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Clinical Trials/CTRI/2019/03/018112
CTRI/2019/03/018112CompletedPhase 2/3

An interventional comparative clinical study on Guduchyadi Karma Basti and Rasayana Avaleha in the management of Cancer W.S.R. Gastro-intestinal cancer

IPGT and RA GAU jamnagar1 site in 1 country30 target enrollmentStarted: March 20, 2019Last updated:

Trial Snapshot

Phase
Phase 2/3
Status
Completed
Sponsor
Enrollment
30
Locations
1
Primary Endpoint
efficacy

Study Overview

Brief Summary

This study is An randomized Interventional Comparative Clinical trial to evaluate the effect of Guduchyadi Karma Basti and Rasayana Avaleha in the Management of Cancer w.s.r. Gastro-intestinal Cancer. total 30patients will be enrolled in present study. Selected patients will be divided in three group on the basis of computer generated randomisation. in this study in group A Guduchyadi Karma Basti which is combination of Guduchi Ghrita Anuvasana Basti(100ml to 120ml ) and Guduchyadi Niruha Basti(600ml to 900ml) will be given though rectal route for 30 day in alternate day pattern and in group B Guduchyadi Karma Bastiwhich is combination of Guduchi Ghrita Anuvasana Basti(100ml to 120ml ) and Guduchyadi Niruha Basti(600ml to 900ml) will be given though rectal route for 30 day in alternate day pattern with Rasayana Avaleha  30gm per day for 30 day will be given and efficacy compared with palliative conservative medicine for cancer treatment or in follow up in cancer treatment.

Conclusion

·        Guduchyadi Karma Basti with Rasayana**Avaleha are better management for cancer patients to improving theirQuality of life.

·        Guduchyadi Karma Basti with Rasayana**Avaleha shows better management for cancer patients to reducing chiefcomplaint like Nusea, vomiting, Dysphasia constipation, fatigue abdominal pain,localized pain and loss of appetite.

·        Guduchyadi Karma Basti with Rasayana**Avaleha able to pacify Urinary tract infection by reducing pus cell,epithelial cell and albumin from urine

·        Guduchyadi Karma Basti with Rasayana**Avaleha more cost effective rather than other conventional moderntreatment and able to reduce economic burden of cancer patients and theirfamily

·        Thus, it is concludedthat Null hypothesis H0 and Alternative hypothesis H1 is rejected. WhileAlternative hypothesis H2 is accepted.

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Open Label

Eligibility Criteria

Ages
18.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patients with histopathologically proved diagnosed as 1st and 2nd stage of Gastro-intestinal Cancer From oral cavity to large intestine Patients who are suitable for Basti Karma Willing and able to participate in the study.

Exclusion Criteria

  • Patients diagnosed as 3rd and 4th stage of cancer of any type Chronic long term local adverse effects.
  • Known cases of hypertension or ischemic heart disease and acute infection etc Patients with ano-rectal carcinoma Cachexic or terminally ill patients.

Outcomes

Primary Outcomes

efficacy

Time Frame: prospective

Secondary Outcomes

  • Safety(prospective)

Investigators

Sponsor
IPGT and RA GAU jamnagar
Sponsor Class
Research institution and hospital

Study Sites (1)

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