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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E611||Iron deficiency. Ayurveda Condition: PANDUROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(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: -
2Intervention ArmDrugClassical(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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