| CTRI Number |
CTRI/2024/10/075207 [Registered on: 14/10/2024] Trial Registered Prospectively |
| Last Modified On: |
26/09/2024 |
| 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 COMPARATIVE CLINICAL TRIAL TO EVALUATE THE EFFICACY OF LAUHADI CHURNA AND KASISA BHASMA IN THE MANAGEMENT OF PANDU WITH SPECIAL REFERENCE TO IRON DEFICIENCY ANAEMIA |
|
Scientific Title of Study
|
A RANDOMIZED COMPARATIVE CLINICAL TRIAL TO EVALUATE THE EFFICACY OF LAUHADI CHURNA AND KASISA BHASMA IN THE MANAGEMENT OF PANDU WITH SPECIAL REFERENCE TO 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 |
Anamika Yadav |
| Designation |
MD Scholar |
| Affiliation |
Kunwar Shekhar Vijendra Ayurved Medical College and Research Centre |
| Address |
Kayachikitsa Department
Kayachikitsa Department
Saharanpur
UTTAR PRADESH
247341
India |
| Phone |
6392291564 |
| Fax |
|
| Email |
anamikadrydv95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr ANAND PRATAP SINGH |
| Designation |
HOD DEPARTMENT OF KAYACHIKITSA |
| Affiliation |
Kunwar Shekhar Vijendra Ayurved Medical College And Research Centre |
| Address |
Kunwar Shekhar Vijendra Ayurved Medical College and Research Centre Gangoh Saharanpur
Saharanpur
UTTAR PRADESH
247341
India |
| Phone |
8840749954 |
| Fax |
|
| Email |
apsingh11264@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr ANAND PRATAP SINGH |
| Designation |
HOD DEPARTMENT OF KAYACHIKITSA |
| Affiliation |
Kunwar Shekhar Vijendra Ayurved Medical College And Research Centre |
| Address |
Kunwar Shekhar Vijendra Ayurved Medical College and Research Centre Gangoh Saharanpur
Saharanpur
UTTAR PRADESH
247341
India |
| Phone |
8840749954 |
| Fax |
|
| Email |
apsingh11264@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kunwar Shekhar Vijendra Ayurved Medical College and Research Centre Gangoh, Saharanpur -247341 |
|
|
Primary Sponsor
|
| Name |
DrAnamika Yadav |
| Address |
Kunwar Shekhar Vijendra Ayurved Medical College and Research Centre Gangoh Saharanpur -247341 |
| 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 Anamika Yadav |
Kunwar Shekhar Vijendra Ayurved Medical College and Research Centre Gangoh Saharanpur 247341 |
OPD & IPD of kayachikitsa Department, Kunwar Shekhar Vijendra Ayurved Medical College and Research Centre Gangoh Saharanpur 247341
Saharanpur
UTTAR PRADESH |
6392291564
anamikadrydv95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kunwar Shekhar Vijendra Ayurveda Medical College & Research Centre,Gangoh Saharanpur |
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: Lauhadi Churna, Reference: Vaidya chintamani Bhesajottam Grantha A great treatise of best recipes by Shri Vallabhacarya chapter 6 slok 144 written by proff k Rama Chandra Reddy page no 301, Route: Oral, Dosage Form: Churna/ Powder, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 75 Days, anupAna/sahapAna: Yes(details: -Takra), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kasisa Bhasma, Reference: Rasatarangini pranacharya Shrisdanandsharmana virchita writteb by Pandit kashinath shastri chapter 21 Page no 565 Slok 231 and 232 published by Motilal Banarsi Das Publication, Route: Oral, Dosage Form: Churna/ Powder, Dose: 125(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 75 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 of either sex with age above 18 years to 60 years
2 Patient present with classical sign and symptoms of Pandu
3 Patient present with sign and symptoms of iron deficiency anaemia
4 Patient having Hb in the range of 7-10 gm/dl
5 Serum iron content less then 50ug /L
6 TIBC in the range of more than 350ug/dl
7 Microcytic hypochromic anaemia i.e. MCHC less then 34 gm per dl and MCV less then 80 fL
8 Only those patients having Pandu as an independent disease & not as upadrava
9 Patient willing to give informed consent to participate in trial
|
|
| ExclusionCriteria |
| Details |
1. Patient with severe Anaemia or congenital anaemia.
2. Patient present with co- morbid disorder (D.M, T.B, R.A etc.)
3. Patient with poorly controlled hypertension.
4. Patient with concurrent serious hepatic disorders or renal disorders or any other systemic / serious complication like cerebrovascular / cardiovascular disease that may jeopardize the study.
5. H/o Hypersensitivity to the trial drug or any of its ingredients.
6. Patient had completed participation in any other clinical trial in past 6 months.
7. Pregnant or lactating women.
8. Patients having Kamla, Rakta-Pradara, Rakta-Pitta, Raktarsha, Raktasrava
9. Age below 18 years
10. SGOT level more than 40 unit/lit.
11. SGPT level more than 6 unit/lit.
12. S.creatinine level more than 1.5 mg/dl .
13. S.Urea level more than 30 mg/dl
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in Sign and Symptoms of Pandu with in 12 weeks |
Reduction in Sign and Symptoms of Pandu with in 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 To Observe adverse adverse effects if any
2 Cost effective treatment |
75 Days |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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 3 |
|
Date of First Enrollment (India)
|
25/10/2024 |
| 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
|
The volunteers will be informed about the study protocol.Willing participants will be randomly selected as per computer generated table.The clinical reserch format will be prepared and validated. Prior to the study, approval will be taken from IEC, KSVAMC & RC, SU GANGOH, SAHARANPUR and CTRI registration will be done after selection,each participant will be tested individually and selected criteria. They are divided into two groups is a single centre, open label, Randomised, Interventional,Comparative Clinical Study.
|