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CTRI Number  CTRI/2024/04/065540 [Registered on: 10/04/2024] Trial Registered Prospectively
Last Modified On: 04/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Effect of Ambasthaki calyx in the management of Pandu Roga (Iron Deficiency Anaemia) 
Scientific Title of Study   A Phytopharmacotherapeutic evaluation of Ambasthaki Hibiscus Sabdariffa Linn Sp.Pl. calyx in the management of Pandu Roga 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  Gitanjali Ambad 
Designation  MD Scholar 
Affiliation  Choudhary Brahm Prakash Ayurveda Charak sansthan Khera Dabar New Delhi South west DELHI 
Address  Room no 223 PG Department of Dravyaguna Vigyana Choudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar New Delhi South west DELHI
Choudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar New Delhi
South West
DELHI
110073
India 
Phone  07769998959  
Fax    
Email  gitanjaliambad@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Monika  
Designation  Assistant professor 
Affiliation  Choudhary Brahm Prakash Ayurveda Charak sansthan Khera Dabar New Delhi South west DELHI 
Address  Room no 239 PG Department of Dravyaguna Vigyana Choudhary Brahm Prakash Ayurveda Charak sansthan Khera Dabar New Delhi South west DELHI

South West
DELHI
110073
India 
Phone  7838241559  
Fax    
Email  monika.harmony@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Gitanjali Ambad 
Designation  MD Scholar 
Affiliation  Choudhary Brahm Prakash Ayurveda Charak sansthan Khera Dabar New Delhi South west DELHI 
Address  Room no 223 PG Department of Dravyaguna Vigyana Choudhary Brahm Prakash Ayurveda Charak sansthan Khera Dabar New Delhi South west DELHI

South West
DELHI
110073
India 
Phone  07769998959  
Fax    
Email  gitanjaliambad@gmail.com  
 
Source of Monetary or Material Support  
Choudhary Brahm Prakash Ayurved Charak Sansthan New Delhi 
 
Primary Sponsor  
Name  Choudhary Brahm Prakash Ayurved Charak Sansthan New Delhi 
Address  Ch. Brahm Prakash Ayurved Charak Sansthan Khera Dabar New Delhi 
Type of Sponsor  Research institution and hospital 
 
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 Gitanjali Ambad  Choudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar New Delhi  Room No.223 PG Department of Dravyaguna Vigyana Choudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar New Delhi South west DELHI
South West
DELHI 
07769998959

gitanjaliambad@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committie Choudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar New Delhi South West DELHI   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 ArmDrugOther than Classical(1) Medicine Name: Ambasthaki calyx churna , Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: -
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patients with symptoms of Pandu Roga. Patients with Hb% within level of 7-11 gm /dl. Patients of either sex with age group of 20-50 years.
 
 
ExclusionCriteria 
Details  Pandu Roga in age group below 20 years and above 50 years. Haemoglobin level less than 7gm/dl. Anaemia due to internal bleeding, external bleeding, gastric and duodenal ulcer, haemorrhoids, pregnancy induced Anaemia. Patients suffering from other systematic diseases like AIDS, Cancer, Tuberculosis, Diabetes Mellitus etc. Patient with history of disorders related with haemopoietic system like Sickle Cell Anaemia, Haemophilia. Patients suffering from other infectious diseases like Malaria, Jaundice etc. Pregnant woman and Lactating mothers. Other causes of Anaemia apart from iron deficiency, apparent by history, physical examination, laboratory tests. Patients with hepatic and renal dysfunction.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvement in the symptoms of Pandu Roga (Iron Deficiency Anaemia). Increase in the HB % level. Increase in the level of range of Iron profile  60 days 
 
Secondary Outcome  
Outcome  TimePoints 
The study will provide easily available, cost effective, safe treatment modality with lesser side effects.  60 days 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
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)   15/04/2024 
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="0"
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  

Anaemia is defined as haemoglobin (Hb) levels <12.0 g/dL in women and <13.0 g/dL in men. Haemoglobin is needed to carry oxygen and if you have too few or abnormal red blood cells, or not enough haemoglobin, there will be a decreased capacity of the blood to carry oxygen to the body’s tissues. Various reasons of anaemia are deficiencies in foliate, vitamins A, B12, haemoglobinopathies; and infectious diseases, but major reason of anaemia is iron deficiency. Iron is abundant in HB that carries oxygenated blood to various parts of the body. Iron Deficiency Anaemia occurs when iron losses or physiological requirements exceed absorption. Blood loss in females through the menses, or blood loss from GI tract, genitourinary tract, malabsorption, pregnancy, exceed use of NSAID etc. are the main causes for iron deficiency anaemia. In Ayurveda anaemia can be well correlated with Pandu roga. Pandu is pitta pradhana vyadhi associated with rasa and rakta dhatu. In short pandu roga means raktalpata. Pandu is a clinical condition characterized by whitish yellow discoloration of skin, eyes, nails, weakness, loss of appetite, skin dryness, dyspnoea etc. Hibiscus sabdariffa L., a member of the Malvaceae family, is an annual herb having amla pradhana madhur, tikta, kashaya rasa, Amla vipaka, Dipana property. Chemical composition of Ambashthaki calyx shows that it contains iron and vitamin c which are useful in the management of the Iron Deficiency Anaemia as iron will replace deficient iron on the body and vitamin c helps in the absorption of iron, so taking these points into consideration present study is being planned to evaluate effect of Ambasthaki calyx in the management of Iron Deficiency Anaemia. Total no of patients is 66. Ambasthaki calyx churna will be given 5gm twice a day with luke warm water after meal. Study design is single arm, single centred, interventional type, clinical study.

 
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