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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:D572||Sickle-cell/Hb-C disease. Ayurveda Condition: PANDUROGAH, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
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. |