An open labeled randomised controlled clinical study to assess the efficacy of Trushna Shamak Yavagu in the alleviation of chemotherapy induced side effects in Breast cancer patients.
Overview
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Dr.Nisha Sane
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Improvement on MSAS scale
Overview
Brief Summary
This study is randomised , open labeled ,parallel group, single centre trail assessing the efficacy of Trushna Shamak Yavagu 80 ml twice a day for 63 days to alleviate the side effects of chemotherapy in breast cancer female patients.The primary outcome measure will be alleviation of chemotherapy induced side effects in these patients. The secondary out come will be the improvement of quality of life in them. The assessment of MSAS scale will be done every after 7 days for completion of 3 chemo cycles.
After the enrolment of the patient the posology will be followed. The consent form will be taken prior to the trial on the second chemo day and the drug will be dispensed for next 21 days (42 sachets of TSY with 5 extra sachets of TSY. The extra TSY is given in case of any spillage.
The TSY sachets will be named and numbered. The patients are asked to keep the empty sachets carefully to give it back at the time of next TSY dispensing to ensure the administration of complete drug. Scale will be checked and recorded on that day.
1st follow up will be after 7 days, which is the 8th day of 2nd chemotherapy cycle. The scale will be checked to assess the immediate side effects of chemotherapy.
On the 15th day the 2nd follow up will be recorded to assess the delayed side effects of chemotherapy.
3rd follow up will be on the 3rd chemotherapy cycle which will be 21st day of 2nd chemo and 1st day of 3rdchemotherapy. The scale will be recorded. The first set of empty TSY sachets will be collected back and the 2nd pack of named and labelled TSY will be handed over to the patient. If any extras are used due to any spillage the extra sachets will be replaced.
4th follow up will be 8th day of 3rd chemotherapy cycle to record the immediate side effects of chemotherapy.
5th follow up will be recorded on the 15th day of 3rd chemotherapy cycle to assess the delayed side effects of chemotherapy.
6th follow up**-** 1st day of 4th chemotherapy and 21st day of 3rd chemotherapy cycle. Scale will be recorded. The second set of empty TSY sachets will be collected back and the 3rd pack of named and labelled TSY will be handed over to the patient. If any extra used due to any spillage the extra sachet will be replaced.
7th follow up will be on 8th day of 4th chemotherapy cycle to record the immediate side effects of chemotherapy.
8th follow up will be on the 15th day of 4th chemotherapy cycle to record the delayed side effects of chemotherapy.
9th follow up will be 21st day of 4th chemotherapy cycle.
The records of every follow-up will be studied together, and results will be drawn. There will be comparison between immediate side effects(8th day) and delayed side effects(15th day) with 21st day every chemotherapy cycle. Also there will be comparison between every cycle of chemotherapy in individuals. There will be comparison-base devaluation in Control-Group and Trial-Group to get the final results.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •1.Diagnosed carcinoma (breast) patients on chemotherapy 2.Age 18 to 60 years of females 3.Patients with mild to moderate side effects 4.Controlled Diabetes Mellitus & Hypertension.
Exclusion Criteria
- •1.Cycle 01 of Chemotherapy 2.With severe cases of side effects 3.Uncontrolled Diabetes Mellitus & Hypertension, Pregnant and Lactating women, With contagious diseases such as TB or Hepatitis C.
Outcomes
Primary Outcomes
Improvement on MSAS scale
Time Frame: every 7 days for 63 days
Secondary Outcomes
- Any effect on Quality of life(every 30 days till 63 days)
Investigators
Dr Nisha Sane
D.Y.Patil School of Ayurveda