| CTRI Number |
CTRI/2025/06/088446 [Registered on: 09/06/2025] Trial Registered Prospectively |
| Last Modified On: |
02/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical Study to Assess the Effectiveness of Loha Gudhadi Gutika on Hemoglobin in Iron Deficiency Anemia in Adolescent Girls. |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Evaluation Of Loha Gudhadi Gutika In Iron Deficiency Anemia w.s.r. to Panduroga in Adolescent Girls |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sonia Madhukar Sawant |
| Designation |
Assistant Professor |
| Affiliation |
Maharashtra University Of Health Sciences, Nashik |
| Address |
Department Of Kaumarbhritya,
Ayurvidya Prasarak Mandals Ayurved Mahavidyalaya and Seth R. V Ayurved Hospital.
Near Sion Railway Station,
Sion, Mumbai
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9869262410 |
| Fax |
|
| Email |
drsoniasawant3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhavi Sanjay Deodas |
| Designation |
Professor and Head of the Department |
| Affiliation |
Maharashtra University Of Health Sciences, Nashik |
| Address |
Department Of Kaumarbhritya,
Pune District Education Association College of Ayurved and Research Centre,
Sector NO.27, Pradhikaran, Nigdi,Pune.
Pune
MAHARASHTRA
411044
India |
| Phone |
9423010818 |
| Fax |
|
| Email |
drdeodasms@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonia Madhukar Sawant |
| Designation |
Assistant Professor |
| Affiliation |
Maharashtra University Of Health Sciences, Nashik |
| Address |
Department of Kaumarbhritya,
Ayurvidya Prasarak Mandals Ayurved Mahavidyalaya and Seth R.V Ayurved Hospital,
Near Sion Railway Station,
Sion,Mumbai
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9869262410 |
| Fax |
|
| Email |
drsoniasawant3@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Kaumarbhritya,
Ayurvidya Prasarak Mandals Ayurved Mahavidyalaya and Seth R.V Ayurved Hospital,
Sion, Mumbai- 400022 |
|
|
Primary Sponsor
|
| Name |
Dr Sonia Madhukar Sawant |
| Address |
Department Of Kaumarbhritya,
Ayurvidya Prasarak Mandals Ayurved Mahavidyalaya and Seth R.V Ayurved Hospital,
Near Sion Railway Station
Sion,Mumbai-400022
|
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Madhavi Sanjay Deodas |
Department Of Kaumarbhritya,
Pune District Education Association College Of Ayurved and Research Centre.
Sector No.27,Pradhikaran, Nigdi,Pune-411044 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sonia Madhukar Sawant |
Ayurvidya Prasarak Mandals Ayurved Mahavidyalaya and Seth R.V. Ayurved Hospital |
O.P.D No.2, Ground floor and Department Of Kaumarbhritya, 3rd floor.
Near Sion Railway Station,
Sion, Mumbai - 400022
Mumbai
MAHARASHTRA |
9869262410
drsoniasawant3@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Dr.G.D.Pol Foundations YMT Ayurvedic Medical college & hospital , Kharghar, Navi Mumbai ,410210 |
Approved |
| PDEA College Of Ayurved and Research Centre , Nigdi,Pune affiliated to Maharashtra University of Health Sciences, Nashik |
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 | Classical | | (1) Medicine Name: Loha Gudhadi Gutika , Reference: Sahasrayogam, Panduroga Chikitsa, Gutika Prakaran, Shlok No.13, Page no. 321, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Udashwit), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Control Drug Ferrous Sulfate | Tablet Ferrous Sulfate 300mg 60mgFe oral route
one tablet OD 2 hours after meal with water for 90 days |
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Female |
| Details |
1)Patients with clinical Features of iron deficiency anemia only
2)Patients with Classical sign and symptoms of Panduroga described in Ayurveda texts Vivarnata ( Pallor) Panduta (severe Pallor) shunakshikuta shotha( Peri orbital edema) Hritspandan ( Palpitations) Daurbalya(weakness) Shrama ( Fatigue) Aruchi(Anorexia) Kopan(Irritability) Shwasa(Dyspnea) Pindikodweshtan(Myalgia)
3)Minimum four or more sign and symptoms as per classics will be included in the study
4)Patients whose parents are willing to give consent for clinical study |
|
| ExclusionCriteria |
| Details |
1) Hemoglobin Level lesser than 8gm Percent
2) Patient with iron therapy within 15 days prior to the screening
3) Patient with known cases of Hemoglobinopathies and blood disorders
4) Patient suffering from Anemia due to severe Blood Loss
5) Patient with Known case of Genetic disorder Congenital disease and Autoimmune Disorder malignancy cardiovascular disease hepatic and renal dysfunction Pulmonary disease gastrointestinal pathology any major systemic illness necessitating long term treatment
6) History of hypersensitivity to oral iron therapy or any Drug allergy |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Study the Effect of Loha Gudhadi Gutika on Hemoglobin gm percent in iron Deficiency Anemia ( Panduroga) in Adolescent Girls |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the tolerance and safety of Loha Gudhadi Gutika in iron Deficiency anemia in Adolescent Girls |
90 days |
| To compare the Effectiveness of Loha Gudhadi Gutika and Tablet Ferrous sulfate in iron Deficiency Anemia ( Panduroga) in Adolescent girls |
90 days |
|
|
Target Sample Size
|
Total Sample Size="170"
Sample Size from India="170"
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 |
|
Date of First Enrollment (India)
|
27/06/2025 |
| 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="3"
Days="15" |
|
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drsoniasawant3@gmail.com].
- For how long will this data be available start date provided 27-08-2026 and end date provided 27-08-2031?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This clinical study is prospective, open label, randomized , active control , parallel group study to evaluate the effect of Loha Gudhadi Gutika at the dose of 250 mg BID daily with Udashwit After meals for 90 days on hemoglobin gm percent in Adolescent girls age group 10 years to 16 years with clinical signs of iron deficiency anemia and classical sign and symptoms of Panduroga at Kaumarbhritya Department of Ayurved Institute and Hospital , Maharashtra , India . The Primary outcome measures hemoglobin gm percent on 90 days . The secondary outcome will be to determine the tolerance and safety of Loha Gudhadi Gutika in iron deficiency anemia in adolescent girls and compare the effectiveness of Loha Gudhadi Gutika and Tablet ferrous sulfate at the dose of 60mgFe OD daily , two hours after meals with water for 90 days in Iron deficiency anemia ( Panduroga).
|