| CTRI Number |
CTRI/2025/08/092320 [Registered on: 04/08/2025] Trial Registered Prospectively |
| Last Modified On: |
02/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use of navayas lauh(type of churna preparation)in the management of garbhini pandu (Iron deficiency anemia in pregnancy) |
|
Scientific Title of Study
|
Clinical study to evaluate the efficacy of Navayas Lauha in the management of Garbhini Pandu w.s.r to Iron deficiency Anemia in Pregnancy |
| 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 Anju Yadav |
| Designation |
MS PG Scholar |
| Affiliation |
Vaidya Yagya dutt Sharma Ayurved Mahavidyalaya |
| Address |
Room no25,26 Department of Prasutitantra evum Stree Roga Vaidya Yagyadutt Sharma Ayurved Mahavidyalaya khurja Bulandshahr
Bulandshahar
UTTAR PRADESH
203131
India |
| Phone |
8707361756 |
| Fax |
|
| Email |
anjuyadav0011@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhappil Sharma |
| Designation |
MS Ayurveda HOD Department of Prasutitantra evum Stree Roga |
| Affiliation |
Vaidya Yagya dutt sharma Ayurved Mahavidyalaya |
| Address |
Room no25,26 Department of Prasutitantra evum Stree Roga Vaidya Yagyadutt Sharma Ayurved Mahavidyalaya khurja Bulandshahr
Bulandshahar
UTTAR PRADESH
203131
India |
| Phone |
7018687930 |
| Fax |
|
| Email |
drbhapilsharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhappil Sharma |
| Designation |
MS Ayurveda HOD Department of Prasutitantra evum Stree Roga |
| Affiliation |
Vaidya Yagya dutt sharma Ayurved Mahavidyalaya |
| Address |
Room no25,26 Department of Prasutitantra evum Stree Roga Vaidya Yagyadutt Sharma Ayurved Mahavidyalaya khurja Bulandshahr
Bulandshahar
UTTAR PRADESH
203131
India |
| Phone |
7018687930 |
| Fax |
|
| Email |
drbhapilsharma@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vaidya vagyadutt sharma Ayurved Mahavidyalaya khurja Bulandshahr Uttar Pradesh 203131 |
|
|
Primary Sponsor
|
| Name |
Dr Anju Yadav |
| Address |
Room no25,26 Department of Prasutitantra evum Stree Roga Vaidya Yagyadutt Sharma Ayurved Mahavidyalaya khurja Bulandshahr |
| 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 Anju Yadav |
Vaidya Yagya dutt sharma Ayurved Mahavidyalaya Khurja Bulandshahr |
Room no25,26 Department of Prasutitantra evum Stree Roga Vaidya Yagyadutt Sharma Ayurved Mahavidyalaya khurja
Bulandshahar
UTTAR PRADESH |
8707361756
anjuyadav0011@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commiittee Vaidya vagyadutt sharma Ayurved Mahavidyalaya Khurja Bulandshahr Uttar Pradesh |
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: GARBINIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Navayas Lauh, Reference: Bhaishajya Ratnawali chapter 12 chikitsa adhyaya, Route: Oral, Dosage Form: Lauha-Mandura, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -madhu ghrita), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant woman age group 20-40 yrs
1st,2nd and 3rd trimester
Primi and multigravida both
Hb% between 7gm % to 10 gm % |
|
| ExclusionCriteria |
| Details |
Age below 20 year and above 40 year
All type of anemia other than iron deficiency Anemia
All patient in high risk pregnancy group other than iron deficiency Anemia
All major systemic disease
Hb gm % below 7gm % and above 10 gm % |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in haemoglobin parameter |
The trial drug will be given for 3 months with anupana and follow up will be done after cessation of medicine in 4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction of pallor,fatigue and loss of appetite and palpitation |
After analyzing all the parameters the result will be assessed on the basis of symptomatic relief and improvement
Partially improvement after 15 days-patient get 30percent relief from sign and symptoms
Improvement after 1 month patient get 40-50 percent relief from sign and symptoms
Improvement after 2 months patient get 60-80 percent relief from sign and symptoms
Cured after 3 months patient get 80-100 percent relief from signs and symptoms. |
|
|
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 3 |
|
Date of First Enrollment (India)
|
15/08/2025 |
| 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="10"
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
|
Due to the predominance of paleness all over the body it is named as pandu roga. The patient in whom dosas with predominance of pitta are vitiated in dhatus is affected with the Laxity of dhatus and heaviness in body .Complexion strength ,unctuousness and other properties also get too much
diminished due to morbidity of Dosa and dusya .Thus she gets affected with deficiency of blood
,fat,ojas,looseness of bodyparts and abnormality of complexion. There are several drugs for garbhini pandu but here I have chosen Navayas lauh with Madhu and ghrit as it acts as rasayan and uttam raktavridhikara. Therefore I have selected 40 patients aged between 20-40 years, Patient should be selected on the basis of inclusion and exclusion criteria. The trial will be of 3 consecutive months and follow up will be done after 15 days then after each month. Cured after 3 months patient gets 80-100 percent relie from signs and symptoms. |