| CTRI Number |
CTRI/2025/02/081281 [Registered on: 25/02/2025] Trial Registered Prospectively |
| Last Modified On: |
25/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study to compare the effect of hutabugadi choorna and murvadi choorna in anaemia. |
|
Scientific Title of Study
|
A randomised comparative clinical study on the effect of hutabugadi choorna and murvadi choorna 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 Pallavi S |
| Designation |
2nd year PG scholar kc |
| Affiliation |
ALN Rao Memorial Ayurvedic Medical College Koppa Chikkamagaluru Karnataka India |
| Address |
Department of kayachikitsa 1st floor ALN Rao Memorial Ayurvedic Medical College Koppa
chikmagalur
577126
Karnataka
India
Chikmagalur KARNATAKA 577126 India |
| Phone |
8762033146 |
| Fax |
|
| Email |
pallavishivakumar894@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Triveni V Kalgare |
| Designation |
Professor |
| Affiliation |
ALN Rao Memorial Ayurvedic Medical College Koppa Chikkamagaluru Karnataka India |
| Address |
Department of kayachikitsa 1st floor ALN Rao Memorial Ayurvedic Medical College Koppa
Chikmagalur
577126
India
Chikmagalur KARNATAKA 577126 India |
| Phone |
9449328008 |
| Fax |
|
| Email |
trivenivk3@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Triveni V Kalgare |
| Designation |
Professor |
| Affiliation |
ALN Rao Memorial Ayurvedic Medical College Koppa Chikkamagaluru Karnataka India |
| Address |
Department of kayachikitsa 1st floor ALN Rao Memorial Ayurvedic Medical College Koppa
Chikmagalur
577126
India
Chikmagalur KARNATAKA 577126 India |
| Phone |
9449328008 |
| Fax |
|
| Email |
trivenivk3@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of kayachikitsa 1st floor ALN Rao Memorial Ayurvedic Medical College Koppa Chickmagaluru dist
pin code 577126
karnataka , India . |
|
|
Primary Sponsor
|
| Name |
Dr Pallavi S |
| Address |
Department of kayachikitsa 1st floor ALN Rao Memorial Ayurvedic Medical College Koppa
chikamagaluru
577126
Karnataka
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 Pallavi S |
ALN Rao Memorial Ayurvedic Medical College Hospital |
Kayachikitsa OPD Room no 1, ALN Rao Memorial Ayurvedic Medical College Hospital Koppa
chikamagaluru
577126
Karnataka
India Chikmagalur KARNATAKA |
8762033146
pallavishivakumar894@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ALN Rao Memorial Ayurvedic Medical College |
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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: murvadi choorna, Reference: gada nigraha,pandu roga adyaya, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -ushna jala), Additional Information: -follow up every 15 days. | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: hutabugadi choorna, Reference: sahasrayoga ,choorna prakarana, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -amla takra), Additional Information: -follow up every 15 days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects with the lakshanas of panduta, dourbalya, hataanila, srama, bhrama, and hrutspandana, of pandu.
2.Hb percentage more than 8 gmpercent & less than 13gmpercent in male, less than 12gm percent in females.
3.Subjects above the age of 18 years and below 60 years irrespective of caste, gender, religion and socio-economic status.
4.Subjects must be capable of giving informed consent, willingness and ability to comply with scheduled visits, treatment plans and laboratory tests and other study procedure.
|
|
| ExclusionCriteria |
| Details |
1.Patients with uncontrolled systemic diseases like Diabetes Mellitus and Hypertension.
2.Endocrine disorders like hypothyroidism, Cushing syndrome, etc.
3.Patient having tuberculosis, known case of HIV, leprosy, any type of Cancer.
4.Patients with infectious diseases such as chickenpox, dengue etc.
5.Haemoglobinopathies such as Sickle cell anaemia, Leukaemia and Thalassaemia.
6. Pregnant and lactating women
7.Patients with active bleeding disorders like Haemorrhoids, menorrhagia, gastro intestinal bleeding.
8.Anaemia in a case of defective absorption due to gastrectomy, sprue syndrome etc.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Panduta of Tvaka, Nakha, Netravartma, Jihva, Hastapadatala/Paleness of skin,eye,tongue,foot and palm.
Dourbalya/Generalised weakness
Hataanila/Reduction of digestive fire
Srama/Fatigue
Bhrama/Giddiness
Hrutspandana/Palpitations
|
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
08/03/2025 |
| 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="3" 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
|
This is a randomized comparative clinical study to evaluate the effect of hutabugadi choorna and moorvadi choorna in management of symptoms of pandu for 30 days this study comprises of two groups of 30 patients seected as inclusion and exclusion criteria study will be conducted in ALN Rao memorial ayurvedic hospitals in koppa koppa taluk chikmaglur 577126 karnataka India. |