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CTRI Number  CTRI/2024/04/065535 [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   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Clinical Trial to study the effect of Kokilaksha Extract in the management of Iron Deficiency Anaemia 
Scientific Title of Study   "An Open Labelled Active Controlled Randomized Clinical Study to Evaluate the Efficacy of Ethanolic Extract of Kokilaksha (Asteracantha longifolia Nees.) in the Management of Iron Deficiency Anemia" 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ankita Baria 
Designation  PG Scholar 
Affiliation  Parul Institute of Ayurveda 
Address  OPD 116 Department of Kayachikitsa Parul Ayurved Hospital Parul University AP Limda Tal Waghodia Vadodara Gujarat

Vadodara
GUJARAT
391760
India 
Phone  07069490562  
Fax    
Email  bariaankita581@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rinjin G Krishna 
Designation  Associate Professor 
Affiliation  Parul Institute of Ayurveda 
Address  OPD 116 Department of Kayachikitsa Parul Ayurved Hospital Parul University AP Limda Tal Waghodia Vadodara Gujarat

Vadodara
GUJARAT
391760
India 
Phone  8921093277  
Fax    
Email  rinjin.krishna17658@paruluniversity.ac.in  
 
Details of Contact Person
Public Query
 
Name  Dr Rinjin G Krishna 
Designation  Associate Professor 
Affiliation  Parul Institute of Ayurveda 
Address  OPD 116 Department of Kayachikitsa Parul Ayurved Hospital Parul University AP Limda Tal Waghodia Vadodara Gujarat


GUJARAT
391760
India 
Phone  8921093277  
Fax    
Email  rinjin.krishna17658@paruluniversity.ac.in  
 
Source of Monetary or Material Support  
Parul Institute of Ayurved , Parul University  
 
Primary Sponsor  
Name  Principal Parul Institute of Ayurved 
Address  Faculty of Ayurved, Parul University AP Limda TAL Waghodia DIST Vadodara Gujarat 
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 Ankita Baria  Parul Institute of Ayurved  OPD 116 Department of Kayachikitsa Parul Ayurved Hospital Parul University AP Limda Tal Waghodia Vadodara Gujarat
Vadodara
GUJARAT 
7069490562

bariaankita581@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Parul Institute of Ayurved- Institutional Ethics 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  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Ethanolic Extract of Kokilaksha, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: -
2Comparator Arm (Non Ayurveda)-Ferrous SulphateOral, 200mg OD (Once a Day) After food
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients fulfilling the diagnostic criteria of Iron Deficiency Anemia.
a. Based on Symptoms
b. Hemoglobin less than 130gm/L in males, less than 120gm/L in Females, less than 110gm/L in pregnancy.
c. Sr. Ferritin Reduced, Male:24 to 336ng/L, Female:24 to 336ng/L.
d. TIBC Raised 262 to 474mcg/dl.
e. Sr. Iron Reduced, women:26 to 170, Men:76 to 198.
f. MCV Low 80-100 Femtolitre.
g. Mentzer’s index - greater than 13 Iron Deficiency anemia.
2. Patients belonging to age group of 18 -60 years (both inclusive) of either sex irrespective of religion, socio economic status, etc.
3. Patient willing and able to participate in the study. 
 
ExclusionCriteria 
Details  1. Patients with history of congenital disorders related with haemopoietic system like SCA, Leukemia & hemophilia.
2. Patients with history of other systemic diseases like uncontrolled diabetes mellitus and hypertension.
3. Patients suffering from disorder of the GIT system associated with Gastrointestinal bleeding like colorectal malignancy, gastritis, peptic ulceration & inflammatory bowel disease.
4. Patients on chronic use of aspirin & NSAIDS.
5. Pregnant & lactating women.
6. Immunocompromised Patients-HIV.
7. Patients on prolonged medication (more than 6 weeks) with corticosteroids, or any other drugs that may have influence on the outcome of the study.
8. Patients who are currently participating in any other clinical trials (since last 2 months). 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Changes in the Complete Blood Count between the group (Pre and Post)
2. Changes in the Total Iron Binding Capacity between the group (pre and post)
3. Changes in the Serum Iron between the group (pre and post)
 
