| CTRI Number |
CTRI/2024/06/068440 [Registered on: 06/06/2024] Trial Registered Prospectively |
| Last Modified On: |
09/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effect of punarnavashtak kwath in patients with iron deficiency anemia |
|
Scientific Title of Study
|
Clinical evaluation of the efficacy of punnarnavashtak kwath in the management of pandu rog w.s.r. to iron deficiency anaemia - a randomized controlled trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aniket Purushottam Raut |
| Designation |
PG Scholar (Kayachikitsa) |
| Affiliation |
Radhakisan Toshniwal Ayurved Mahavidyalaya, Akola |
| Address |
Room no.1, Kayachikitsa Department, Radhakisan Towshniwal Ayurved Mahavidyalaya, Kediya plots, Jatharpeth Road, Akola
Akola
MAHARASHTRA
444005
India |
| Phone |
8624898662 |
| Fax |
|
| Email |
aniketraut101@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sadhana Ashutosh Kulkarni |
| Designation |
HOD and Professor (Kayachikitsa ) |
| Affiliation |
Radhakisan Toshniwal Ayurved Mahavidyalaya, Akola |
| Address |
Room no.1, Kayachikitsa Department, Radhakisan Toshniwal Ayurved Mahavidyalaya, Kediya Plots, Jatharpeth Road, Akola
Akola
MAHARASHTRA
444005
India |
| Phone |
9422939510 |
| Fax |
|
| Email |
drsadhana.k@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aniket Purushottam Raut |
| Designation |
PG Scholar (Kayachikitsa) |
| Affiliation |
Radhakisan Toshniwal Ayurved Mahavidyalaya, Akola |
| Address |
Room no.1, Kayachikitsa Department, Radhakisan Toshniwal Ayurved Mahavidyalaya, Kediya Plots, Jatharpeth Road, Akola
Akola
MAHARASHTRA
444005
India |
| Phone |
8624898662 |
| Fax |
|
| Email |
aniketraut101@gmail.com |
|
|
Source of Monetary or Material Support
|
| Radhakisan Toshniwal Ayurved Hospital , Akola |
|
|
Primary Sponsor
|
| Name |
Dr Aniket Purushottam Raut |
| Address |
Room no.1, Kayachikitsa Department, Radhakisan Toshniwal Ayurved Mahavidyalaya, Kediya Plots, Jatharpeth Road, Akola |
| 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 Aniket Purushottam Raut |
Radhakisan Toshniwal Ayurved Hospital |
Room no.1, Kayachikitsa Department, Kediya Plots,Jatharpeth Road, Akola
Akola
MAHARASHTRA |
8624898662
aniketraut101@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| R. T. Ayurved Mahavidyalaya Akola |
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: Punarnavashtak kwatha, Reference: Bhaishajya ratnavali, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 40 Days, anupAna/sahapAna: No, Additional Information: - Follow up of each patient after every 10 days (for 60 days) | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Vasadi kwatha, Reference: Bhaishajya ratnavali, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 40 Days, anupAna/sahapAna: Yes(details: - Madhu), Additional Information: - Follow up of each patient after every 10 days (for 60 days) |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients presenting with classical signs and symptoms of Pandu Rog i.e. Panduta, Daurbalya, Aruchi, Aalaysa, Shwas , Hridyaspandan and Gatrashool will be selected . Minimum 4 symptoms from above will be included .
2) Age with age group 18 – 60 yrs.
3) Haemoglobin level - below 12 gm/dl in Female and below 13 gm/dl in Male
4) Serum Ferritin - below 30 ng/ml in Female and below 50 ng/ml in Male
5) Patients will be selected irrespective of Gender , Occupation and Socioeconomic status . |
|
| ExclusionCriteria |
| Details |
1) Age less than 18 yrs and more than 60 yrs. 2) Haemoglobin level below 5 gm/dl
3) Pregnant and lactating mother
4) Any Bleeding Disorders e.g. Haematemesis , Bleeding Piles etc.
5) Anaemia other than Iron Deficiency Anaemia . 6) Severe Renal / Hepatic / Cardiac disease
7) Those Patients not willing for trial and not giving written consent . |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement Hb%
1. Marked Increased greater than or equal to 1.5 gm/dl
2. Moderate Increased by 1 to 1.4 gm/dl
3. Mild Increased by 0.5 to 0.9 gm/dl
4. Poor Increased by 0 to 0.4 gm/dl
Improvement Serum Ferritin
1. Marked Increase greater than 3 ng/dl
2. Moderate Increase by 2.1 to 3 ng/dl
3. Mild Increase by 1.1 to 2 ng/dl
4. Poor Increase by 0 to 1 ng/dl |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in subjective parameters such as
1) Panduta ( Pallor ) 2) Daurabalya ( Weakness ) 3) Aruchi ( Anorexia ) 4) Aalaysa ( Inactivity) 5) Shwas (Dyspnoea) 6) Hrudyaspandan (Palpitation) 7) Gatrashula ( Bodyache) |
2 months |
|
|
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/ Phase 4 |
|
Date of First Enrollment (India)
|
17/06/2024 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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 is a randomized , single blind , parallel group , controlled trial to evaluate punarnavashtak Kwath is more efficative than Vasadi Kwath in the management of Pandu Rog w.s.r. to Iron Deficiency Anemia for 12 months in 60 patients will be conducted in India . The primary outcome measures improvement in Hemoglobin percentage and serum Ferritin level . The secondary outcome measures improvement in subjective parameters such as Panduta , Daurbalya , Aruchi , Aalasya , Shwas , Hridyaspandan , Gatrashoola . |