| CTRI Number |
CTRI/2023/08/056119 [Registered on: 04/08/2023] Trial Registered Prospectively |
| Last Modified On: |
11/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Development of Precision method for Pandu |
|
Scientific Title of Study
|
Development of Precision method and its validation by assessing to effect of Punarnava (Boerhaavia diffusa Linn.) in Pandu |
| 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 Urviben Gajanandbhai Pandya |
| Designation |
M.D.Scholar 2nd year |
| Affiliation |
Govt.Ayurvedic college Vadodara |
| Address |
Post graduate department of Dravyaguna Government Ayurved
College, Ajwa road, Dhanvantari marg, Panigate
Vadodara
GUJARAT
390019
India |
| Phone |
7069059078 |
| Fax |
|
| Email |
ugpandya1737@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dilip K Jani |
| Designation |
H.O.D. and Professor |
| Affiliation |
Govt.Ayurvedic college Vadodara |
| Address |
Post graduate department of Dravyaguna Government Ayurved
College, Ajwa road, Dhanvantari marg, Panigate
Vadodara
GUJARAT
390019
India |
| Phone |
9925941861 |
| Fax |
|
| Email |
drdilipjn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suman Singh |
| Designation |
Assistant Professor |
| Affiliation |
Govt.Ayurvedic college Vadodara |
| Address |
Post graduate department of Dravyaguna Government Ayurved
College, Ajwa road, Dhanvantari marg, Panigate
Vadodara
GUJARAT
390019
India |
| Phone |
9510172204 |
| Fax |
|
| Email |
snghsmn@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurved College and Hospital,Ajwa road, Dhanvantari marg, Panigate,
Vadodara-390019 |
|
|
Primary Sponsor
|
| Name |
Government Ayurved Hospital Vadodara |
| Address |
Goverment Ayurved Hospital, Ajwa road, Dhanvantari marg,
Panigate,Vadodara-390019
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Urviben Gajanandbhai Pandya |
Government Ayurved Hospital, Vadodara |
OPD and IPD,
Dravyaguna
Department Vadodara
GUJARAT
Vadodara
GUJARAT
Vadodara
GUJARAT |
7069059078
ugpandya1737@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUYIONAL ETHICS COMMITTEE,Goverment Ayurveda college and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:R688||Other general symptoms and signs. Ayurveda Condition: PANDUROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: PUNARNAVA, Reference: Bhavprakash Nighantu, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Weeks, anupAna/sahapAna: Yes(details: Ghrita), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: PUNARNAVA, Reference: Bhavprakash Nighantu , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Weeks, anupAna/sahapAna: No, Additional Information: - | | 3 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Punarnava, Reference: Bhavprakash, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Weeks, anupAna/sahapAna: No, Additional Information: - | | 4 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Punarnava, Reference: Bhavprakash, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Weeks, anupAna/sahapAna: Yes(details: Madhu(Honey)), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
symptoms of Pandu: Panduta(Paleness)
Hridaspandana(Palpitation), Daurbalya(Weakness)
Group A: Vata dominant symptoms Pindikodwestana (cramps in the calf muscle), Rukshata (Dryness of skin), Angamarda (Body ache), Kampa (Trembling)
Group B: Kapha dominant symptoms Gaurava (Heaviness), Bhrama (Vertigo), Klama (Mental fatigue), Aalasya (Laziness), Aruchi (Anorexia)
|
|
| ExclusionCriteria |
| Details |
1. Age <20 to > 30 years
2. Uncontrolled clinical conditions like HTN, cancer, HIV, HBsAg, Liver cirrhosis, Cardiac failure, Stroke, etc.
3. History of Metabolic disorder
4. Anemia with any associated severe complication
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Daurbalya(Weakness)
|
3 week
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Hridaspandana(Palpitation),
Panduta(Paleness),Angamarda
(Bodyche),Rukshata(Dryness),
Aruchi(Anorexia), Gaurava(Heaviness)
|
3 week |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
Final Enrollment numbers achieved (Total)= "47"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
04/12/2023 |
| Date of Study Completion (India) |
15/06/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
15/06/2024 |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Clinical study has obtained Institutional Ethics committee clearance (GAC/VAD/IEC/77/2023, Date-24/01/2023) and registered at Clinical Trial Registry of India, ICMR, New Delhi, vide CTRI/2023/08/056119, [Registered on 04/08/2023]. Study type was open labelled clinical trial. 47 patients were enrolled and divided into four groups (i.e., Group A1-A2 – Vataja Pandu, Group B1-B2 – Kaphaja Pandu) 10 patients in each group were allocated. Total 40 patients (i.e., 10 patients in group A1, 10 patients in Group A2, 10 patients in group B1, 10 patients in Group B2) were completed the study. All individual four groups A1, A2, B1 and B2 were having significant difference percentage in Pandu. While, non-significant difference observed between A1-A2 and B1-B2 groups. In overall effect of therapy moderate and mild improvement observed in Group A1 40% and 60%. In Group A2 moderate and mild improvement observed 70% and 39%. Moderate, mild and no improvement observed in Group B1 10%, 60% and 30%. In Group B2 marked, moderate and mild improvement observed 20%, 20% and 60%. |