| CTRI Number |
CTRI/2025/05/086142 [Registered on: 02/05/2025] Trial Registered Prospectively |
| Last Modified On: |
24/04/2025 |
| 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
|
Medicated tablet for iron deficiency Anemia |
|
Scientific Title of Study
|
A RANDOMIZED CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF BHUNIMBADI GUTIKA IN THE MANAGEMENT OF PANDUROGA IRON DEFICIENCY ANAEMIA |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrShwetarani |
| Designation |
PG scholar |
| Affiliation |
Alvas Ayurveda Medical College and Hospital vidyagiri Moodubidire Dakshin Kannada Karnataka 574227 |
| Address |
PG department of kayachikitsa 3rd floor Alvas Ayurveda Medical College and Hospital vidyagiri Moodubidire Dakshin Kannada Karnataka 574227
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9902122311 |
| Fax |
|
| Email |
shwetaranic122@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Surekha Pai |
| Designation |
Professor |
| Affiliation |
Alvas Ayurveda Medical College and Hospital vidyagiri Moodubidire Dakshin Kannada Karnataka 574227 |
| Address |
Department of Kayachikitsa 3rd floor Alvas Ayurveda Medical College and Hospital vidyagiri Moodubidire Dakshina Kannada Karnataka 574227
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
8921385332 |
| Fax |
|
| Email |
mdalvasayu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrShwetarani |
| Designation |
Pg scholar |
| Affiliation |
Alvas Ayurveda Medical College and Hospital vidyagiri Moodubidire Dakshin Kannada Karnataka 574227 |
| Address |
Department of Kayachikitsa 3rd floor Alvas Ayurveda Medical College and Hospital vidyagiri Moodubidire Dakshin Kannada Karnataka 574227
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9902122311 |
| Fax |
|
| Email |
shwetaranic122@gmail.com |
|
|
Source of Monetary or Material Support
|
| Alvas Ayurveda Medical College and Hospital vidyagiri Moodubidire Dakshin Kannada Karnataka 574227 |
|
|
Primary Sponsor
|
| Name |
Dr Shwetarani |
| Address |
Alvas Ayurveda Medical College and Hospital vidyagiri Moodubidire Dakshin Kannada Karnataka 574227 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shwetarani |
Alvas Ayurveda Medical College and Hospital |
PG department of Kayachikitsa 3rd floor
Dakshina Kannada
KARNATAKA |
9902122311
shwetaranic122@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Alvas Ayurveda Medical College |
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: Bhunimbadi Gutika, Reference: Bhruhat Nigantu Ratnakar , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -madhu), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Datri Loha, Reference: Bhaisajya Ratnavali , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients who will give written consent.
patients who fulfill the diagnostic criteria. Patients in the age group between 18 to 60 years |
|
| ExclusionCriteria |
| Details |
1.Patient having Severe Anaemia less than 8
2.Patient having haematological disorders like Sickle Cell Anaemia ,Thalassemia.
3.Patient suffering from chronic disorder like Rheumatoid Arthritis, Chronic kidney diseases, IHD.
4.Patient suffering from any continuing blood loss eg- Hematemesis, Melena, Bleeding piles.
5.Patient having gynecological problems like Menorrhagia, Metrorrhagia.
6.Patient who are on vitamin and iron supplements
7.Pregnant and Lactating mother. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Panduta(pallor)
Arohana Ayasa(tired while climbing) |
46 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Shrama (Fatigue)
Hridayaspandan (Palpitation)
Pindikodveshthana(Cramps in calf region)
Aruchi (Anorexia ) |
46 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
10/05/2025 |
| 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="6"
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 - NO
|
|
Brief Summary
|
AIM OF THE STUDY To evaluate the efficacy of Bhunimbadi Gutika in the management of Panduroga Iron deficiency Anaemia.
OBJECTIVE OF STUDY To evaluate the efficacy of Bhunimbadi Gutika in the management of Panduroga. To compare the efficacy of Bhunimbadi Gutika and Dhatri Loha in Panduroga.
HYPOTHESIS: Ho - There is neither statistically significant difference between the effect of Bhunimbadi Gutika and Dhatri Loha nor Bhunimbadi Gutika is better than Dhatri Loha in the Management of Panduroga. H1 -There is a statistically significant difference in the effect of Bhunimbadi Gutika and Dhatri loha with Bhunimbadi Gutika having a better effect than Dhatri Loha in the Management of Panduroga.
|