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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:D509||Iron deficiency anemia, unspecified. Ayurveda Condition: PANDUROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(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.
2Intervention ArmDrugClassical(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. 
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