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CTRI Number  CTRI/2021/07/034767 [Registered on: 12/07/2021] Trial Registered Prospectively
Last Modified On: 16/04/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   “A prospective community based study for the evaluation of Dhatri Lauha in Anemia (Pandu)” 
Scientific Title of Study   “A prospective community based study for the evaluation of Dhatri Lauha in Anemia (Pandu)” 
Trial Acronym  A prospective study on Anemia  
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(AYU) 
Affiliation  Central Council for Research in Ayurvedic Sciences , New Delhi 
Address  Dr Kalpana B Kachare, Central Council for Research in Ayurvedic Sciences , New Delhi, 1st Floor,Room No-121, 61-65, Institutional area, Opposite D block, Janakpuri

South West
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(AYU) 
Affiliation  Central Council for Research in Ayurvedic Sciences , New Delhi 
Address  Dr Kalpana B Kachare, Central Council for Research in Ayurvedic Sciences , New Delhi, 1st Floor,Room No-121, 61-65, Institutional area, Opposite D block, 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(AYU) 
Affiliation  Central Council for Research in Ayurvedic Sciences , New Delhi 
Address  Dr Kalpana B Kachare, Central Council for Research in Ayurvedic Sciences , New Delhi, 1st Floor,Room No-121, 61-65, Institutional area, Opposite D block, Janakpuri

South West
DELHI
110058
India 
Phone  09834410028  
Fax    
Email  kachare.kalpana@gmail.com  
 
Source of Monetary or Material Support  
Central Council for Research in Ayurvedic Sciences, New Delhi, 2nd Floor, 61-65, Institutional area, Opposite D block, Janakpuri-110058 
 
Primary Sponsor  
Name  Ministry of Tribal Affairs 
Address  New Delhi 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
Ministry of AYUSH  New Delhi  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 14  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ashok Sinha  Ayurveda Regional Research Institute, Gangtok  Dr. Ashok Sinha, Research Officer Ayu, THCRP Room, Ayurveda Regional Research Institute, Gangtok Tadung, Gangtok, Sikkim-737102
South
SIKKIM 		 9466448410

drashoksinha22@gmail.com 
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 Purnendu Panda  Central Ayurveda Research Institute, Bhubaneswar  Dr Purnendu Panda, Central Ayurveda Research Institute, Bhubaneswar, THCRP Room, Bharatpur, Near Kalinga Studio, Dist- Khorda, Bhubaneswar-751029, Odisha
Khordha
ORISSA 		 9777852889
0674-2387702
pandapurnendu02@yahoo.com 
Dr Raghavendra Naik  Central Ayurveda Research Institute,Bangalore  Dr Raghavendra Naik, Research Officer Ayu, THCRP room, #12, Uttarahalli ManavartheKaval, Uttarahalli (Hobli), Bangalore South (Tq.) Kanakapura Main Road, Talaghattapura Post, Bengaluru - 560109
Bangalore
KARNATAKA 		 8105683022

ayuraghu@gmail.com 
Dr P Srinivas  Dr.AchantaLakshmipathi Regional Ayurveda Research Institute, Chennai  Dr P Srinivas, Research Officer Ayu, Dr.Achanta Lakshmi pathi Regional Ayurveda Research Institute, Chennai, THCRP room,2nd Floor, VHS Campus, Taramani, Chennai, Tamilnadu. PIN: 600 113
Chennai
TAMIL NADU 		 9840879433

drsrinivaspitta@gmail.com 
Dr V B Kumawat  M.S. Regional Ayurveda Research Institute Jaipur  Dr V B Kumawat, THCRP Room, M.S. Regional Ayurveda Research Institute (RARI), Indira Colony, Bani Park, Jhotwara Road, Jaipur-302016
Jaipur
RAJASTHAN 		 8003514251

vinodbihari100@gmail.com 
Dr Rohit Rawate  Regional Ayurveda Research Centre,Tripura  135, Ramnagar Road, No.4, Opp. Raj Bhandar Agartala, Tripura – 799002
West Tripura
TRIPURA 		 9007729430

rohitkravte@rediffmail.com 
Dr Vipin Sharma  Regional Ayurveda Research Institute Jammu  Dr.Vipin Sharma, Research Officer Ayu, THCRP Room, Regional Ayurveda Research Institute Jammu, Rajinder Nagar, BanTalab, Jammu-181123
Jammu
JAMMU & KASHMIR 		 9899437195

Sharma.vipin@nic.in 
Dr K Nishanth  Regional Ayurveda Research Institute Vijayawada  Dr K Nishanth, Regional Ayurveda Research Institute Vijayawada, THCRP Room, New Rajiv Nagar, Payakapuram Vijayawada- 520015 Andhra Pradesh
Krishna
ANDHRA PRADESH 		 9946307403

dr.nishanth.k@gmail.com 
Dr Anil Avhad  Regional Ayurveda Research Institute, Ahmedabad   Dr Anil Avhad, Research officer-Ayu, Regional Ayurveda Research Institute, Ahmedabad, Block A & D, 2nd Floor, Bahumali Bhavan, Manjushree Mill Compound, Near Girdharnagar Over Bridge, Asarwa, Ahmedabad-380004
Ahmadabad
GUJARAT 		 9510176085

anilavhad4u@yahoo.com 
Dr Shyam Sing  Regional Ayurveda Research Institute, Gwalior   Dr Shyam Sing, Research Officer (Ayu) Regional Ayurveda Research Institute, Gwalior THCRP Room, Govt. Ayurvedic Hospital, Amkho, Gwalior-474009 Madhya pradesh
Gwalior
MADHYA PRADESH 		 9782560296

