FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2026/01/102409 [Registered on: 29/01/2026] Trial Registered Prospectively
Last Modified On: 29/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Radiation Therapy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Assessing the Role of Bhallataka Ghrita Alongside Radiotherapy in Breast Cancer Treatment 
Scientific Title of Study   A controlled comparative in-vitro and clinical study to assess the efficacy of bhallataka ghrita along with radiotherapy in the management of breast carcinoma 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  KAVITA MEENA 
Designation  MD SCHOLAR 
Affiliation  faculty of ayurveda ims bhu  
Address  Department of kayachikitsa IMS BHU Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  9314477845  
Fax    
Email  meenakavita2040@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof O P SINGH 
Designation  Professor 
Affiliation  faculty of ayurveda ims bhu  
Address  Department of kayachikitsa IMS BHU Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  9415818732  
Fax    
Email  singhopbhu@gmail.com  
 
Details of Contact Person
Public Query  
Name  Prof O P SINGH 
Designation  Professor 
Affiliation  faculty of ayurveda ims bhu  
Address  Department of kayachikitsa IMS BHU Varanasi


UTTAR PRADESH
221005
India 
Phone  9415818732  
Fax    
Email  singhopbhu@gmail.com  
 
Source of Monetary or Material Support  
Department of kayachikitsa ims bhu Varanasi 221005 INDIA 
Department of medicinal chemistry ims bhu varanasi 221005 INDIA 
Department of radiotherapy ims bhu varanasi 221005 INDIA 
department of sangyaharan ims bhu varanasi 221005 INDIA 
 
Primary Sponsor  
Name  BANARAS HINDU UNIVERSITY 
Address  LANKA BHU VARANASI 221005 INDIA 
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 KAVITA MEENA  ssh bhu varanasi  BHU LANKA VARANASI
Varanasi
UTTAR PRADESH 		 9314477845

meenakavita2040@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
BANARAS HINDU UNIVERSITY INSTITUTE OF MEDICAL SCIENCES INSTITUTIONAL ETHICS COMMITTEE VARANASI  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:C509||Malignant neoplasm of breast of unspecified site. Ayurveda Condition: ARBUDAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Bhallataka Ghrita, Reference: Chakradatta, Route: Oral, Dosage Form: Ghrita, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 9 Weeks, anupAna/sahapAna: Yes(details: -Lukewarm water), Additional Information: -With Radioltherapy
2Intervention ArmProcedure-N (Procedure Reference: modern, Procedure details: Radiotherapy: 39 Gy/13 fractions/3 weeks on 6 MV Linear Accelerator with Intensity Modulated Radiotherapy (IMRT).)
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  Histopathologically confirmed cases of carcinoma of the breast
Stage 1st to 3rd
Age:30yrs-60yrs
Sex: female
No history of any other carcinoma in the past
• Has undergone modified radical mastectomy/Breast conversational surgery
• Planned for radiotherapy
 
 
ExclusionCriteria 
Details  Patients suffering from systemic disorders (like Diabetes Mellitus, Cardiac diseases, Pulmonary Tuberculosis, Essential Hypertension, SLE, Infectious Arthritis, Hypertrophic Arthropathy)
Pregnant & Lactating women
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. In-Vitro – Evaluation of the cytotoxic effect of Bhallataka extract on malignant breast cancer cell lines
2. Clinical outcome- assessment of the efficacy of Bhallataka ghrita as an adjuvant to radiotherapy in the patients with Breast cancer
3. Secondary outcome –Evaluation of quality life improvements in patients using integrative treatment.
 		 9 Weeks
 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary outcome –Evaluation of quality life improvements in patients using integrative treatment.
 		 9 weeks 
 
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 2/ Phase 3 
Date of First Enrollment (India)   09/02/2026 
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  

The Patients eligible for the study will be randomised into two arms. Lottery method will be used for the randomization.

Standard Arm:

      Radiotherapy: 39 Gy/13 fractions/3 weeks on 6 MV Linear Accelerator with Intensity Modulated Radiotherapy.

       Clinical evaluation and CBC, LFT & RFT will be done once a week during radiotherapy.

       Placebo will be given during radiotherapy.

        Patient will be called up for monthly follow-up for six months.

      Clinical Examination, CBC, LFT and RFT will be done on every follow-up.

       Placebo given for another 9 weeks after radiotherapy.

 

Study Arm:

   Radiotherapy: 39 Gy/13 fractions/3 weeks on 6 MV Linear Accelerator with Intensity Modulated Radiotherapy (IMRT).  

  Clinical evaluation and CBC, LFT & RFT will be done once a week during radiotherapy.

      Bhallatka ghrit (3gm/dose) with luke warm water will be given twice daily for three weeks during radiotherapy.

      Patient will be called up for monthly follow-up for six months.

      Clinical Examination, CBC, LFT and RFT will be done on every follow-up.      Bhallataka ghrit (3gm/dose) with luke warm water will be given twice daily for another 9 weeks after completion of radiotherapy.

 
Close