| CTRI Number |
CTRI/2023/11/060271 [Registered on: 28/11/2023] Trial Registered Prospectively |
| Last Modified On: |
24/11/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Punarnavadi Mandura vs Punarnavadi Mandura-Drakshavaleha vs Iron Folic Acid (IFA) in Iron deficiency anemia among non-pregnant women of reproductive age group |
|
Scientific Title of Study
|
Efficacy and safety of Punarnavadi Mandura alone and in combination with Drakshavaleha compared to iron folic acid in the treatment of moderate iron deficiency anaemia among non-pregnant women of reproductive age group: a community-based three arm multicentre randomized controlled trial |
| 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 Tanu Anand |
| Designation |
Scientist E |
| Affiliation |
Indian Council of Medical Research |
| Address |
Indian Council of Medical Research, V Ramalingaswami Bhawan, Ansari Nagar, New Delhi
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
tanu.anand@icmr.gov.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tanu Anand |
| Designation |
Scientist E |
| Affiliation |
Indian Council of Medical Research |
| Address |
Indian Council of Medical Research, V Ramalingaswami Bhawan, Ansari Nagar, New Delhi
South
DELHI
110029
India |
| Phone |
9811028964 |
| Fax |
|
| Email |
tanu.anand@icmr.gov.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tanu Anand |
| Designation |
Scientist E |
| Affiliation |
Indian Council of Medical Research |
| Address |
Indian Council of Medical Research, V Ramalingaswami Bhawan, Ansari Nagar, New Delhi
South
DELHI
110029
India |
| Phone |
9811028964 |
| Fax |
|
| Email |
tanu.anand@icmr.gov.in |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research & Central Council for Research in Ayurvedic Sciences |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
Indian Council of Medical Research, V Ramalingaswami Bhawan, Ansari Nagar, New Delhi |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Central Council for Research in Ayurvedic Sciences |
Central Council for Research in Ayurvedic Sciences, Ministry of AYUSH, Jawahar Lal Nehru Bhartiya Chikitsa Avum Homeopathy Anusandhan Bhavan, No.61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi - 110058 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anindo Majumdar |
All India Institute of Medical Sciences (AIIMS) Bhopal |
Department of Community Medicine & Family Medicine
Bhopal
MADHYA PRADESH |
9487635186
anindo.cfm@aiimsbhopal.edu.in |
| Dr Gomathi R |
All India Institute of Medical Sciences (AIIMS) Bibinagar |
Department of Community Medicine & Family Medicine
Hyderabad
TELANGANA |
8883422073
gmthramaswamy@gmail.com |
| Dr Manoj Kumar Gupta |
All India Institute of Medical Sciences (AIIMS) Jodhpur |
Community Medicine & Family Medicine
Jodhpur
RAJASTHAN |
8003996087
drmkgbhu@gmail.com |
| Dr Puneet Misra |
All India Institute of Medical Sciences (AIIMS) New Delhi |
Department of Community Medicine
South
DELHI |
9810696386
doctormisra@gmail.com |
| Dr Chandan N |
ICMR - National Institute of Traditional Medicine (ICMR-NITM) Belagavi |
ICMR - National Institute of Traditional Medicine
Belgaum
KARNATAKA |
9731919091
chandan.n@icmr.gov.in |
| Dr Aditi Apte |
KEM Hospital Research Centre Pune |
Department of Community Medicine
Pune
MAHARASHTRA |
9975950227
aditi.apte@kemhrcvadu.org |
| Dr Abhishek Raut |
Mahatma Gandhi Institute of Medical Sciences (MGIMS) Wardha |
Department of Community Medicine
Wardha
MAHARASHTRA |
7083170552
abhishekraut@mgims.ac.in |
| Dr Lakhan Manjee |
Rajendra Institute of Medical Sciences (RIMS) Ranchi |
Department of Pharmacology
Ranchi
JHARKHAND |
9431402029
drlakhan35@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS, Bibinagar |
Submittted/Under Review |
| Institutional Ethics Committee, AIIMS, Jodhpur |
Submittted/Under Review |
| Institutional Ethics Committee, AIIMS, New Bhopal |
Submittted/Under Review |
| Institutional Ethics Committee, AIIMS, New Delhi |
Approved |
| Institutional Ethics Committee, MGIMS, Sevagram |
Approved |
| Institutional Ethics Committee, RIMS, Ranchi |
Approved |
| Institutional Ethics Committee,KEMHRC, Pune |
Submittted/Under Review |
