| CTRI Number |
CTRI/2024/09/073359 [Registered on: 04/09/2024] Trial Registered Prospectively |
| Last Modified On: |
14/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Observation of symptoms of Anemia |
|
Scientific Title of Study
|
Association of Pandu Lakshanas With Haemogram An Observational 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 Deepika G S |
| Designation |
PG Scholar |
| Affiliation |
KAHERs Shri B M Kankanawadi Ayurveda Hospital and research |
| Address |
Department of Roga Nidana
KAHERs Shri B M Kankanawadi Ayurveda Hospital and Research Centre Shahapur Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
9663984787 |
| Fax |
|
| Email |
deepikags08091998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Keertan M S |
| Designation |
Associate Professor |
| Affiliation |
KAHERs Shri B M Kankanawadi Ayurveda Hospital and Research centre |
| Address |
Department of Roga Nidana
KAHERs Shri B M Kankanawadi Ayurveda Hospital and Research Centre Shahapur Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
9886238888 |
| Fax |
|
| Email |
keertanms@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Keertan M S |
| Designation |
Associate Professor |
| Affiliation |
KAHERs Shri B M Kankanawadi Ayurveda Hospital and Research centre |
| Address |
Department of Roga Nidana
KAHERs Shri B M Kankanawadi Ayurveda Hospital and Research Centre Shahapur Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
9886238888 |
| Fax |
|
| Email |
keertanms@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHERs Shri B M Kankanwadi Ayurveda Hospital and Research Centre |
|
|
Primary Sponsor
|
| Name |
Dr Deepika G S |
| Address |
Department of Roga Nidana KAHERs Shri B M Kankanwadi Ayurveda Hospital and Research Centre Shahapur Belagavi 590003 Karnataka India |
| 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 Deepika G S |
KAHERs Shri B M Kankanawadi Ayurveda Hospital and Research Centre |
Room number 04
Department of Roganidana
Belgaum
KARNATAKA |
9663984787
deepikags08091998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe For Research on Human Subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:D899||Disorder involving the immune mechanism, unspecified. Ayurveda Condition: PANDUROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients of either gender within the age group of 18 to 60 years
2 Provide informed consent for involvement in research activities |
|
| ExclusionCriteria |
| Details |
1 Person who are regularly travelling from village to city and vice versa
2 Person who have undergone recent major surgeries or blood loss in 3 months
3 K/C/O Sideroblastic anemia, Sickle cell anemia, Thalassemia, Leukemia, bleeding disorders
4 Pregnancy and Lactating women
5 Systemic infective disorders like severe sepsis, Tuberculosis |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Low digestion or destructed digestive power
2. Weakness
3. Less activity
4. Fatigue
5. Giddiness
6. Pain in the body
7. Heaviness
8. Anorexia
9. Limbs are being kneaded, pressed or churned
10. Person loses his body Prabha (luster)
11. Irritable
12. Dislikes towards cold things.
13. Specifically exertion while climbing
|
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Tinnitus
2. Reduced holding of Anna (for digestion and absorption)
3. Fever
4. Dysponea
5. Develops orbital region swelling
6. Falling of body hair
7. Feels sleepy
8. Spits in excess
9. He avoids speaking
10. Suffers from cramps in the calf region
11. Experiences of excessive pain and weakness in the lumbar region thighs and feet.
12. Hemogram
13. Peripheral smear |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
01/01/2025 |
| 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="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
|
Pandu is varnopalakshita vyadhi chiefly characterized by pallor, loss of luster and deterioration of general health. Pandu is one among the major diseases of the modern era with continuously changing lifestyles, environments, and dietary habits.
Air quality tends to be better in rural areas compared to urban areas due to urbanization, industrial activities, concentration of vehicles. Rural areas have cleaner air due to less traffic and industrial activity additionally rural areas often have more green spaces and vegetation. Exposures to air pollutants affects bone marrow stimulation, downs regulation of erythropoietin production which can lead to diminished haemoglobin.
The World Health Organization global estimates of anemia prevalence averaged 56%, with a range of 35%-75% depending on geographic location. According to NFHS4 Prevalence of anaemia is 13.5% in men and 41.2% in women.
There are lot of researches shown that Hb level is varied in urban and rural population, Hence an effort is made here to assess the Lakshanas of Pandu with Hemogram. |