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CTRI Number  CTRI/2023/11/060293 [Registered on: 28/11/2023] Trial Registered Prospectively
Last Modified On: 27/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   To study to observe the lakshanas of Doshaja Pandu in patients suffering from sickle cell anaemia. 
Scientific Title of Study   An observational study to assess the lakshanas of Doshaja Pandu in known cases of sickle cell 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  Nidhi Kevalsingh Gaharwar 
Designation  PG Scholar 
Affiliation  PDEAs College of Ayurved and Research Centre,Nigdi,Pune. 
Address  Ayurved Rugnalay and Sterling Multispeciality Hospital Pathology Lab Room no 115 Sector No 27 Pradhikaran Nigdi Pune
PDEAs College of Ayurved and Research Centre Sector 25 Pradhikaran Nigdi Pune
Pune
MAHARASHTRA
411044
India 
Phone  8308715892  
Fax    
Email  nidhigaharwar11@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Nidhi Kevalsingh Gaharwar 
Designation  PG Scholar 
Affiliation  PDEAs College of Ayurved and Research Centre,Nigdi,Pune. 
Address  Ayurved Rugnalay and Sterling Multispeciality Hospital Pathology Lab Room no 115 Sector No 27 Pradhikaran Nigdi Pune
PDEAs College of Ayurved and Research Centre Sector 25 Pradhikaran Nigdi Pune
Pune
MAHARASHTRA
411044
India 
Phone  8308715892  
Fax    
Email  nidhigaharwar11@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rajesh H Mhaske 
Designation  Associate Professor 
Affiliation  PDEAs College of Ayurved and Research Centre Nigdi Pune 
Address  Ayurved Rugnalay and Sterling Multispeciality Hospital Pathology Lab Room no 115 Sector No 27 Pradhikaran Nigdi Pune
PDEAs College of Ayurved and Research Centre Sector 25 Pradhikaran Nigdi Pune
Pune
MAHARASHTRA
411044
India 
Phone  9130805556  
Fax    
Email  dr.rajeshmhaske@gmail.com  
 
Source of Monetary or Material Support  
PDEAs College of Ayurved and Research Centre Sector 25 Pradhikaran Nigdi Pune 
 
Primary Sponsor  
Name  Dr Nidhi Kevalsingh Gaharwar 
Address  PDEAs College of Ayurved and Research Centre Sector 25 Pradhikaran Nigdi Pune 
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 Nidhi Kevalsingh Gaharwar  Ayurved Rugnalay and Sterling Multispeciality Hospital  Ayurved Rugnalay and Sterling Multispeciality Hospital pathology lab room no. 115Sector 27 Nigdi Pune
Pune
MAHARASHTRA 
8308715892

nidhigaharwar11@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:D572||Sickle-cell/Hb-C disease. Ayurveda Condition: PANDUROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1 Known case of sickle cell anaemia patient on the basis of RBC morphology
2 Irrespective of sex caste socio-economical class and marital status  
 
ExclusionCriteria 
Details  1 Sickle cell anaemia patient having multiple organ failure and patients on ventilator
2 Any other genetic disorders any other type of anaemia like iron deficiency pernicious aplastic anaemia 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the Doshaj Pandu lakshanas in known case of sickle cell anaemia  One Time  
 
Secondary Outcome  
Outcome  TimePoints 
Not applicable   Not applicable  
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   05/12/2023 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Ayurveda is the most ancient system of medicine. In the classification the disease Pandu felt in the group of varna in which there is a significant change in the normal colour of the body. The detail description of Panduroga and its classification starts from ayurvedic Samhitas. According to ayurveda the word Pandu denotes pale yellowish white colour. It is a disease in which person becomes pallor due to deficiency of Rakta dhatu in the body. Most of the acharyas accepted the disease under five categories Vataj, Pittaj, Kaphaj, Sannipataj, Mrudbhakshanjanya.

The Panduta means pallor on the skin, which is the cardinal sign found in anaemia according to modern science. Anaemia is defined as a haemoglobin concentration in blood below the lower limit of the normal range for the age and sex of the individual. A condition, in which the blood does not have enough healthy red blood cells.

Anaemia results from a lack of red blood cells or dysfunctional red blood cells in the body this leads to reduced oxygen flow to the body organs. In general anaemia seen as genetically, nutritional or blood loss disorder. Sickle cell anaemia is the type of anaemia which is a genetic disorder. The most important and widely prevalent type of haemoglobinopathy is due to the presence of sickle haemoglobin (Hbs) in the red blood cells. The red cells with Hbs develop ’Sickling’ when they are exposed to low oxygen tension sickle syndromes have the highest frequency in black race.

Although sickle cell anaemia is a genetic disorder but if one can correlate sickle cell anaemia with Doshaj pandu lakshana, it will help in early diagnosis and nidanparivarjana can be advice. Also it will help to give a supportive treatment according to type of Doshaj pandu correlated with sickle cell anaemia, hence this topic will be selected.

 
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