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CTRI Number  CTRI/2021/01/030510 [Registered on: 15/01/2021] Trial Registered Prospectively
Last Modified On: 15/01/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Management of Anemia with Sammoha loha  
Scientific Title of Study   A STANDARD COMPARATIVE CLINICAL STUDY ON PANDUROGA W.S.R. TO IRON DEFICINCEY ANEMIA WITH SAMMOHA LOHA OVER FERROUS SULPHATE 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rajeshwari M S 
Designation  PG Scholar 
Affiliation  DGM Ayurvedic Medical College 
Address  Department of Kayachikitsa, Division G1, Room No 3. DGM Ayurvedia Medical college and hospital Post Graduate Studies and Research Center Gadag

Gadag
KARNATAKA
582103
India 
Phone  9632036382  
Fax    
Email  msrajeshwari312@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR R V Shettar  
Designation  Professor 
Affiliation  DGM Ayurvedic Medical College 
Address  Department of Kayachikitsa DGM Ayurvedia Medical college and hospital Post Graduate Studies and Research Center Gadag
DGM Ayurvedia Medical college and hospital Post Graduate Studies and Research Center Gadag
Gadag
KARNATAKA
582103
India 
Phone  9845613116  
Fax    
Email  shettar_dr@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Rajeshwari M S 
Designation  PG Scholar 
Affiliation  DGM Ayurvedic Medical College 
Address  Department of Kayachikitsa, Divisipon G1, Room 3. DGM Ayurvedia Medical college and hospital Post Graduate Studies and Research Center Gadag

Gadag
KARNATAKA
582103
India 
Phone  9632036382  
Fax    
Email  msrajeshwari312@gmail.com  
 
Source of Monetary or Material Support  
DGM Ayurvedic Medical College, Hospital and Research center. 
 
Primary Sponsor  
Name  nil 
Address  Nil 
Type of Sponsor  Other [Nil] 
 
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 Rajeshawri M S  DGM Ayurvedic Medical College. Gadag  Department of Kayachikitsa, Division G1, Room No 3.
Gadag
KARNATAKA 
9632036382

msrajeshwari312@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee   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  
Type  Name  Details 
Comparator Agent  Ferrous sulphate.  Dose - 150 mg frequency - Three times a day after food Anupana - jala duration - 30 days 
Intervention  Sammoha Loha   Dose - 250 mg Frequency - Three times a day after food Anupana - sukoshna jala. Duration - 30 days 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patient with symptoms of Panduta, Shrama, Bhrama, Arohana ayasa, Dourbalya, Aruchi, Pindkodwestana, Shoonakshi Koota Shota and Gatrashoola.
1. Patients of Panduroga between the age group of 10 – 60 years.
2. Hb% between 6 gm/dl - 10gm/dl.  
 
ExclusionCriteria 
Details  1. Known cases of Thalassemia, Sickle Cell Anemia, Pernicious Anemia.
2. Anemia associated with any malignancy.
3. Patients under chemotherapy and radiation treatment etc.
4. Patients suffering from DM and HTN.
5. Anemia due to hookworm infestation.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduction in subjective parameters and increase in objective parameters   in 2 months 
 
Secondary Outcome  
Outcome  TimePoints 
Increase in hemoglobin range and serum ferritin. Reduction in subjective parameters Panduta, Shrama, Bhrama, Arohana ayasa, Dourbalya, Aruchi, Pindakodwestana, Shoonakshi koota, Gatra shoola.   in 2 months  
 
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   N/A 
Date of First Enrollment (India)   16/01/2021 
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="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   purpose of study : â€œA STANDARD COMPARATIVE CLINICAL STUDY ON PANDUROGA W.S.R. TO IRON DEFICINCEY ANEMIA WITH SAMMOHA LOHA OVER FERROUS SULPHATE”   
Need for the study : Anemia is the most common and intractable nutritional problem in the world today. WHO has estimated that around 2 billion people across the world is suffering from Anemia. Anemia due to iron deficiency is the most prevalent type of Anemia. Iron Deficiency Anemia is one of the most prevalent forms of malnutrition. Globally, 50% of Anemia is attributable to iron deficiency and accounts for approximately 841,000 deaths annually worldwide. Africa and parts of Asia bears 71% of global mortality burden.  
The majority of iron deficiency is seen in growing children, adolescents, menstruating women, pregnant women and due to inadequate dietary intake of iron.  
As the name denotes the main feature of Panduroga is pandutva. Panduroga as mentioned in classics is a Pitta Pradana Vyadhi. According to Charaka it is one among the Rasavaha Srotodusti. Here there is Raktha Kshaya due to Pitta which reduces the Raktha Poshakamsha of Rasa. The signs and symptoms of Panduroga include Panduta, Shrama, Bhrama, etc. This description avails the correlation of Panduroga with Anemia in modern science. Iron deficiency Anemia is a disease that has similar symptoms Paleness, Weakness, Fatigue, constitutional symptoms, etiology and pathogenesis. 
Panduroga and Iron Deficiency Anemia have been studied in parallel to facilitate a better understanding of the disease and to devise a better management. This disease was chosen for the study due to its high incidence. Despite of many programs conducted by various organization and many medicines available for treating Anemia, it still remains as a burning nutritional problem. 
Oral iron salts are the most readily available way of replacing iron, ferrous sulphate is most effective and economical oral preparation. But about 10 – 20% patients will develop gastrointestinal side effects related to the ferrous sulphate these range from nausea, epigastric discomfort, vomiting, constipation and diarrhoea. Hence an attempt is made to compare the effect of Sammoha Loha over Ferrous Sulphate. 
With the reference of Rasendra Sara Sangraha Sammoha Loha is chosen for the present study. This is indicated in Panduroga and it contains drugs like Pippali, Maricha, Shunti, Chitraka, Amalaki, Vibhitaki, Hritaki, Vidanga, Lohabhasma, Abhrakabhasma and Ghrita. This has properties like bala, varna, agni vardhana, kamala, pandu rogahara, hridroga, shotahara, krimighna, hence the drug is chosen for the trial. Ferrous sulphate is taken as a standard drug for the comparison. 
Hypothesis :H0 - Sammoha Loha is not effective in Panduroga.  
H1 – Ferrous Sulphate is more effective in Panduroga than Sammoha Loha.  
H2 – Sammoha Loha is more effective in Panduroga than Ferrous Sulphate.  
 
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