| Institutional Human Ethics Committee, ICMR-NITM, Belagavi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E00-E89||Endocrine, nutritional and metabolic diseases. Ayurveda Condition: Anaemia, (2) ICD-10 Condition:E611||Iron deficiency. Ayurveda Condition: PANDUROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Iron Folic Acid | Medicine Name: Ferrous Sulfate & Folic Acid, Route: Oral, Dosage Form: Tablets, Dose: Ferrous Sulphate 200(mg), Folic acid 500 (microgram) Frequency: BID, Duration: 90 Days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Punarnavadi Mandura, Reference: Agnivesha. Verse 93-96, Chapter 16, Chikitsa Sthana. In: Charaka Samhita elaborated by Charaka and Drdhabala with the Ayurveda Dipika commentary by Chakrapanidatta and Vidyotini Hindi commentary by Pt Kashinath shastri. Reprint 2016. Varanasi: Chaukhamba Sanskrit Sansthan; p. 426–7. 50. Vrinda. Vrinda Madhava with Kusumavali Hindi commentary by Srikantha Data. In: 1894th ed. Pune: Anand Asharam; p. 28–30. 51. Sodhal. Gada Nigraha with Vidyotini Hindi commentary by , Route: , Dosage Form: , Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Drakshavaleha, Reference: 37. Sushrutha A. Nibandha Sangraha commentary of Dalhanaachrya. In: Acharya VJ, editor, Sushrutha Samhita. 1st ed. Varanasi: Chaukambha Surabharti Prakashana; 2002. p. 252–824. 38. Vagbhata A. Sarvangasundara commentary by Arunadutta and Ayurvedarasayana commentary by Hemadri. In: Acharya B, Vaidya HP, editor Ashtanga Hridaya. 1st ed. Varanasi: Chaukhambha Orientalia; 2014. p. 169–956. , Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -lukewarm water), Additional Information: -half an hour after foo |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Female |
| Details |
1. Non-pregnant, non-lactating women of age group 18 to 49 years
2. Haemoglobin level 8 to 10.9 gm/dl
3. Serum Ferritin less than 15 µg /L
4. Women who are willing to use a reliable method of contraceptive to avoid pregnancy for next 6 months.
5. Women not planning to move residence/migrate within the next 6 months
|
|
| ExclusionCriteria |
| Details |
1. Known case of any other forms of anaemia
2. Any acute illness within last 14 days
3. Women having attained menopause or reporting symptoms suggestive of menopause
4. Women with known case of diabetes mellitus orHbA1c more than 6.5 percent
5. Known allergy to iron and related products
6. Women with known liver and kidney disorders
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in mean hemoglobin at the end of intervention of 90 days among non-pregnant moderately anaemic (Hb: 8-10.9 g/dL) women of reproductive age group (18-49 years) receiving Purnarnavadi Mandura alone or Purnarnavadi Mandura in combination to Drakshavaleha, or Ferrous Sulphate and folic acid combination. |
Baseline, 90 days and 180 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Change in mean hemoglobin, haematological parameters (haematocrit, MCV, MCH & MCHC) & Iron indices (TIBC, Serum Iron, transferrin saturation & serum ferritin)
at the end of 90 days of treatment & at 180 days follow up from baseline.in non-pregnant moderately anaemic (Hb:8-10.9 g/dL) women of reproductive age group (18-49 years) receiving Punarnavadi Mandura alone with those receiving Punarnavadi Mandura in combination with Drakshavaleha.
2. Compare the safety (incidence of adverse events) & change in quality of life score using Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale at the end of 90 days of treatment & at 180 days follow up from baseline in two intervention arms with active control arm. |
90 & 180 days from baseline |
|
|
Target Sample Size
|
Total Sample Size="3912"
Sample Size from India="3912"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
02/12/2023 |
| 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 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 among women in reproductive
age group continues to be a global public health problem with iron deficiency
being one of the common aetiology. There has been renewed commitment towards
prevention and control of anaemia given the SDG target of reduction of anaemia
among women of reproductive age by 2030 as a Global Nutrition Target. The
National Health Policy of India (NHP) 2017 has also acknowledged the burden of
this micronutrient deficiency and laid emphasis on interventions to address it.
While Iron Folic acid (IFA) has been the mainstay of iron deficiency anemia (IDA)
treatment since 1970’s, yet the poor uptake and adherence to iron and folic
acid tablets has been a major challenge. There has been a growing popularity of
natural plant-based products owing to the modest cost, low level of
technological input and acceptance. Ayurveda offers several formulations for
the management of IDA and they have also been used in the health programs
earlier. These interventions have shown encouraging responses in terms of
improving haemoglobin levels, safety and quality of life. If proved that they
can benefit the patients with iron deficiency in a way similar to IFA, this
will provide another choice of drug for these patients. Thus, the proposed
study aims at assessing the efficacy and safety of Ayurvedic formulation
compared to standard care in IDA. |