| CTRI Number |
CTRI/2024/10/075582 [Registered on: 21/10/2024] Trial Registered Prospectively |
| Last Modified On: |
19/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of Gudadi mandur vati will be check on iron deficiency anemia in pregnancy patients |
|
Scientific Title of Study
|
Randomized controlled clinical trial to evaluate the efficacy of Gudadi mandur in the management of garbhini pandu (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 Rutuja Ramchandra Yamgar |
| Designation |
PG Scholar |
| Affiliation |
C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431001 |
| Address |
OPD No 19 Prasuti Tantra and Streeroga Department C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
9922765463 |
| Fax |
|
| Email |
rutuja20yamgar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayashri Shrikant Deshmukh |
| Designation |
Professor |
| Affiliation |
C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431001 |
| Address |
OPD No 19 Prasuti tantra and Streeroga Department C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra 431011
Maharashtra. 431011
India
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
9325580777 |
| Fax |
|
| Email |
dr.jayashrisdeshmukh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rutuja Ramchandra Yamgar |
| Designation |
PG Scholar |
| Affiliation |
C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Aurangabad Maharashtra India 431001 |
| Address |
C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
9922765463 |
| Fax |
|
| Email |
rutuja20yamgar@gmail.com |
|
|
Source of Monetary or Material Support
|
| C.S.M.S.S. Ayurved Mahavidyalaya And Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431001 |
|
|
Primary Sponsor
|
| Name |
C.S.M.S.S. Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431001 |
| Address |
C.S.M.S.S. Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431001 |
| Type of Sponsor |
Private 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 Rutuja Ramchandra Yamgar |
C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi |
OPD No.19 Prasuti tantra and Streeroga Department C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad
Aurangabad
MAHARASHTRA |
9922765463
rutuja20yamgar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CSMSS Ayurved Mahavidyalaya and Rugnalaya, Aurangabad |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O990||Anemia complicating pregnancy, childbirth and the puerperium. Ayurveda Condition: PANDUROGAH, (2) ICD-10 Condition:O269||Pregnancy related conditions, unspecified. Ayurveda Condition: GARBINIROGAH, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Dhatri lauha, Reference: Sharangdhar Samhita, Madhyam Khand, shlok no 7/2, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Gudadi Mandur , Reference: Bharat Bhaishajya Ratnakar, Dvitiya bhag, Gutikaprakranam, Page no 35/1310, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Koshna Jal), Additional Information: - |
|
|
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Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.Diagnosed Patients Of Garbhini Pandu
2.Pregnant Women Of 21 TO 40 Years Age.
3. Patients In Between 14 Weeks To 30 Weeks Of Preganancy.
4. Hb% Above 7gm% And Below 10 gm%. |
|
| ExclusionCriteria |
| Details |
1. Patients Suffering From Severe Aenemia Hb Below 7 gm %.
2. Age Of Garbhini Below 21 Years And Above 40 Years.
3. Anemia Due To Major Disease , Known Case Of Thalassemia, Sickle Cell Anemia, Pernicious Anemia, Aplastic Anemia And Other Complications Like Bleeding Piles And Twin Pregnancy.
4.Any Other Obstetric Complication Like Pre-Eclampsia, Gestational Diabetes.
5. Patients With HbsAg , HIV, VDRL Positive.
6. Any Major Diseases that Interfere With The Corse Of Treatment. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| Hb % will increase |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Lakshanas of garbhini pandu will dicrease. |
2 months |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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)
|
04/11/2024 |
| 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
|
Women are roota of progeny. Anemia is most commonest haematological disorder of pregnancy. During Garbhini Avastha increased fetal demands and improper functioning of Rasadhatu leads to Garbhini Pandu. Mother will not meet the extra demands of nutrients by diet alone. This lead to certain pathological condition in pregnant women. In addition, there is marked demand of extra iron during pregnancy specially in second half of pregnancy, even an adequate diet cannot provide the extra demand of iron. Thus, there is always remains a physiological iron deficiency state during pregnancy. The general principle of treatment that all the disease of pregnant women should be treated by drugs and diet which are predominantly Mrudu ( soft), Madhur ( sweet), Sheeta ( cold), Sukhakar( palatable) . All the diseases should be treated by Sanshaman Chikitsa. Gudadi Mandur is one of such drug. Shunthi is Deepak, pachak and Raktashodhak. Pippali is Vrushya and Raktavardhak. Tila is Agnivardhak and Stanyajanak. Guda is Raktashodhak. Mandur Bhasma is considered as Raktavardhak. Study will be conducted on 92 diagnosed patients of Garbhini Pandu ( Iron Deficiency Anemia in Pregnancy) . written consent will be taken. Initial assessment will be done. patients treated with Gudadi Mandur in interventional group and with Dhatri Lauha in control group.patient will be assessed at follow up. Observation and result will be noted and statistical analysis will be done. Discussion and conclusion will be done.
- Null hypothesis (Ho) - Gudadi Mandur is not effective in the management of Garbhini Pandu ( Anemia in Pregnancy)
- Alternate hypothesis ( H1)- Gudadi Mandur is effective in the management of Garbhini Pandu ( Anemia in Pregnancy)
|