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CTRI Number  CTRI/2024/12/078182 [Registered on: 16/12/2024] Trial Registered Prospectively
Last Modified On: 28/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Evaluate the efficacy of Lauhadi Modaka in the management of Panduroga (Iron Deficiency Anaemia)  
Scientific Title of Study   Randomized controlled clinical trial to evaluate the efficacy of Lauhadi Modaka in the management of Pandu(Iron deficiency Anaemia). 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrKumud bahurupi 
Designation  PG scholar 
Affiliation  C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011 
Address  OPD NO 13 Kayachikitsa Department C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra 431011

Aurangabad
MAHARASHTRA
431011
India 
Phone  08149308986  
Fax    
Email  kumudbahurupi1@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Amol Motiram Badarkhe 
Designation  Professor  
Affiliation  C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011 
Address  OPD NO 13 Kayachikitsa Department C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra 431011

Aurangabad
MAHARASHTRA
431011
India 
Phone  9960566536  
Fax    
Email  dr.amolb1986@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrKumud bahurupi 
Designation  PG Scholar 
Affiliation  C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011 
Address  OPD NO 13 Kayachikitsa Department C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra 431011

Aurangabad
MAHARASHTRA
431011
India 
Phone  08149308986  
Fax    
Email  kumudbahurupi1@gmail.com  
 
Source of Monetary or Material Support  
C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011 
 
Primary Sponsor  
Name  CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra  
Address  C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
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 Kumud bahurupi   CSMSS Ayurved Mahavidyalaya and Rugnalaya  OPD NO 13 Kayachikitsa Department C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra 431011
Aurangabad
MAHARASHTRA 		 08149308986

kumudbahurupi1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
CSMSS Ayurveda Mahavidyalay Kanchanwadi Aurangabad 431011  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
1Intervention ArmDrugClassical(1) Medicine Name: Lauhadi modaka, Reference: Vangsen samhita adhyaya 12 shloka 23, Route: Oral, Dosage Form: Modaka , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -takra), Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Navayas loha, Reference: Charak chikitsa 16 adhyaya shloka 70-71, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -madhu/ ghrita), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1. Patients having symptoms such as Daurbalya,Akshikutshotha,Panduta
Pindikodweshtan, Hrutspandana.

2. Patient having Hb%
more than 7 and less than 12gm/dl in females.
more than 8 & less than 13gm/dl in males.

 
 
ExclusionCriteria 
Details  1.Pregnancy induced Anaemia.
2. Patients present with known case of Sickle cell Anemia, Megaloblastic Anemia, Aplastic Anemia, Pernicious Anemia.
3 .Patients present with known case of any bleeding disorders,
Thrombocytopenia, Hemorrhoids, Thalesemia.

 
 
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 
Subjective criteria:-
1.Daurbalya will reduce
2.Akshikutashotha will reduce
3.Panduta
4.Pindikodweshtan will reduce
5.Hrutaspandana will reduce
 		 15th,30th,45 th day 
 
Secondary Outcome  
Outcome  TimePoints 
Hb%
MCH
MCHC
HCT
MCV
Haematocrit will be in normal limits
 		 15,30th,45th day 
 
Target Sample Size   Total Sample Size="92"
Sample Size from India="92" 
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)   16/12/2026 
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 Yet Recruiting 
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  

Iron deficiency anaemia is one of the common deficiency disease.In anaemia haemoglobin concentration falls below the accepted range depending upon age and gender. There are several types of anaemia amongst them iron deficiency anaemia is very common. Due to less dietary intake ,poor availability of iron, chronic blood loss, its prevalence is high.In Panduroga all three doshas are vitiated,but there is predominance of Pitta dosha,due to that Panduroga is pitta pradhan vyadhi.Due to excessive intake of oily,sour,hot,salty,pungent food, excessive excercise, daytime sleeping and emotions like krodha,bhay, shok pitta gets vitiated.Anaemia is public health problem that affects populations in both rich and poor countries .Globally anaemia affects 1.62 billion people, which corresponds to 24.8% of the population.Ayurveda has explained Panduroga in detail with its type, causes, symptoms and different aspects of treatment including shoshana, shamana, with various drug formulations and without sideeffectsalso they are economically affordable. Keeping all these factors in mind .Ayurvedic treatment for this disease may be more effective than modern medicine  Vangsena samhita described “Lauhadi Modaka” in the management of panduroga ,which has the property of Pitta shamana.The ingredients of Lauhadi Modaka are cheap and easily available.


 
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