CTRI Number |
CTRI/2025/06/089656 [Registered on: 26/06/2025] Trial Registered Prospectively |
Last Modified On: |
25/06/2025 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Ayurveda |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Effect of Shigru Fala Churna and Yashtimadhu Churna in Pandu (Anemia) |
Scientific Title of Study
|
ETIOPATHOLOGICAL STUDY OF PANDU ROGA W.S.R. TO ANEMIA AND COMPARATIVE THERAPEUTICAL EFFECT OF SHIGRU FALA CHURNA AND YASHTIMADHU CHURNA |
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 Rajni Thalore |
Designation |
MD Scholar |
Affiliation |
Madan Mohan Malviya Government Ayurved College |
Address |
PG Department Of Rog Nidan Evum Vikriti Vigyan Madan Mohan Malviya Government Ayurved College Radaji Choraha Udaipur PG Department Of Rog Nidan Evum Vikriti Vigyan Madan Mohan Malviya Government Ayurved College Radaji Choraha Udaipur Udaipur RAJASTHAN 313001 India |
Phone |
7014860477 |
Fax |
|
Email |
rajnithalore6901@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Pankaj Marolia |
Designation |
Professor & HOD |
Affiliation |
Madan Mohan Malviya Government Ayurved College |
Address |
PG Department Of Rog Nidan Evum Vikriti Vigyan Madan Mohan Malviya Government Ayurved College Radaji Choraha Udaipur PG Department Of Rog Nidan Evum Vikriti Vigyan Madan Mohan Malviya Government Ayurved College Radaji Choraha Udaipur Udaipur RAJASTHAN 313001 India |
Phone |
9413193101 |
Fax |
|
Email |
pankajmarolia@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Pankaj Marolia |
Designation |
Professor & HOD |
Affiliation |
Madan Mohan Malviya Government Ayurved College |
Address |
PG Department Of Rog Nidan Evum Vikriti Vigyan Madan Mohan Malviya Government Ayurved College Radaji Choraha Udaipur PG Department Of Rog Nidan Evum Vikriti Vigyan Madan Mohan Malviya Government Ayurved College Radaji Choraha Udaipur Udaipur RAJASTHAN 313001 India |
Phone |
9413193101 |
Fax |
|
Email |
pankajmarolia@gmail.com |
|
Source of Monetary or Material Support
|
Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan 313001 India |
|
Primary Sponsor
|
Name |
Madan Mohan Malviya Government Ayurved College |
Address |
Madan Mohan Malviya Government Ayurved College Radaji Circle Udaipur Rajasthan 313001 |
Type of Sponsor |
Government medical college |
|
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 Rajni Thalore |
Madan Mohan Malviya Government Ayurved College Udaipur |
OPD 4 Madan Mohan Malviya Government Ayurved College Hospital Radaji Circle Ambamata Udaipur Udaipur RAJASTHAN |
7014860477
rajnithalore@6901gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee M.M.M. Govt. Ayurved College |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:D50||Iron deficiency anemia. Ayurveda Condition: PANDUROGAH, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: SHIGRUFALA CHURNA, Reference: Susruta Uttara Tantra 44/29, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Lukewarm water), Additional Information: - | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: YASHTIMADHUCHURNA, Reference: Susruta Uttara Tantra 44/23, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, 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 |
1 Patients having clinical sign and symptoms of pandu roga.
2 The patient having Hb levels less than 12 g/dl in women and less than 13 g/dl in men . |
|
ExclusionCriteria |
Details |
1 patients suffering from AIDS,Tuberculosis,severe illness,Diabetes mellitus and other disorders of Pregnant Women.
2 Patient age below 18 yrs To above 60 yrs.
3 patient having Hb percentage below 7g/dl. |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
An Open list of random numbers |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Improvement in sign and symptoms of Pandu (Anemia) |
15 days 30 days |
|
Secondary Outcome
|
Outcome |
TimePoints |
Improvement in sign and symptoms of Pandu (Anemia) |
15th day 30th day |
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
19/07/2025 |
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="0" Months="1" Days="0" |
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
|
This is a clinical study to compare therapeutical effect of SHIGRU FALA CHURNA and YASHTIMADHU CHURNA on PANDU ROGA [ANEMIA]. In this study 2 groups each of 30 patients will be selected . Group A will be administered with Shigru Fala Churna 3gm twice a day with lukewarm water . Group B will be administered with Yashtimadhu Churna 3gm twice a day with Madhu . |