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CTRI Number  CTRI/2021/11/038299 [Registered on: 26/11/2021] Trial Registered Prospectively
Last Modified On: 24/11/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative Study of Amalaki and Amalaki Loha in Anemia 
Scientific Title of Study   A Comparative Clinical Study to evaluate the efficacy of Amalaki and Amalaki Loha in Pandu Vyadhi 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sadhana Suresh Rangnekar 
Designation  M. D. Scholar 
Affiliation  Maharashtra Aarogya Mandal Sumatibhai Shah Ayurved Mahavidyalaya 
Address  OPD No 2 Kayachikitsa Department Ground Floor Maharashtra Aarogya Mandal Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune MAHARASHTRA 411028 India
OPD No 2 Kayachikitsa Department Ground Floor Maharashtra Aarogya Mandal Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune MAHARASHTRA 411028 India
Pune
MAHARASHTRA
411028
India 
Phone  7303911704  
Fax    
Email  sadhanarangnekar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jayashree N Tongaonkar 
Designation  M. D.  
Affiliation  Maharashtra Aarogya Mandal Sumatibhai Shah Ayurved Mahavidyalaya 
Address  OPD No 2 Kayachikitsa Department Ground Floor Maharashtra Aarogya Mandal Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune MAHARASHTRA 411028 India
OPD No 2 Kayachikitsa Department Ground Floor Maharashtra Aarogya Mandal Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune MAHARASHTRA 411028 India
Pune
MAHARASHTRA
411028
India 
Phone  9822829493  
Fax    
Email  jntayu@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sadhana Suresh Rangnekar 
Designation  M. D. Scholar 
Affiliation  Maharashtra Aarogya Mandal Sumatibhai Shah Ayurved Mahavidyalaya 
Address  Maharashtra Aarogya Mandal Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune MAHARASHTRA 411028 India
Maharashtra Aarogya Mandal Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune MAHARASHTRA 411028 India

MAHARASHTRA
411028
India 
Phone  7303911704  
Fax    
Email  sadhanarangnekar@gmail.com  
 
Source of Monetary or Material Support  
MAM Sumatibhai Shah Ayurved College Hadapsar Pune 
 
Primary Sponsor  
Name  Dr Sadhana Rangnekar 
Address  Maharashtra Aarogya Mandal Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar 
Type of Sponsor  Private medical college 
 
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 Sadhana Suresh Rangnekar  Sane Guruji Aarogya Kendra,  M A M s Sumatibhai Shah Ayurved Mahavidylaya Malwadi Hadapsar Pune
Pune
MAHARASHTRA 		 7303911704

sadhanarangnekar@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:D508||Other iron deficiency anemias. Ayurveda Condition: PANDUROGAH,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Amalaki   500 mg vati twice a day with anupan Madhu 
Intervention  Amalaki loha  500 mg vati twice a day with anupan Madhu 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1) “Pandu Vyadhi” will be diagnosed on the basis of cardinal symptoms of Pandu vyadhi (Panduta, Dourbalya, Agnimandya, Akshikuta Shotha, Hritspandan) and Hemogram.
2) Age: 18-45 Yrs. Irrespective of gender, religion, Socio - economic status, marital status
3) Hb % more than 8 gm% & less than normal i.e. Male -<13g / dl, Female – < 12g / dl.
4) MCV less than normal. [80 - 100 fl]
 
 
ExclusionCriteria 
Details  1.Known case of Endocrine disorders like Diabetes mellitus, hypothyroidism, Cushing syndrome, Chronic kidney disease.
2.Aplastic anaemia, sickle cell anaemia, haemophilia, thalassemia, beta Thalassemia, genetic blood disorders.
3.Pregnant and lactating lady.
4.Patient having Tuberculosis, known case of HIV, leprosy, any type of cancer.
5.Patient showing signs and symptoms of internal bleeding, haemorrhoids, menorrhagia, endometriosis.
6.Patient on immunosuppressant drugs, oral glucocorticoids. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1)To compare the efficacy of Amalaki and Amalaki Loha in Pandu vyadhi on the basis of change in haemogram and Serum Iron.
2) To compare the efficacy of Amalaki and Amalaki Loha in Pandu vyadhi on the basis of subjective parameters (Panduta, Dourbalya, Akshikutshotha, Hritspandan, Aayasena Shwas).
 		 30 day 
 
Secondary Outcome  
Outcome  TimePoints 
1)To study in detail the results of Amalaki and Amalaki Loha in Pandu Vyadhi.
2)To study the side effects (adverse effects) of Amalaki and Amalaki Loha if any. 		 30 day 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
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 
Date of First Enrollment (India)   29/11/2021 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Published in Peer reviewed Journal after completion of clinical trial 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
The title of study is - A Comparative Clinical Study to evaluate the efficacy of Amalaki and  Amalaki Loha in Pandu Vyadhi.

Anaemia is a Global public health problem affecting both developing and developed countries with major consequences on human health as well as social and economic development. Iron deficiency anaemia is by far the commonest nutritional cause of anaemia; it may be associated with a folate deficiency. Previous studies done using Amalaki churna have shown results in subjective  parameters but not as much desired effect on the objective parameters as Haemoglobin and Serum Iron levels. Using reference, Ayas is beneficial as mentioned in AshtangHhridayam. Thus, it has been decided to add Lohabhasma in Amalakichurna to evaluate and see the changes in haematological parameters. Side effects of oral allopathic iron preparations are constipation, abdomen discomfort, heart burn, epigastric pain, nausea, vomiting etc. Thus, to get a better alternative medicine this topic is selected. Amalaki Loha is not a new drug that has been discovered. It is a formulation of drugs (anubhutayog) having previously proven properties and can be considered as a proprietary ayurvedic medicine. 
 
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