| CTRI Number |
CTRI/2022/06/043097 [Registered on: 08/06/2022] Trial Registered Prospectively |
| Last Modified On: |
21/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluation of efficacy and tolerability of select Ayurveda formulations in moderate Iron Deficiency Anemia |
Scientific Title of Study
Modification(s)
|
Evaluation of efficacy and tolerability of select Ayurveda formulations in moderate Iron Deficiency Anemia – A randomized controlled trial |
| Trial Acronym |
THCRP-IDA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kalpana B Kachare |
| Designation |
Research officer (Ayurveda) |
| Affiliation |
Central Council for Research in Ayurvedic Sciences, Ministry of Ayush |
| Address |
Central Council for Research in Ayurvedic Sciences
61-65, Institutional Area, opposit to D block
Ist Floor, room no. 121, Janakpuri
New Delhi
DELHI
110058
India |
| Phone |
09834410028 |
| Fax |
|
| Email |
kachare.kalpana@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kalpana B Kachare |
| Designation |
Research officer (Ayurveda) |
| Affiliation |
Central Council for Research in Ayurvedic Sciences, Ministry of Ayush |
| Address |
Central Council for Research in Ayurvedic Sciences
61-65, Institutional Area, opposit to D block
Ist Floor, room no. 121, Janakpuri
South West
DELHI
110058
India |
| Phone |
09834410028 |
| Fax |
|
| Email |
kachare.kalpana@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kalpana B Kachare |
| Designation |
Research officer (Ayurveda) |
| Affiliation |
Central Council for Research in Ayurvedic Sciences, Ministry of Ayush |
| Address |
Central Council for Research in Ayurvedic Sciences
61-65, Institutional Area, opposit to D block
Ist Floor, room no. 121, Janakpuri
South West
DELHI
110058
India |
| Phone |
09834410028 |
| Fax |
|
| Email |
kachare.kalpana@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Ministry of Tribal Affairs |
| Address |
New Delhi |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr S Dodamani |
Central Ayurveda Research Institute Bangalore |
Central Ayurveda
Research Institute
Bangalore #12,
Uttarahalli Manavarthe
Kaval, Uttarahalli
(Hobli), Bangalore
South (Tq.) Kanakapura
Main Road,
Talaghattapura Post,
Bengaluru - 560109
Telephone: 080-295350
34(Office)/29635035(H
ospital)
Bangalore
KARNATAKA |
9448085818
shd_ayu@yahoo.co.in |
| Dr Ekta Dogra |
Central Ayurveda Research Institute Guwahati |
Dr Ekta Dogra,
Research Officer Ayu
Central Ayurveda
Research Institute
Guwahati, THCRP
Room, Borsojai,
Beltola,
Guwahati-781028.
Phone No.
0361-2303714
Kamrup
ASSAM |
7696863979
dr.ektadogra@gmail.com |
| Dr M M Sharma |
Regional Ayurveda Research Institute Gwalior |
Dr M M Sharma, Research Officer (AYU.) Regional Ayurveda
Research Institute,
Gwalior THCRP Room,
Govt. Ayurvedic
Hospital, Amkho,
Gwalior-474009
Madhya Pradesh
Gwalior
MADHYA PRADESH |
9810691874
mmsharmajpr@gmail.com |
| Dr Vipin Sharma |
Regional Ayurveda Research Institute Jammu |
Regional Ayurveda
Research Institute
Jammu Rajinder
Nagar,Ban Talab,
Jammu-181123 Phone
and Fax No.
0191-2546475,
Jammu
JAMMU & KASHMIR |
9899437195
rariud.jammu@gmail.com |
| Dr S Namburi |
Regional Ayurveda Research Institute Nagpur |
Regional Ayurveda
Research Institute
Nagpur Near Gharkul
Parisar, Near
Venkatesh Nagar, NIT
Complex Nandanwan,
Nagpur – 440009
(Maharashtra) Phone
No. 0712-2714230
Nagpur
MAHARASHTRA |
8055595355
shilpasekhar2k5@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee of Central Ayurveda Research Institute Banglore |
Approved |
| Institutional Ethical committee of Central Ayurveda Research Institute Guwahati |
Approved |
| Institutional Ethical committee of Regional Ayurveda Research Institute Gwalior |
Approved |
| Institutional Ethical committee of Regional Ayurveda Research Institute Jammu |
Approved |
| Institutional Ethical Committee of Regional Ayurveda Research Institute Nagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:D509||Iron deficiency anemia, unspecified. Ayurveda Condition: PANDUROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | control group | Ferrous ascorbate (containing 100mg of elemental iron and folic acid 1.5 mg in combination) will be given once daily after a meal for 84 days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Mandur Vatak ,, Reference: AFI-part-I -19:2 Pg- 252, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 12 Weeks, anupAna/sahapAna: Yes(details: Water), Additional Information: -(2) Medicine Name: Drakshavaleha, Reference: AFI, Part – I, 3;15, pg- 40, , Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 12 Weeks, anupAna/sahapAna: Yes(details: Water), Additional Information: - |
|
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
i. Participants of age between 18 to 55 years of any sex.