dr.shyam84@yahoo.in 
Dr U R Namburi  Regional Ayurveda Research Institute, Nagpur  Dr U R Namburi, Research Officer Ayu, THCRP Room, Regional Ayurveda Research Institute, Nagpur Near GharkulParisar, Near Venkatesh Nagar, NIT Complex Nandanwan, Nagpur – 440009 (Maharashtra)
Nagpur
MAHARASHTRA 		 8055595355

shilpasekhar2k5@yahoo.com 
Dr D S Rotwar  Regional Ayurveda Research Institute, Patana  Dr D S Rotwar, Research Officer Ayu., THCRP Room, Regional Ayurveda Research Institute, Patana RMRI Building “D” Block, AgamKuan, Patna-800007,
Patna
BIHAR 		 7987135761

dsrotwar7@gmail.com 
Dr Akash Lal   Regional Ayurveda Research Institute, Port Blair  Dr Akash Lal ,Research Officer Ayu Regional Ayurveda Research Institute, Port Blair, THCRP Room, Quarter No. NGII - 1/3, Chakkargaon (PO), Opp. Municipal Complex, Near Ganesh Temple, Chakkargaon, Port Blair, South Andaman-744112,
Andamans
ANDAMAN & NICOBAR ISLANDS 		 9447755650

akashlalm@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 13  
Name of Committee  Approval Status 
Institutional Ethical Committee- Central Ayurveda Research Institute Guwahati  Approved 
Institutional Ethical Committee- Central Ayurveda Research Institute Bangalore  Approved 
Institutional Ethical Committee- Central Ayurveda Research Institute Bhubaneswar  Approved 
Institutional Ethical Committee-Central Ayurveda Research Institute Guwahati (For THCRP-Tripura)   Approved 
Institutional Ethical Committee-Regional Ayurveda Research Institute Ahmadabad  Approved 
Institutional Ethical Committee-Regional Ayurveda Research Institute Chennai   Approved 
Institutional Ethical Committee-Regional Ayurveda Research Institute Gangtok   Approved 
Institutional Ethical Committee-Regional Ayurveda Research Institute Gwalior  Approved 
Institutional Ethical Committee-Regional Ayurveda Research Institute Jaipur   Approved 
Institutional Ethical Committee-Regional Ayurveda Research Institute Jammu  Approved 
Institutional Ethical Committee-Regional Ayurveda Research Institute Nagpur   Approved 
Institutional Ethical Committee-Regional Ayurveda Research Institute Patana  Approved 
Institutional Ethical Committee-Regional Ayurveda Research Institute Vijaywada  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:D539||Nutritional anemia, unspecified. Ayurveda Condition: PANDUROGAH,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dhatri Lauha  Dhatri Lauha - API, Part- I, 21:2 pg- 743-744 Dose: 500mg Twice daily. Rout of Administration: Oral Duration of Therapy: 12 weeks(3 month) Dosage form: Tablet Time of Administration: Twice daily just after food. Packing form: Pack of 60 tabs. Anupana: Honey  
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  i. Participants of scheduled Tribe community of any gender in the age group 18 to 55 years.
ii. Hemoglobin index (Hb gm %} ranging ≥8gm - ≤10gm.%)
iii. Willing to provide informed written consent.
 
 
ExclusionCriteria 
Details  i. Recent history of blood loss from the gastro intestinal or other sources in the form of Haematemesis, Melena, Bleeding Piles, Hemoptysis, Menorrhagia, etc.
ii. History or evidence of intestinal mal-absorption
iii. History of Major co-morbidity/ serious chronic Renal/ Hepatic/ cardiac/ pulmonary diseases etc.
iv. Known / diagnosed case of any other type of anaemia (sickle cell disease, thalassemia, other hemolytic anemia, bone marrow failure, etc). [apparent by history, physical examination, and/or laboratory tests if required.]
v. Patients on prolonged (> 6 weeks) medication for any chronic disease that may have an influence on the outcome of the study
vi. Patient with diagnosis/ known history of Myelodysplastic syndromes, cancer etc.
vii. Pregnant women/ women who are planning for conception/lactating women
viii. Patients already on iron supplements at present or during the last 3 months
ix. Any current medical condition, which the investigator considers would put the subject at unacceptable risk or affect study compliance.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
i. Mean Change in hemoglobin percentage from baseline.

 
Time frame: at baseline, 4th, 8th, 12th week and end of the 16th week
 
 
Secondary Outcome  
Outcome  TimePoints 
i. Assessment of changes in disease specific symptoms.
ii. Tolerability assessed by proportion of recruited participants remaining in the trial intervention.
iii. Change in FACIT –Fatigue scale.
 		 Time frame: at baseline, 4th, 8th, 12th week and end of the 16th week 
 
Target Sample Size   Total Sample Size="490"
Sample Size from India="490" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="490" 
Phase of Trial   N/A 
Date of First Enrollment (India)   13/07/2021 
Date of Study Completion (India) 31/03/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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)  

Objectives

·         Primary objective- To examine the role of Ayurvedic formulation Dhatri Lauha in Anaemia (Pandu)

·         Secondary objective-

i)       To assess the change in disease specific symptoms.

ii)     To evaluate the tolerability of Ayurvedic formulation Dhatri Lauha.

 

1.      Study Design : Interventional

2.      Sample Size: 490 ( i.e. 35 each centre)

3.      Duration of Study : 10 Month

4.      Interventions : Dhatri Lauha ( Anupan : Honey)

5.      Study initiated on -13th July 2021

6.      Study Completed on -31st March 2022

7.      Number of Cases Enrolled- 490

8.      Number of cases Completed- 478

9.      Number of Drop outs- 12


 
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