| CTRI Number |
CTRI/2024/07/071178 [Registered on: 23/07/2024] Trial Registered Prospectively |
| Last Modified On: |
04/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to know effect of hutabhugadi churna in patients of low heamoglobin percentage |
|
Scientific Title of Study
|
A Clinical study to evaluate the efficacy of Hutabhugadi churna in the management of Pandu roga(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 |
Ch Polika Naga Krishna sai |
| Designation |
PG scholar department of kayachikitsa |
| Affiliation |
Dr.Achanta lakshmipathi government ayurvedic hospital , vijayawada |
| Address |
Dr N R S GOVERNMENT AYURVEDIC COLLEGE
MG ROAD
VIJAYAWADA
Department of kayachikitsa Room no-5
Krishna
ANDHRA PRADESH
520002
India |
| Phone |
8746901365 |
| Fax |
|
| Email |
Polika0307@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.P sai sudhakar |
| Designation |
Principal Dr.NRSGAC, HOD and professor dept of kayachikitsa |
| Affiliation |
Dr.Achanta lakshmipathi ayurvedic hospital |
| Address |
Dr.NRS Government ayurvedic college
MG road
Vijayawada
Department of kayachikitsa
Room no 5
Krishna
ANDHRA PRADESH
520002
India |
| Phone |
9849331607 |
| Fax |
|
| Email |
sudhimd_padamata@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Ch Polika Naga Krishna sai |
| Designation |
Pg scholar |
| Affiliation |
Dr.Achanta lakshmipathi ayurvedic hospital |
| Address |
Dr.NRS Government ayurvedic college
Department of kayachikitsa
Department of kayachikitsa
Room no 5
Krishna
ANDHRA PRADESH
520002
India |
| Phone |
8746901365 |
| Fax |
|
| Email |
Polika0307@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.Achanta lakshipathi hospital, Vijayawada-520002 |
|
|
Primary Sponsor
|
| Name |
Ch Polika Naga Krishna sai |
| Address |
1/396-4 Bharadwaja Nilayam Lakkaraju vari veedhi Chintaguntapalem Machilipatanam Krishna district Andhra pradesh 52100 |
| 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 Ch Polika |
Dr.Achanta lakshmipathi hospital |
Dept of kayachikitsa
Room no 5
Krishna
ANDHRA PRADESH |
8746901365
polika0307@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
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: Hutabhugadi churna , Reference: Sahasrayogam , Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Amla udasvith(sour buttermilk)), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Pandu roga diagnosed according to subjective and objective criteria and
Mentzer index above 13 |
|
| ExclusionCriteria |
| Details |
Anaemia due to internal bleeding, external bleeding, gastric and duodenal ulcer, hemorrhoids,
pregnancy induced Anaemia, Leukemia, Major Kidney diseases like ARF, CRF and haemoglobin less than 8gm/dl and above 11gm/dl
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in signs and symptoms and significant improvement of objective parameters |
In 45 days period including assessment for every 15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in hemoglobin percentage ,pcv,mcv,mch |
Treatment period of 45days
Assessment for every 15days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
20/08/2024 |
| 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
|
A clinical trail is done to evaluate the efficacy of the ayurvedic formulation named Hutabhugadi churna in the management of pandu(iron deficiency anaemia) and to validate scientifically the observations that would significantly change the haemoglobin percentage and also relief in signs and symptoms i.e panduta, arohanayasa, agnimandhya, daurbalya, kopana.Hutabhugadi churna is an unique formulation in the management of pandu roga which has its reference from sahasrayogam churna prakarana acts by stimulating jataragni given orally 5gms twice daily with amla uadasvith (sour buttermilk) for 45 days with an assessment for every 15 days for 30 patients of age group between 15-45 years irrespective of gender diagnosed according to subjective and objective parameters and patients suffering from bleeding disorders ,major kidney disease are excluded.The study would be conducted in India aimed to complete in 18 months. Primary outcome measures will be relief in signs and symptoms(subjective parameters) and Secondary outcome will be increase in hemoglobin percentage, changes in peripheral blood smear, mcv, mch. Subjective and objective parameters will be observed before and after the treatment and result assessment is done |