ii. Hemoglobin ranging between 8 to 10.9 gm/dl
iii. Hematocrit less than 41% in men and less than 36% in women
iv. Mean corpuscular volume less than 80%
v. Willing to provide informed written consent for participation in the study
|
|
| ExclusionCriteria |
| Details |
i. Recent history of severe acute or chronic blood loss from the gastro intestinal or other sources in the form of Haematemesis, Melena, Bleeding Piles, Hemoptysis, Menorrhagia, surgery, trauma, etc.
ii. Participants suffering from megaloblastic anemia (pernicious anemia) (Serum Vit. B12<150 pg/ml) or Hypothyroidism (TSH>10 mIU/L)
iii. Patients already on iron supplements at present or during the last 3 months
iv. Known case of disease conditions with intestinal malabsorption, alcohol use disorder (AUD) (CAGE score >2), anaemia due to chronic disease and medications, Thalassemia, Sideroblastic anemia, sickle cell, cold hemoglobinuria (Donath-Landsteiner hemolytic anemia), cold agglutinin disease (cold antibody hemolytic anemia), and other hemolytic anemias disseminated intravascular coagulation (DIC), Bone marrow suppression (aplastic anemia and myelophthisic anemia), Myelodysplastic syndromes, mechanical heart valves, hemolytic uremic syndrome (HUS), etc.
v. Known case of other major co-morbidities like chronic cardiac/ pulmonary diseases, malignancy, etc.
vi. Patients with concurrent serious Hepatic Dysfunction (defined as AST and/or ALT > 3 times of the upper normal limit) or Renal Dysfunction (defined as S. creatinine > 1.2mg/dl)
vii. Patients on prolonged (> 6 weeks) medication (steroids, immune-suppressants, disease modifying agents, chemotherapy etc.) for any chronic disease that may have an influence on the outcome of the study
viii. Pregnant women or women who are planning for conception or lactating mothers
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Change in hemoglobin level as compare to standard of care. |
at baseline, and at the end of 12th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
i.Proportion of participants achieving a hemoglobin increase of ≥2 g dL
ii. Change in a score of FACIT –Fatigue scale disease-specific symptoms ]
iii. Change in a score of the Epworth sleepiness scale
iv. Change in VAS score of general weakness, dizziness, palpitation
v.Change in biochemical parameters
vi. Occurrence of adverse events in both groups
vii. Comparison of Number and reasons of loss to follow-ups in both groups
viii. Compliance of interventions in both groups
|
i.Proportion of participants achieving a hemoglobin increase of ≥2 g dL−1 at any time from Baseline to Week 12 in both groups
ii. Change in a score of FACIT [baseline,4th,8th,12th, and 16th week]
iii. Change in the score of Epworth sleepiness scale [baseline,4th,8th,12th, and 16th week]
iv. Change in VAS score of general weakness, dizziness, palpitation [baseline,4th,8th,12th, and 16th week]
|
|
|
Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
Final Enrollment numbers achieved (Total)= "240"
Final Enrollment numbers achieved (India)="240" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/06/2022 |
| Date of Study Completion (India) |
30/03/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
| Anemia is the most common hematological disorder and is one of the most common conditions seen in clinical practice. Iron deficiency anemia is the most common cause of anemia. Most the anemia are easy to treat and thereby improve a person’s productivity. Anemia management can range from simple to complex based on the underlying condition causing it. The most common reason for non-compliance with Iron therapy was found to be “forgetfulness†(63.0%) followed by “side effects†(49.5%) in a study. However another study showed that the leading reported reasons for non-adherence were side effects (63.3%). The present study will explore the effect of the combination of two classical Ayurveda formulations viz., Mandur Vatak and Drakshavaleha on the level of hemoglobin in patients with moderate anemia without exhibiting side effects as compared to the standard of care. If found effective (non-inferior), it could be the first study to document the efficacy and safety of said formulations scientifically. |
|