FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/02/081492 [Registered on: 28/02/2025] Trial Registered Prospectively
Last Modified On: 27/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   observational study 
Study Design  Single Arm Study 
Public Title of Study   An observational study of vitamin B12 deficiency in relation to symptoms of vitiation of Doshas and Rasavaha Strotas (first Srotas or body channel conveying nutritive elements for the first Dhatu or tissue and further Dhatu or tissue) Dushti symptoms 
Scientific Title of Study   An observational study of vitamin B12 deficiency in relation to Doshprakop Lakshanas and Rasavaha Strotodushti Lakshanas. 
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 Mukta Manoj Deshpande 
Designation  PG Scholar 
Affiliation  BVDU College of Ayurved and Hospital, Dhankawadi,Pune 411043 
Address  Bharati Vidyapeeth (Deemed to be University) College of Ayurved and Hospital, Dhanakawadi Katraj Pune 411043

Pune
MAHARASHTRA
411030
India 
Phone  7768971128  
Fax    
Email  mukta.deshpande-ayurved@bvp.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pravina Satish Adhikari 
Designation  Associate professor 
Affiliation  BVDU College of Ayurved and Hospital, Dhankawadi,Pune 411043 
Address  Bharati Vidyapeeth (Deemed to be University) College of Ayurved and Hospital, Dhanakawadi Katraj Pune 411043

Pune
MAHARASHTRA
411043
India 
Phone  9922372566  
Fax    
Email  drpravinasadhikari@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Pravina Satish Adhikari 
Designation  Associate professor 
Affiliation  BVDU College of Ayurved and Hospital, Dhankawadi,Pune 411043 
Address  Bharati Vidyapeeth (Deemed to be University) College of Ayurved and Hospital, Dhanakawadi Katraj Pune 411043

Pune
MAHARASHTRA
411043
India 
Phone  9922372566  
Fax    
Email  drpravinasadhikari@gmail.com  
 
Source of Monetary or Material Support  
Bharati Vidyapeeth (Deemed to be University) College of Ayurved and Hospital,1 st floor Pthology lab, Department of Roganidan Evam Vikriti Vigyan, Dhankawadi Pune- 411043, Maharashtra, India 
 
Primary Sponsor  
Name  Dr Mukta Manoj Deshpande 
Address  B-401 Chintamani Court CHS Shaniwar Peth Pune 30 
Type of Sponsor  Other [self] 
 
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 Mukta Manoj Deshpande  Bharati Vidyapeeth(Deemed to be University) College of Ayurved and Hospital  Bharati Vidyapeeth(Deemed to be University) College of Ayurved and Hospital Department of Roganidan Evam Vikriti Vigyan Dhankawadi Katraj Pune 43
Pune
MAHARASHTRA 
7768971128

mukta.deshpande-ayurved@bvp.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ETHICS COMMITTEE[BV(DU)COA-EC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E00-E89||Endocrine, nutritional and metabolic diseases. Ayurveda Condition: RASAVAHASROTODUSHTIH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients with Vitamin B12 deficiency less than 211 pg/ml
patients with maximum time interval of 30 days after getting Vitamin B12 test reports 
 
ExclusionCriteria 
Details  Pregnant women
Lactating mothers
Terminally ill and immunocompromised patients 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Rasavahastrotodushti and Doshaprakop Lakshanas are observed in B12 deficient patient  1 year 
 
Secondary Outcome  
Outcome  TimePoints 
Other Strotodushti Lakshanas (if any) are observed in B12 deficient patient  1 year 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   N/A 
Date of First Enrollment (India)   15/03/2025 
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="1"
Months="0"
Days="0" 
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  

Vitamin B12 deficiency is worldwide problem including India. While working in Ayurvedic hospital, it is noticed that, most of the symptoms of vitamin B12 deficiency found similar, to that of all Doshaprakop Lakshanas and Rasavaha Strotas Dushti Lakshanas. So, it is my humble attempt to study B12 deficiency symptoms through Ayurvedic perspective. Vitamin B12 deficiency symptoms are anemia, glossitis, numbness, paresthesia, weakness, ataxia, diminished reflexes, mild jaundice, angular stomatitis, purpura, melanin pigmentation, weight loss, anorexia, fatigue, headache, nausea, constipation, bloating, erectile dysfunction, malabsorption, cognitive impairment, irritability, and lethargy, muscle cramps.


Rasavaha Strotas Dushti Lakshanas are disinclination for food, anorexia, foul taste in mouth, lack of taste sensing capacity, nausea, heaviness, drowsiness, malaise, fever, darkness in front of eyes, pale discoloration of skin, obstruction of body channels, impotency, heaviness of body, emaciation, loss of digestive strength, premature wrinkling of skin, greying of hair.


Vata Dushti Lakshanas are flaccidity, dilation, cutting pain, loss of sensation, weakness, pain, pricking needle pain, splitting pain, obstruction, body ache, constriction, twisting, goose bumps, thirst, tremors, roughness, porosity, dryness, pulsation, obstruction, rigidity as if tied, stiffness, astringent taste in mouth, reddish black discoloration. Pitta Dushti Lakshanas are burning sensation, reddish discoloration, increase in body temperature, suppuration, sweating, excess moistness, inflammation with excess secretions, putrefaction, weakness, fainting, delirium (confusion), hot and sour taste in mouth, appearance of colour other than white and crimson. Kapha Dushti Lakshanas are, oiliness, hardness, etching, coldness, heaviness, obstruction, coating as if tied with a wet cloth, stiffness, inflammation, indigestion, excess sleep, white discolouration, sweet and salty taste in mouth, delay in all activities.

  • Conduct of Procedure: 
  •  100 patients approaching for vitamin B12 test in Bharti Ayurveda Hospital will be screened and out of which, vitamin B12 deficient patients (30) (<211pg/ml) will                be recruited according to inclusion and exclusion criteria.
  •  The above topic and methodology will be explained to the patients. Then consent form will be filled  by patients.
  •  Intruments to be used- Case Record Form (C.R.F.) and questionnaire will be prepared and used for assessment of patients.               
  •  Technique- Assessment of the patients will be done by interview technique; using C.R.F. and questionnaire. Questionnaire will be prepared and validated by                       subject expert and statistician.
  •  Subjective parameters will be assessed by presence or absence of Dosh Prakop Lakshanas and Rasavaha Strotodushti Lakshanas in patient as per questionnaire.


 
Close