| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:D508||Other iron deficiency anemias. Ayurveda Condition: PANDUROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other 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: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Ferrous Sulphate | Oral, 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). |
|
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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. |