| CTRI Number |
CTRI/2024/11/076585 [Registered on: 11/11/2024] Trial Registered Prospectively |
| Last Modified On: |
05/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study to see the effect of two ayurvedic drugs naimly katamkateryadi kwath and phalatrikadi kwath in the 60 patients of prameha (Diabetes) |
|
Scientific Title of Study
|
An open randomized comparative clinical study of katamkateryadi kwath and phalatrikadi kwath in management of prameh with special refernce to hyperglycemia in type 2 diabetes mellitus |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chandrakant Ramchandra Gupta |
| Designation |
post graduate student |
| Affiliation |
APMs Ayurved Mahavidyalaya Sion Mumbai |
| Address |
Department of Kayachikitsa 4th floor APMs Ayurved Mahavidyalaya Near sion railway station Sion East Mumbai
Mumbai MAHARASHTRA 400022 India |
| Phone |
7057081894 |
| Fax |
|
| Email |
guptachandrakant227@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Anaya Pathrikar |
| Designation |
Head Of Department Of Kayachikitsa |
| Affiliation |
APMs Ayurved Mahavidyalaya sion Mumbai |
| Address |
Department Of kayachikitsa APMs sion ayurved mahavidyalaya near sion railway station sion mumbai
Mumbai MAHARASHTRA 400022 India |
| Phone |
9870214595 |
| Fax |
|
| Email |
anayapathrikar@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Anaya Pathrikar |
| Designation |
Head Of Department Of Kayachikitsa |
| Affiliation |
APMs Ayurved Mahavidyalaya sion Mumbai |
| Address |
Department Of kayachikitsa APMs sion ayurved mahavidyalaya near sion railway station sion mumbai
MAHARASHTRA 400022 India |
| Phone |
9870214595 |
| Fax |
|
| Email |
anayapathrikar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayurvidya Prasarak Mandals Seth R V Ayurved Mahavidyalaya Near Sion Station Sion Mumbai 400022 |
|
|
Primary Sponsor
|
| Name |
Chandrakant Ramchandra Gupta |
| Address |
APMs Ayurved Mahavidyalaya Sion near sion railway station sion mumbai 400022 |
| 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 Chandrakant Ramchandra Gupta |
APMs Ayurved Mahavidyalaya and Seth R V Hospital Sion Mumbai |
APMs Ayurved Mahavidyalaya and Seth R V ayurved Hospital Sion
Near sion railway station Mumbai 400022 Mumbai MAHARASHTRA |
07057081894
guptachandrakant227@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| APMs Ayurved Mahavidyalaya Sion IEC |
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: katamkateryadi kwath, Reference: chakradatta pramehadhikar shlok no.18, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: koshna jal), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: phalatrikadi kwath, Reference: chakradatta pramehadhikar shlok no.17, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: koshna jal), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients in the age group of 20 years to 70 years.
2.Sex – Male and Female.
3.Subject who are willing to give written informed consent.
4.BSL - Fasting - 110 mg/dl to 180 mg/dl
Post prandial - 140 mg/dl to 280 mg/dl |
|
| ExclusionCriteria |
| Details |
1.Patients on insulin therapy.
2.Patient having H/O Diabetic ketoacidosis.
3.Patients with Nephropathy and who are on Immunosuppressant medication.
4.Pregnant women and lactating mother. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Blood Sugar Level Fasting and post prandial |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Prabhut Mutrata
2.Avil Mutrata
3.Pipasa Adhikya
4.Ati kshudha
5.Ati nidra
6.Alasya
7.Kara-pada daha
8.Kara-pada suptata
9.Klama |
60 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 4 |
|
Date of First Enrollment (India)
|
16/11/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
16/11/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="6" 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
|
Treatment of Diabetes Mellitus mainly includes the use of Oral Hypoglycaemic Agents (OHAs) and different types of insulin. Patients have to take these medicines lifelong as per their need. OHAs possess their own side-effects like sudden hypoglycaemia, G.I.upsets etc. Their major limitation is primary & secondary failure where patient doesn’t respond to medicines. It compels the physician to increase the dose, change the medicine or switch over to insulin. The major concern about these Oral Hypoglycemic Agent is that they are single targetted acting on specific targets involved in pathology of Diabetes Mellitus, but when we see patients of Diabetes Mellitus in clinical practice most of time they have many etiological factors involved in pathology of Diabetes Mellitus hence multi targeted approaches with less adverse reactions also becomes nessecity in treatement of Diabetes Mellitus. A single herb mentioned in ayurved contain multiple ingredient, multitargeted approaches with less adverse reactions fulfilling the above criteria… There are various formulations in Ayurvedic texts to treat Prameha. It is necessary to study and evaluate efficacy of medications by scientific research. Therefore, I have selected KATAMKATERYADI KWATH to evaluate its clinical efficacy with standard drug that is PHALATRIKADI KWATH. Here I would be checking patient thoroughly to identify causes of the disease so as to execute NIDAN PARIVARJAN and shall treat patients with KATAMKATERYADI KWATH or PHALATRIKADI KWATH as per randomization. I shall follow these patients to note the changes in them with respect to meda dhatvagni deepan, meda prasadan, prameha lakshanani and mutra (medo mala) parikshan and blood sugar level study. Evaluation of results will be done at the end of the trial . |