| CTRI Number |
CTRI/2024/07/070162 [Registered on: 08/07/2024] Trial Registered Prospectively |
| Last Modified On: |
05/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Cross sectional study on types of anaemia in pregnancy |
|
Scientific Title of Study
|
Various types of Pandu in Garbhini - A cross sectional study. |
| 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 Prateeti Meshram |
| Designation |
PG SCHOLAR |
| Affiliation |
Pt khushilal Sharma Ayurveda Research Institute |
| Address |
Department of Roga nidana and vikrti vigyana.Pt. khushilal sharma Ayurveda College, Nehru nagar. Bhopal.
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
7049840825 |
| Fax |
|
| Email |
prateeti03@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Srivastava |
| Designation |
Professor and H.O.D, Rognidana evum vikrati vigyana department |
| Affiliation |
Pt khushilal Sharma Ayurveda Research Institute |
| Address |
Department of Rognidana OPD. Pt. khushilal sharma Ayurveda hospital, Science hills, Nehru nagar. Bhopal.
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9425012608 |
| Fax |
|
| Email |
sanjayayurvedabhopal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Srivastava |
| Designation |
Professor and H.O.D, Rognidana evum vikrati vigyana department |
| Affiliation |
Pt khushilal Sharma Ayurveda Research Institute |
| Address |
Department of Rognidana OPD, Pt. khushilal hospital, Science hills, Nehru nagar. Bhopal.
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9425012608 |
| Fax |
|
| Email |
sanjayayurvedabhopal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt. Khushilal sharma Govt. Ayurveda College. Bhopal (M.P) India
Pincode - 462003 |
|
|
Primary Sponsor
|
| Name |
Pt Khushilal sharma Government Ayurveda College and Hospital |
| Address |
Science hills behind MANIT, Kolar road, Nehru nagar. Bhopal. Madhya pradesh. India
Pincode 462003 |
| 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 PRATEETI MESHRAM |
Pt. Khushilal sharma Government Ayurveda College and hospital Bhopal |
Rognidana evum vikruti vigyan department OPD Pt. Khushilal sharma Government Ayurveda College and hospital Bhopal Science hills, Nehru nagar. Bhopal.
Pincode 462003
Bhopal
MADHYA PRADESH |
07049840825
prateeti03@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Pt. Khushilal Sharma Government Ayurveda Institute, Bhopal (M.P) |
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 |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
a) Participants who are suffering from the group of symptoms (criteria for diagnosis) will be included in the study.
b) Participants who are having haemoglobin below 11gm%.
c) Participants who are willing to sign consent forms for participating in the research study . |
|
| ExclusionCriteria |
| Details |
a) Participants who are not fulfilling the inclusion criteria.
b) Participants who are suffering from the following conditions were excluded from the study
c) Liver cirrhosis, Cardiovascular disease, Malignancy.
d) High risk pregnancies like bad obstetrics history, pregnancy-induced hypertension, and TORCH infection will be rejected.
e) Participants who are not willing to sign the consent form for participating in the research study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| we will explore the relationship between different aspects such as causative factors, pathogenesis, and clinical features of various Pandu Roga with Garbhini Pandu. |
Patient will be observed for CBC, Serum ferritin, and blood group before treatment on 0th day only |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. We may be able to identify whether there is a blood group that is more susceptible to Pandu Roga.
2. This study will help us to develop effective strategies for the prevention, diagnosis, and management of Garbhini Pandu. |
12 month |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
N/A |
|
Date of First Enrollment (India)
|
18/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
18/07/2024 |
| 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
|
CRITERIA FOR DIAGNOSIS The participants having signs and symptoms of subjective and objectives parameters will be selected considering the identical features for particular Doshaj Pandu Roga as detailed below: In Vataj Pandu Roga - Krushna and Panduvarnta of skin, eyes, urine Rukshta (Dryness of skin) Angamard ( body ache) Jwara (fever) Ruja ( pricking pain) Parshv and shirhshool(headache) Aanaha, (flatulence) Shoph (edema over body part) Varch shosh (constipation) Mukhvairashya (tastelessness) Bhramam, balkshya. In Pitta Pandu Roga - Peeto haritabho (Yellow discoloration of skin, urine, faeces) Jwar and daha (Fever and burning) Murcha and pipasa (Thirst and syncope) Bhinna varcha (Diarrhoea) Daurbalya (weakness) Aruchi (Anorexia) Amlodgar. In Kaphaj Pandu Roga - Whitish discoloration of skin, eyes, urine Gaurav, Tandra, chardi Aalasya, aruchi Swash (Dyspnea & cough) Murcha, bhramam, klama (Syncope, vertigo, malaise) Prasheka (excessive salivation) Shavathu (generalized edema) INVESTIGATION CBC Serum ferritin Blood group Criteria for selection of patients IInclusion criteria - Participants who are between the age group of 21 to 35 years female.
- Participants suffering from the above group of symptoms (criteria for diagnosis) will be included in the study
- Participants who are having haemoglobin below 11gm%.
- Participants willing to sign consent forms for participating in the research study.
Exclusion criteria - Participants who are not fulfilling the inclusion criteria.
- Participants who are suffering from the following conditions were excluded from the study -Liver cirrhosis, Cardiovascular disease, Malignancy.
- High risk pregnancies like bad obstetrics history, pregnancy-induced hypertension, and TORCH infection will be rejected.
- Participants who are unwilling to sign the consent form for participating in the research study.
|