| CTRI Number |
CTRI/2025/02/081094 [Registered on: 21/02/2025] Trial Registered Prospectively |
| Last Modified On: |
14/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Management of pandu(iron deficiency anaemia) in college going girls through panchasara panaka syrup |
|
Scientific Title of Study
|
Randomized Control Trial To Evaluate The Physiological Effect Of Panchasara Panaka Syrup In Pandu Roga With Special Reference To Iron Deficiency Anaemia In College Going Girls |
| 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 Priyanka |
| Designation |
MD Scholar |
| Affiliation |
Madan Mohan Malviya Government Ayurved College |
| Address |
PG Department Of Kriya Sharir Madan Mohan Malviya Government Ayurved College Radaji Choraha Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
7986072062 |
| Fax |
|
| Email |
priyakamboj538@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kishori Lal Sharma |
| Designation |
Associate Professor |
| Affiliation |
Madan Mohan Malviya Government Ayurved College |
| Address |
PG Department Of Kriya Sharir Madan Mohan Malviya Government Ayurved College Radaji Choraha Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
9414702671 |
| Fax |
|
| Email |
drklalsharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kishori Lal Sharma |
| Designation |
Associate Professor |
| Affiliation |
Madan Mohan Malviya Government Ayurved College |
| Address |
PG Department Of Kriya Sharir Madan Mohan Malviya Government Ayurved College Radaji Choraha Udaipur
RAJASTHAN
313001
India |
| Phone |
9414702671 |
| Fax |
|
| Email |
drklalsharma@gmail.com |
|
|
Source of Monetary or Material Support
|
| Madan Mohan Malviya Government Ayurved College Radaji Choraha Udaipur |
|
|
Primary Sponsor
|
| Name |
Madan Mohan Malviya Government Ayurved College |
| Address |
PG Department Of Kriya Sharir Madan Mohan Malviya Government Ayurved College Radaji Choraha Udaipur Rajasthan India 313001 |
| 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 Priyanka |
Government Ayurved Hospital |
OPD Room no 1 Motichohtta Udaipur Rajasthan India 313001
Udaipur
RAJASTHAN |
7986072062
priyakamboj538@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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: Panchasara Panaka, Reference: Madanpal Nighantu, Route: Oral, Dosage Form: Panak/ Sharbat, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Placebo Lemon Squash, Reference: NA, Route: Oral, Dosage Form: Panak/ Sharbat, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
Volunteers of age group 18 to 30 years will be taken
Volunteers of Female gender will be taken
Subjects with Iron Deficiency Anaemia Hemoglobin 7 gm percent to 11.9 gm percent
Subjects who are willing to give consent for clinical trial
|
|
| ExclusionCriteria |
| Details |
Age below 18 and above 30 years person
Pregnant and lactating women
Person who are suffering from systematic diseases and necessitating long term treatment
Subjects with severe Iron Deficiency Anaemia Hemoglobin Less than 7 gm percent
Subjects with concurrent serious hepatic dysfunction or renal dysfunction and uncontrolled pulmonary dysfunction
Comorbidity like Tuberculosis Urinary tract infection and bleeding disorders
History of hypersensitivity to any of the trial drug or their ingredients
Subjects who have completed participation in any other clinical trial during the past six months
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Evaluate the Physiological Effect of Panchasara Panaka Syrup in Pandu with special reference to Iron Deficiency Anaemia. |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To review the literature related to Pandu.
2. To review the literature related to Iron Deficiency Anaemia as per modern text.
3. To correlate the relationship between Pandu and Iron Deficiency Anaemia.
|
60 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
21/07/2025 |
| 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="7"
Days="15" |
|
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
|
This study the 60 clinically diagnosed patients of Pandu/Anaemia Subjects are divided into 2 group; Group- A: experimental
group 30 subjects Group- B: control group - 30 subjects This study Aims to Evaluate
the Physiological Effect of Panchsara Panaka Syrup in Pandu Roga
with special reference to Iron Deficiency Anaemia in College going girls. |