| CTRI Number |
CTRI/2024/09/073355 [Registered on: 04/09/2024] Trial Registered Prospectively |
| Last Modified On: |
27/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
STUDY TO EVALUATE THE
EFFICACY OF MURVADYA CHURNA IN PANDU |
|
Scientific Title of Study
|
͘RANDOMISED OPEN CONTROLLED CLINICAL TRIAL TO EVALUATE THE
EFFICACY OF MURVADYA CHURNA IN PANDU |
| 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 Pradnya Bhaskar Mali |
| Designation |
PG scholar |
| Affiliation |
Yashwant Ayurvedic college post graduate training and research center kodoli |
| Address |
Yashwant Ayurvedic College Post Graduate Training and Research
Centre Kodoli Tal Panhala Dist
Kolhapur
Kaychikitsa Department
Second floor Opd no 17
Yashwant Ayurvedic College Post Graduate Training and Research
Centre Kodoli Tal Panhala Dist
Kolhapur
Kaychikitsa Department
Second floor Opd no 17
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
7387036854 |
| Fax |
|
| Email |
malipradnya933@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dipali Swami |
| Designation |
Associate Professor kayachikitsa department |
| Affiliation |
Yashwant Ayurvedic college post graduate training and research center kodoli |
| Address |
Yashwant Ayurvedic College Post Graduate Training and Research
Centre Kodoli Tal Panhala Dist
Kolhapur
Kaychikitsa Department
Second floor Opd no 17
Yashwant Ayurvedic College Post Graduate Training and Research
Centre Kodoli Tal Panhala Dist
Kolhapur
Kaychikitsa Department
Second floor Opd no 17
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9960003947 |
| Fax |
|
| Email |
drdipaliswamis@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradnya Bhaskar Mali |
| Designation |
PG scholar |
| Affiliation |
Yashwant Ayurvedic college post graduate training and research center kodoli |
| Address |
Yashwant Ayurvedic College Post Graduate Training and Research
Centre Kodoli Tal Panhala Dist
Kolhapur
Kaychikitsa Department
Second floor Opd no 17
Yashwant Ayurvedic College Post Graduate Training and Research
Centre Kodoli Tal Panhala Dist
Kolhapur
Kaychikitsa Department
Second floor Opd no 17
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
7387036854 |
| Fax |
|
| Email |
malipradnya933@gmail.com |
|
|
Source of Monetary or Material Support
|
| S G Phytopharma Address B-53D /21 , MIDC Gokul shirgaon, S G phytopharma Pharmaceuticals ltd Kolhapur 416237 |
|
|
Primary Sponsor
|
| Name |
Dr Pradnya Bhaskar Mali |
| Address |
OPD No 17 Kayachikitsa Department Second floor
Yashwant Ayurvedic College Post Graduate Training and Research
Centre Kodoli Tal Panhala Dist Kolhapur MAHARASHTRA 416114 India |
| 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 Pradnya Mali |
Yashwant Ayurvedic college Post Graduate Training and Research center Kodoli |
Yashwant Ayurvedic College Post Graduate Training and Research
Centre Kodoli
OPD No 17 kayachikitsa
Department Second Floor
Yashwant Ayurvedic College Post Graduate Training and Research
Centre Kodoli Tal Panhala Dist
Kolhapur Kolhapur
MAHARASHTRA 416114 India
Kolhapur
MAHARASHTRA |
7387036854
malipradnya933@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Comittee Yashwant Ayurvedic College PGT and RC Kodoli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:D509||Iron deficiency anemia, unspecified. Ayurveda Condition: PANDUROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Murvadya Churn, Reference: Gadnigrah, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -koshna Jal), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient with sign and symptoms of Panduta,Daurbalya,Shwas,Bhrama (Shram Bhramni-pidita),Aruchi (Anorexia), Gauravam (Heaviness of the body),Pindikodveshtan, Shunakshikuta |
|
| ExclusionCriteria |
| Details |
Pregnant women, Lactating mothers.
Anaemia associated with other known history of diseases like Liver
Cirrhosis, Ascites, Congestive Cardiac Failure, Acute Coronary Syndromes, AIDS, Tuberculosis, Malignancy, Helminthic infection , known history of Chronic Blood loss conditions |
|
|
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 |
| To study the effect of Murvadya Churna in Pandu vyadhi |
90days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The improvement in the patients will be assessed on the basis of relief in signs and symptoms of Pandu.
For this assessment the main signs and symptoms will be given in gradation
depending upon their severity and all the parameters of assessment before and after the follow up day will be taken into consideration to assess the effectiveness of the treatment .
To study etiopathology of Pandu in detail according to ayurveda
To improve quality of life & reduce discomfort of patient
To achieve the outcome of study in 90 days |
90days |
|
|
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)
|
07/09/2024 |
| 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="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
|
͘My title is RANDOMISED OPEN CONTROLLED CLINICAL TRIAL TO EVALUATE THE EFFICACY OF MURVADYA CHURNA IN PANDU . Patients those are having Lakshanas of Pandu like Panduta,Rukshata,Daurbalya, Bhrama, Ayasen Shvasa (Arohan),Aruchi, Pindikodveshtan will be included for study.Hb% ranges above 7 gm/dL to 10 gm/dL. Objective parameter is Checking Complete blood count which is Haemoglobin level ,Packed cell volume ,MCH ,MCV,RDW ,ESR level of every patient of group ,follow up on Day 0 and 90th. Treatment given Murvadya churna 2 gm twice a day(vyaane-udane) for 90 days.To study the change in sign and symptoms of pandu vyadhi. |