CTRI Number |
CTRI/2022/11/047446 [Registered on: 21/11/2022] Trial Registered Prospectively |
Last Modified On: |
18/11/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Ayurveda |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
A Clinical Study Of Vardhaman Pippali Rasayan and Vidangadi Loha In Anaemia |
Scientific Title of Study
|
Randomised Controlled Clinical Trial Of Add-on Effect Of Vardhaman Pippali Rasayana On Vidangadi Loha In Management Of Pandu. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Khushali Sanjay Shroff |
Designation |
PG Scholar |
Affiliation |
Tilak Ayurved Mahavidyalay, Pune |
Address |
Department of Kayachikitsa, Tilak Ayurved Mahavidyalaya, Rastapeth,Pune 11 Department of Kayachikitsa, Tilak Ayurved Mahavidyalaya, Rastapeth, Pune 11 Pune MAHARASHTRA 411011 India |
Phone |
9769559144 |
Fax |
|
Email |
shroff.khushali4@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Abhaychandra S Inamdar |
Designation |
Associate Professor, Kayachikitsa dept |
Affiliation |
Tilak Ayurved Mahavidyalay, Pune |
Address |
Department of Kayachikitsa,1st floor, Institutional building, Tilak Ayurved Mahavidyalaya,Rastapeth,Pune 11 Department of Kayachikitsa, 1st floor, Institutional building, Rastapeth, pune 11 Pune MAHARASHTRA 411011 India |
Phone |
9767318431 |
Fax |
|
Email |
drasinamdar@yahoo.com |
|
Details of Contact Person Public Query
|
Name |
Dr Abhaychandra S Inamdar |
Designation |
Associate Professor, Kayachikitsa dept |
Affiliation |
Tilak Ayurved Mahavidyalay, Pune |
Address |
department of Kayachikitsqa, 1st floor, Institutional Building, Tilak Ayurved Mahavidyalaya, Rastapeth, Pune 11 Department of Kayachikitsa, 1st floor, Institutional building, Tilak Ayurved Mahavidyalaya, RAstapeth, Pune 11 Pune MAHARASHTRA 411011 India |
Phone |
9767318431 |
Fax |
|
Email |
drasinamdar@yahoo.com |
|
Source of Monetary or Material Support
|
Tilak Ayurved Mahavidyalaya, Rastapeth, Pune 11 |
|
Primary Sponsor
|
Name |
Tilak Ayurved Mahavidyalaya Pune |
Address |
TILAK AYURVED MAHAVIDYALAYA, RASTA PETH, PUNE 11 |
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 |
Dr Khushali Sanjay Shroff |
SETH TARACHAND RAMNATH CHARITABLE AYURVED HOSPITAL |
OPD no. 5/6/13, under Deartment of Kayachikitsa Pune MAHARASHTRA |
9769559144
shroff.khushali4@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethical Committee,Tilak Ayurved Mahavidyalaya and Seth Tarachand Ramnath Charitable Ayurved Hospital, Rastapeth, Pune |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:E611||Iron deficiency. Ayurveda Condition: PANDUROGAH, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: VIDANGADI LOHA, Reference: CHAKRADATTA PANDU CHIKITSA 33-34, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: LUKEWARM WATER), Additional Information: - | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: VARDHAMAN PIPPALI RASAYAN, Reference: SHARANGDHAR MADHYAM KHAND 4, Route: Oral, Dosage Form: Ksheerpaka, Dose: 3(NA), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
Inclusion Criteria
|
Age From |
15.00 Year(s) |
Age To |
49.00 Year(s) |
Gender |
Female |
Details |
1)The presence of symptoms of Pandu as described in classical Ayurvedic texts such as Panduta, Dourbalya, Shirshoola, Shwasa, Hridaspandan, Aruchi, Akshi koota shotha, Pindikoudveshthan, Bhrama, Rukshata, Gourava and Shrama.
2)Women of reproductive age group of 15-49 years
3)Patients having history of Hb% <12 g% (Female) , low mean corpuscular volume (MCV) (<80 fl); serum iron <50 µg/dl, total iron binding capacity (TIBC) >360 µg/dl.
|
|
ExclusionCriteria |
Details |
1)Patients having history of Haemoglobin <7 gm%
2)Patients suffering from haematological disorders such as sickle-cell anaemia and thalassemia are excluded.
3)Patients having history of systemic disorders such as uncontrolled hypertension, uncontrolled diabetes mellitus, AIDS, and cancer.
4)Pregnant females and lactating mothers.
5)Gynaecological diseases like Menorrhagia and Obstetric disorders leading to blood loss
6)Grishma and Sharad Ritu.
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
An Open list of random numbers |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
Improvement in PANDUTA, DOURBALYA, SHIRASHOOLA, SHWAS ,HRIDSPANDAN, ARUCHI, AKSHIKOOTA, SHOTH, PINDIKODWESHTAN, BHRAMA, RUKSHATA, GAURAVA, SHRAMA, Hb% ,RBC, MCV, MCH, MCHC and TIBC |
baseline,10th day, 21st day |
|
Secondary Outcome
|
Outcome |
TimePoints |
to study the adverse effects of Vardhaman Pippali rasayan, if any |
21 days |
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
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 2/ Phase 3 |
Date of First Enrollment (India)
|
23/11/2022 |
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
|
not yet published
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
One of the specialities of Ayurveda
is the rasayana karma mentioned in it. Diseases like Pandu are not only caused
by some dietary causes but it is majorly impacted by the person’s nutrition
hence while treating Pandu, only the disease curing (Vyadhi pratyanik chikitsa)
strategy does not help but supplemental help (Rasayana Chikitsa) to prolong its
effect is also very much necessary. Hence here in case of Pandu Vidangadi loha
can be used to treat the basic cause of the disease but to get better results
in the management of the disease subject will be given supplemental meaning
Rasayan vidhi to prolong its effect. And Pippali’s rasayana karma can be
studied through this in Pandu. Vardhaman Pippali Rasayana is explained by
Sharangdhar in his texts in Madhyam khanda, as useful in treating Pandu Vyadhi
by its Rasayana, Deepana & Pachana, Raktvardhak, Raktashodhak property. It
is also mentioned in Charak Samhita for the same. Hence, this is an attempt to
evaluate the efficacy of Vardhaman Pippali Rasayana on the basis of subjective
and objective parameters. women of age group of 15 to 49 years. Intervention drug is administered with primary outcome of improvement in clinical signs and symptoms of Pandu and
improvements in laboratory parameters and changes in quality of life as secondary outcome. Assesments are
done at baseline and after 21 days of treatment and patients are followed up for a period of 1 months after
completion of treatment for any recurrence of the signs and symptoms. As per the study protocol sufficient
number of subjects has been registered and recruitment is complete.
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