Baseline Visit (Day 0) and Day 60  
 
Secondary Outcome  
Outcome  TimePoints 
Compare the efficacy of ethanolic extract of Kokilaksha with ferrous sulphate on CBC, Serum Iron, TIBC. in the Patients of Iron Deficiency Anemia  Baseline, Day 15, Day 30, Day 45, Day 60 
Clinical sign & symptoms of Iron deficiency anemia viz. Pallor, Weakness, Fatigue, Anorexia, Palpitations, Dyspnoea, Reduced Exercise capacity, Headache, Giddiness etc. Will be given Scoring pattern & will be analysed before, during & after treatment   Baseline visit, Day 0 ,Day 15, Day 30, Day 45, Day 60 
 
Target Sample Size   Total Sample Size="68"
Sample Size from India="68" 
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 3 
Date of First Enrollment (India)   25/04/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  
2 billion people – over 30% of the world’s population – are anaemic, many due to iron deficiency. Iron deficiency is the most common and widespread nutritional disorder in the world. In India too, Nutritional iron deficiency is the commonest cause of anemia. It is the only nutrient deficiency which is significantly prevalent in Industrialized Countries and in resource-poor areas, which is frequently exacerbated by infectious diseases. Malaria, HIV/AIDS, hookworm infestation, schistosomiasis, and other infections such as tuberculosis are particularly important factors contributing to the high condition, constituting a public health condition of epidemic proportions affecting a large number of children and women in developing countries. Iron deficiency anemia reduce the work capacity of individuals and entire populations, bringing serious economic consequences and obstacles to national development. Overall, it is the most vulnerable, the poorest and the least educated that are disproportionately affected by iron deficiency, and it is they who stand to gain the most by its reduction. In Ayurveda classics we don’t get any direct reference of Iron deficiency anemia but on symptom analysis, we can try to corelate it with Pandu Roga because of the predominance of Panduta (pallor) in the whole body. A prominent diagnostic feature of Pandu Roga is the pallor on the skin which occurs due to the quantitative and qualitative deficiency of Rasa and Rakta Dhatu caused either in the form of deficiency of haemoglobin and/or red blood cells (RBCs). Considering Panduta (pallor) as the predominant sign, the disease is termed as Pandu Roga. The regular response of iron deficiency anemia to adequate amounts of iron is an important diagnostic and therapeutic feature. Oral administration of simple ferrous salts provides inexpensive and satisfactory therapy. But all allopathic iron preparations are gastric irritant and common side effects of oral iron include nausea, abdominal pain and either constipation or diarrhoea. Ferrous sulphate usually causes severe gastrointestinal side effects like gastritis, constipation/diarrhoea. Parenteral iron therapy may be required if iron cannot be absorbed from intestine and patient experiences intolerable gut symptoms. In Ayurved classics, thorough approach to the treatment of Pandu Roga has been described from Samhita Kala to Adhunika Kala. Various Shodhana and Shamana treatments are enumerated in all the classics and Samgraha Granthas. Various formulations advocated in Ayurved literature are being used successfully in the management of Pandu Roga as well as Iron Deficiency Anemia. Human studies on use of Extract of herbal drug in iron deficiency anemia are lacking. Animal Study have been done on ethanolic extract of Kokilaksha in iron deficiency anemia which yielded significant improvement in erythrocyte count, haemoglobin content, leukocytes count and haematocrit values etc. It is obvious from the foregone introduction that the available contemporary management of iron deficiency anemia, even though being cheap is not devoid of side effects. On the other hand, there are so many Ayurvedic formulations in clinical practice which are not used in routine clinical practices. Documented data of their therapeutic effects are necessary to be highlighted for the social benefits. Another fact to be considered as the main approach for treating anemia is iron supplementation without correcting the metabolism whereas according to Ayurved Pandu is a Pitta dominant Tridoshaja disorder with involvement of vitiation of Rasavaha Srotas. The symptoms of Rasavaha Srotas vitiation are similar to the symptoms of Kapha vitiation. Thus, to reverse the Samprapti (pathogenesis), such a formulation is needed which can counteract Pitta-Kapha and act at Srotas level and correct the metabolism thereby increasing iron absorption. Keeping this in mind for the present study, ethanolic extract of Kokilaksha and ferrous sulphate were selected for the clinical trials in the Iron Deficiency Anemia. Hence, it is planned to check the role of these drugs through an open labelled active controlled randomised clinical trial.
 
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