| CTRI Number |
CTRI/2024/10/075592 [Registered on: 21/10/2024] Trial Registered Prospectively |
| Last Modified On: |
21/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Efficacy of Vrikkamaya ghan vati with arka punarnava in Mutraghata (CKD) |
|
Scientific Title of Study
|
A clinical study to evaluate the efficacy of combined effect of Vrikkamaya Ghan Vati (kalpita yoga) with Arka Punarnava in the management of Mutraghata w.s.r.to Chronic Kidney Disease |
| 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 BRAHMANAND SHARMA |
| Designation |
Associate Professor , Kayachikitsa |
| Affiliation |
University college of Ayurveda, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur |
| Address |
Room no. 111,PG Department of Kayachikitsa ,PGIA, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Karwad, Jodhpur
Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Karwad,Jodhpur -Nagaur highway Road,Jodhpur, 342037
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9460318138 |
| Fax |
|
| Email |
bkmudgal9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr BRAHMANAND SHARMA |
| Designation |
Associate Professor , Kayachikitsa |
| Affiliation |
University college of Ayurveda, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur |
| Address |
Room no. 111,PG Department of Kayachikitsa ,PGIA, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Karwad, Jodhpur
Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Karwad,Jodhpur -Nagaur highway Road,Jodhpur, 342037
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9460318138 |
| Fax |
|
| Email |
bkmudgal9@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr BRAHMANAND SHARMA |
| Designation |
Associate Professor , Kayachikitsa |
| Affiliation |
University college of Ayurveda, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur |
| Address |
Room no. 111,PG Department of Kayachikitsa ,PGIA, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Karwad, Jodhpur
Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Karwad,Jodhpur -Nagaur highway Road,Jodhpur, 342037
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9460318138 |
| Fax |
|
| Email |
bkmudgal9@gmail.com |
|
|
Source of Monetary or Material Support
|
| Postgraduate Institute of Ayurved, Dr.S.R.Rajasthan Ayurved University,Johpur, (Rajasthan), India , 342037 |
|
|
Primary Sponsor
|
| Name |
Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur |
| Address |
Postgraduate institute of Ayurved, Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University, Nagaur road, Karwad, Jodhpur , (Rajasthan), India, Pin code 342037 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Neetu Sharma |
Sanjeevani Ayurved Hospital |
Room no. 114, Postgraduate Department of Kayachikitsa, Postgraduate institute of Ayurved, Dr. S.R.Rajasthan Ayurved University, Jodhpur
Jodhpur
RAJASTHAN |
7615050724
drneetu90@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC PGIA DSRRAU JODHPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N00-N99||Diseases of the genitourinary system. Ayurveda Condition: MUTRAGHATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Vrikkamaya Ghan Vati , Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 1(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -), Additional Information: All ingredients of this drug are mentioned in different classical text books in reference of Mutraghata | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Arka Punarnava, Reference: Prof. Priyavat Sharma, Dravyagun vigyan, part 2, Chaukhambha Bharati Academy, 2022, Page.n. 630, Route: Oral, Dosage Form: Arka, Dose: 20(ml), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients will be taken with symptoms of any kind of Mutraghata are present
2. Glomerular filtration rate level - more than 30ml/min.
3. Blood urea less than 150 mg/dl
4. Serum creatinine level less than 5 mg/dl |
|
| ExclusionCriteria |
| Details |
1. Glomerular filtration rate level - less than 30ml/min.
2. Blood urea more than 150 mg/dl
3. Serum creatinine level more than 5 mg/dl
4. Patients on dialysis treatment and other serious illness cardiovascular disease, Acute mental disorders, Acute organic diseases etc. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in sign and symptoms of Mutraghata |
At baseline 4 weeks 8 weeks & 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To asses the changes in all subjective and objective parameters of the study |
3 months |
|
|
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 |
|
Date of First Enrollment (India)
|
05/11/2024 |
| 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="1"
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
|
It is a Randomized, Prospective, Open label, Interventional single arm clinical trial. Total 60 patients will be selected as per inclusion and exclusion criteria for the study. All the participants will receive Vrikkamaya Ghan Vati (Kalpita or Hypothetical coumpound) and Arka Punarnava . Dosage of Vrikkamaya Ghan Vati will be 1gm TDS and Arka Punarnava will be 20ml TDS. Total duration of the intervention will be 3 months and follow up will be 2 months after the completion of treatment |