Pramehi (Type II Diabetes Mellitus) |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
It is expected that the drug will break or eradicate the root cause of the disease
leading to a permanent cure of Diabetes in Sthoola Pramehi by its Rasayana Properties |
30 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 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="8"
Days="15" |
|
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
|
The drugs in the trial formulation have been described by Acharya Charak collectively as Phalatrikadi Kwatha having action by their Katu tikta rasa and Ruksha guna which help in the Upshoshana of Sweda, Mala, Kleda along with Shaman of kapha. Deepan and pachan effect of Katu and Tikta rasa will have action upon Dhatvagnimandhya and will help in normalizing the body Metabolism. These drugs are easily available in market and are affordable too. So this combination is selected. Kasaya Rasa, Ushna and Ruksha Guna are main properties of Haritaki. It acts as Kaphgna,as a cleanser and it also improves digestion. In prameha there is Dusti of Medovaha Srotas and Dhatvagni Mandya. Hence Dravya which is of Ushna and Ruksha Guna with Lekhan and Shoshan properties is required that can cleanse the Medovaha Srotas and to increase Dhatvagni. So, in reference to this concept Haritaki processed in Phalatrikadi Kwatha for seven times is selected that can sharpen the action of Haritaki with its Rasayana property.
Diagnostic Criteria : PrabhootavilaMutrara Pipasadhikya Kshudhadhikya Swedadhikya Nindradhikya Gala Talu shosha Kara Padatala Daha Kara Padarala Supti Angagandha Shrama Tandra The sample size is 30 patients. Phalatrikadi Kwatha Bhavit Haritaki Churna will be given in 3gm dose with Madhu for thrice a day. Study Design is Open labelled Clinical Trial. |