| CTRI Number |
CTRI/2024/07/069794 [Registered on: 01/07/2024] Trial Registered Prospectively |
| Last Modified On: |
29/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Therapeutic] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Medicated decoction in the management of Iron Deficiency Anemia |
|
Scientific Title of Study
|
A Randomized controlled clinical study to evaluate the effect of Punarnavashtaka kwatha over Punarnava mandura in the Management of Panduroga with Special reference to Iron Deficiency Anemia |
| 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 Kalpana Metri |
| Designation |
PG Scholar |
| Affiliation |
DGM Ayurvedic medical college and hospital |
| Address |
Department of kayachikitsa Room No 3 Shri DGM Ayurvedic Medical College and Hospital Post Graduate and Phd studies center Gadag
Gadag
KARNATAKA
582103
India |
| Phone |
8296340429 |
| Fax |
|
| Email |
kalpanapmetri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R V Shettar |
| Designation |
Professor |
| Affiliation |
Shri DGM Ayurvedic medical college and hospital |
| Address |
kayachikitsa OPD Room No 3 Shri DGM Ayurvedic Medical College and Hospital Post Graduate and Phd studies center Gadag
Gadag
KARNATAKA
582103
India |
| Phone |
9845613116 |
| Fax |
|
| Email |
shettar_dr@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kalpana Metri |
| Designation |
PG Scholar |
| Affiliation |
DGM Ayurvedic medical college and hospital |
| Address |
Department of kayachikitsa Room No 3 Shri DGM Ayurvedic Medical College and Hospital Post Graduate and Phd studies center Gadag
Gadag
KARNATAKA
582103
India |
| Phone |
8296340429 |
| Fax |
|
| Email |
kalpanapmetri@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri DGM Ayurvedic medical college and Hospital Gadag Karnataka India 582103 |
|
|
Primary Sponsor
|
| Name |
Dr.Kalpana Metri |
| Address |
Shri DGM Ayurvedic Medical College and Hospital Post Graduate and Phd studies center Gadag Karnataka India Pincode 582103 |
| 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 Kalpana Metri |
Shri DGM Ayurvedic medical college and hospital |
OPD no.3
Department of Kayachikitsa
Shri DGM Ayurvedic Medical College and Hospital, Gadag
Gadag
KARNATAKA |
8296340429
kalpanapmetri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DGM Ayurvedic Medical college and Hospital PG and PhD center Ethical clearence committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:D508||Other iron deficiency anemias. Ayurveda Condition: PANDUROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Punarnava mandura, Reference: Charaka Chikitsa sthana 16 , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Freshly prepared Takra), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Punarnavashtaka Kwata, Reference: Yogaratnakara Purvardha Pandurogaadhikara 6, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 15(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Sukhoshna jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects having clinical features of pandu roga like panduta shrama bhrama arohanaayasa dourbalya aruchi pidkodwestana shoonakshikoota shotha gatrashoola
Subjects of pandu roga between the age group of 18 to 60 years irrespective of either sex
Hb% between 6gm/dl to 11gm/dl |
|
| ExclusionCriteria |
| Details |
Anemia associated with any malignancy
Known case of sickle cell anemia pernicious anemia thalassemia
Subjects with uncontrolled DM HTN
Subjects under chemotherapy and radiation treatment
Subjects with TB HIV and other systemic disorders
Pregnant women and Lactating mothers will be excluded |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To know the increased level in the Heamoglobin
To know the reduction level in the classical signs and symptoms of pandu roga like paleness in skin nails sclera tongue sole weakness after doing hardwork confusion exertion while climbing stairs weakness aruchi dislikes the food generalized body ache |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not mentioned |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
11/07/2024 |
| 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="2"
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
|
Panduroga is pitta pradhana tridoshaja vyadhi according to Acharya Charaka it is one among the rasavaha srotodushti which is responsible for the less production of poshaka from the rasadhatu as a result depletion of rakta takes place aggravated pitta expelled from hrudaya by vata dosha it circulates all over the body it reaches the space between twak and mamsa thus brings abnormality in kapha vata rakta twak mamsa leading to abnormal complexion like panduta in twak nakha netra jihwa hasta pada tala and other lakshanas like shrama bhrama arohanaayasa dourbalya aruchi shoonakshikootashotha gatrashoola with the direct reference Yogaratnakara in pandurogadhikara Punarnavashtaka kwatha is indicated in panduroga.it is effective in sarvangashotha udararoga panduroga sthoulya lalasrava and urdvagakapha roga punarnavashtaka kwatha has actions like anti inflammatory diuretic antioxidant hepatoprotective renal protective mild laxative these properties which may help in the management of pandu roga. |