| CTRI Number |
CTRI/2022/06/043305 [Registered on: 16/06/2022] Trial Registered Prospectively |
| Last Modified On: |
10/11/2022 |
| 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 |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sunita Mata |
| Designation |
Research Officer |
| Affiliation |
Central Council for research in Ayurvedic sciences |
| Address |
Room No. 121 61-65, opp. D Block, Janakpuri Institutional Area,
Janakpuri, New Delhi, Delhi 110058
South West
DELHI
110058
India
South West
DELHI
110058
India |
| Phone |
8010529320 |
| Fax |
|
| Email |
sunita.dr@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunita Mata |
| Designation |
Research Officer |
| Affiliation |
Central Council for research in Ayurvedic sciences |
| Address |
Room No. 121 61-65, opp. D Block, Janakpuri Institutional Area,
Janakpuri, New Delhi, Delhi 110058
South West
DELHI
110058
India
DELHI
110058
India |
| Phone |
8010529320 |
| Fax |
|
| Email |
sunita.dr@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunita Mata |
| Designation |
Research Officer |
| Affiliation |
Central Council for research in Ayurvedic sciences |
| Address |
Room No. 121 61-65, opp. D Block, Janakpuri Institutional Area,
Janakpuri, New Delhi, Delhi 110058
South West
DELHI
110058
India
DELHI
110058
India |
| Phone |
8010529320 |
| Fax |
|
| Email |
sunita.dr@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| CCRAS, Ministry of AYUSH Govt.of India, New Delhi, India |
|
|
Primary Sponsor
|
| Name |
Central Council for Research In Ayurvedic Sciences CCRASMinistry Of Ayush Govt Of India |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Avum Homeopathy
Anusandhan Bhavan No 61 65 Institutional Area Opp D Block
Janakpuri New Delhi 110058 India |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Praveen Kumar K S |
Central Ayurveda Research Institute, Guwahati |
Central Ayurveda Research Institute , AMHCP room,
Borsojai, Beltola,
Guwahati-781028
Kamrup
ASSAM |
9447506528
0361-2303714
drpraveenkumarks@gmail.com |
| Dr Seema Jain |
Central Ayurveda Research Institute, Punjabi Bagh New Delhi |
Central Ayurveda Research Institute,AMHCP room
Road No.66, Punjabi Bagh(West)
New Delhi – 110 026
West
DELHI |
8851677673
01125225546
drseemajain@yahoo.co.in |
| DrAmrish |
Raja Ramdeo Anandilal Podar (RRAP) Central Ayurveda Research Institute, Mumbai |
Raja Ramdeo Anandilal Podar Central Ayurveda Research Institute (under CCRAS, Ministry of AYUSH, Government of India)AMHCP room,
Podar Medical Campus, Dr. Annie Besant Road, Worli, Mumbai-400018, Maharashtra, India
Mumbai
MAHARASHTRA |
9028638650
22-24947822
vdamrish@gmail.com |
| Dr Amit Kumar |
Regional Ayurveda Research Institute, Gwalior |
Govt. Ayurvedic Hospital, AMHCP room,Amkho, Gwalior-474009
Gwalior
MADHYA PRADESH |
9805997571
07512430317
amitnegiayurveda@gmail.com |
| Dr Gopesh Sharma |
Regional Ayurveda Research Institute, Jammu |
Regional Ayurveda Research Institute under CCRAS, Ministry of AYUSH, Government of India),AMHCP room,
Rajinder Nagar,Ban Talab, Jammu-181123
Jammu
JAMMU & KASHMIR |
9015947900
0191-2546475
drgopeshsharma@rediffmail.com |
| Dr Alok Kumar Srivastava |
Regional Ayurveda Research Institute, Lucknow |
Regional Ayurveda Research Institute, AMHCP room,
INS -106
Sector-25,Indira Nagar
Lucknow -226016
Lucknow
UTTAR PRADESH |
9792913313
05222717801
drakspatt@gmail.com |
| DrU R Sekhar Namburi |
Regional Ayurveda Research Institute, Nagpur |
Regional Ayurveda Research Institute, AMHCP room,Near Gharkul Parisar, Near Venkatesh Nagar, NIT Complex
Nandanwan, Nagpur –440009 (Maharashtra)
Nagpur
MAHARASHTRA |
8055595355
7122714685
amhri.nagpur@gmail.com |
| Dr SINIMOL T P |
Regional Ayurveda Research Institute, Thiruvananthapuram |
Regional Ayurveda Research Institute ,AMHCP room,
Poojappura, Thiruvananthapuram Kerala-695012
Thiruvananthapuram
KERALA |
9446519427
0471-2342070
drsinitp@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee of Central Ayurveda Research Institute, Guwahati |
Approved |
| Institutional Ethical committee of Central Ayurveda Research Institute, New Delhi |
Approved |
| Institutional Ethical committee of Raja Ramdeo Anandilal Podar (RRAP) Central Ayurveda Research Institute, Mumbai |
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, Lucknow |
Approved |
| Institutional Ethical committee of Regional Ayurveda Research Institute, Thiruvananthapuram |
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 | 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: Albendazole 400 mg Hs stat (once only) initially | | 2 | Comparator Arm (Non Ayurveda) | | - | Control Group | Ferrous ascorbate, containing 100mg of elemental iron, and folic acid 1.5 mg (in combination) once daily after meal for 84 days. |
|
|
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 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 |
| i.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 score of FACIT –Fatigue scale disease specific symptoms
iii.Change in score of Epworth sleepiness scale
iv.Change in VAS score of general weakness, dizziness, palpitation
v.Change in bio-chemical 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 score of FACIT [baseline, 4th, 8th, 12th week and 16th week]
iii.Change in score of Epworth sleepiness scale [baseline, 4th, 8th, 12th week and 16th week]
iv.Change in VAS score of general weakness, dizziness, palpitation [ baseline, 4th, 8th, 12th week and 16th week]
|
|
|
Target Sample Size
|
Total Sample Size="320"
Sample Size from India="320"
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)
|
18/06/2022 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The study is being conducted to evaluate the
effect of Mandur Vatak and Drakshavaleha (ayurveda
medicines) in improving haemoglobin (gm/dl)
in moderate iron deficiency anemia. The participants of any sex and
of age between 18 to 55 years, belonging to any caste will
be selected from out-reach OPD in identified SC dominant areas. It is a Open label, interventional,
multicentre, randomized controlled study. Participants having Hemoglobin
ranging between 8 – 10.9 gm /dl, Hematocrit less than 41% in men
and less than 36% in women and Mean corpuscular volume less
than 80% will be taken into study. The duration of study will be 1 year with
sample size 320 (Group I -160 & Group II -160) . Primary
outcome of the study is change in hemoglobin level as compare to standard of
care.[Time frame: at baseline, and at the end of 12th week]. |