| CTRI Number |
CTRI/2023/09/057530 [Registered on: 13/09/2023] Trial Registered Prospectively |
| Last Modified On: |
05/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Compare effect of darvyadi leha and loha bhasma in management of pandu vyadhi |
|
Scientific Title of Study
|
Comparative clinical trial of darvyadi leha and loha bhasma In management of pandu with special reference to iron deficiency Anemia |
| 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 Girish Hanumant Moharkar |
| Designation |
PG Scholar |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta |
| Address |
OPD no 1 Kayachikitsa OPD Ground Floor Dhanvantari Ayurved Hospital Ashta Tal Walwa Dist Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
9834331199 |
| Fax |
|
| Email |
girishmoharkar27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Smita Lokhande |
| Designation |
Associate Professor |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta |
| Address |
3rd Floor Department of Kayachikitsa Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta Tal Walwa Dist Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
8149556591 |
| Fax |
|
| Email |
yoshitpriya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Smita Lokhande |
| Designation |
Associate Professor |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta |
| Address |
3rd Floor Department of Kayachikitsa Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta Tal Walwa Dist Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
8149556591 |
| Fax |
|
| Email |
yoshitpriya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta |
|
|
Primary Sponsor
|
| Name |
Dr Girish Hanumant Moharkar |
| Address |
OPD no 1 Kayachikitsa OPD Ground Floor Dhanvantari Ayurved Hospital Ashta Tal Walwa Dist Sangli
|
| 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 Girish Hanumant Moharkar |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta |
OPD no 1 Kayachikitsa OPD Ground Floor Dhanvantari Ayurved Hospital Ashta Tal Walwa Dist Sangli
Sangli
MAHARASHTRA |
9834331199
girishmoharkar27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta 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: Darvyadi Leha, Reference: Charak Sahita, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Ghrut And Madhu Vishammatra), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Loha Bhasma, Reference: Yogaratnakar, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Ghrut And Madhu Vishammatra), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Patient Diagnosed With Pandu Roga Visiting To OPD And IPD Of Kaychikitsa
2 HB Percentage Male 7gm Per dl To 12gm Per dl
Female 7gm Per dl to 11gm Per dl |
|
| ExclusionCriteria |
| Details |
1 Age Group Below 16 And Above 60 Years
2 Anemia Associated With Other Pathology Like Cardiac Renal Diabetes Mellitus Acute And Chronic Blood Loss
3 Pregnant Woman And Lactating Woman
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Compare Effect Of Darvyadi Leha And Loha bhasma In Pandu With Special References To Iron Deficiency Anemia |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 To Evaluate The Efficacy Of Darvyadi Leha In Pandu With Special Reference To Iron Deficiency Anemia
2 To Evaluate The Efficacy Of Loha Bhasma In Pandu With Special Reference To Iron Deficiency Anemia
3 To Review The Detail About Pandu Vyadhi And Iron Deficiency Anemia
4 Untoward Effect Of Both Drug |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
30/09/2023 |
| 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
|
Iron deficiency anemia is commonest nutritional disorder. India is one of the country of highest prevalence of iron deficiency anemia. todays wrong lifestyle and food habit causes nutritional disorder. there are many Ayurvedic formulation is mention in Ayurvedic Samhita and granthas. so i’ll study about comparative efficacy of darvyadi Leha and loha bhasma in management of pandu with special reference to iron deficiency anemia for 28 days and check HB before and after treatment. |