| CTRI Number |
CTRI/2024/05/067749 [Registered on: 21/05/2024] Trial Registered Prospectively |
| Last Modified On: |
08/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Ruta graveolens,a Homoeopathic medicine in the treatment of Colorectal cancer |
|
Scientific Title of Study
|
Phytochemical screening of ruta graveolens mother tincture and clinical
effectiveness of ruta graveolens 30c in comparison with individualized homoeopathic medicine on colorectal cancer patients in respect to carcinoembryonic antigen:an open label non
randomised clinical trial |
| 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 Rashmi Rekha Naik |
| Designation |
Post graduate trainee |
| Affiliation |
National Institute of Homoeopathy |
| Address |
National Institute of Homoeopathy, Block GE, Sector 3, Salt lake, Kolkata,West Bengal, Pin 700106
North Twentyfour Parganas
West Bengal
700106
India
North Twentyfour Parganas
WEST BENGAL
7000106
India |
| Phone |
8917552130 |
| Fax |
|
| Email |
rashmirekha270@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gitasri Pal |
| Designation |
Professor |
| Affiliation |
National Institute Of Homoeopathy |
| Address |
Department of Homoeopathic Pharmacy, OPD number 19, National Institute of Homoeopathy, Block GE, Sector 3, Salt lake, Kolkata
North Twentyfour Parganas
West Bengal
Pin 700106
India
Kolkata
WEST BENGAL
700106
India |
| Phone |
8910624248 |
| Fax |
|
| Email |
drgitasripal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gitasri Pal |
| Designation |
Professor |
| Affiliation |
National Institute Of Homoeopathy |
| Address |
Department of Homoeopathic Pharmacy, OPD number 19, National Institute of Homoeopathy, Block GE, Sector 3, Salt lake, Kolkata
North Twentyfour Parganas
West Bengal
Pin 700106
India
Kolkata
WEST BENGAL
700106
India |
| Phone |
8910624248 |
| Fax |
|
| Email |
drgitasripal@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Homoeopathy, Block GE, Sector 3, Salt lake, Kolkata
North Twentyfour Parganas
West Bengal
Pin 700106
India |
|
|
Primary Sponsor
|
| Name |
National Institute Of Homoeopathy |
| Address |
National Institute Of Homoeopathy, Block GE ,Sector 3, Salt lake, Kolkata
North Twentyfour Parganas
Pin 700106
West Bengal ,India |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rashmi Rekha Naik |
National Institute of Homoeopathy |
Department of Homoeopathic Pharmacy, OPD number 19, Block GE, Sector 3, Salt lake, Kolkata
North Twentyfour Parganas
WEST BENGAL |
8917552130
rashmirekha270@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| National Institute Of Homoeopathy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C20||Malignant neoplasm of rectum, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Individualized Homoeopathic medicine |
Individualized Homoeopathic medicine will be selected as per the totality of symptom and administered in centesimal potency, Follow up will be done on regular basis (and as per need of the patients mainly at baseline, three months and six months) for at least sixth
months to ascertain the improvement |
| Intervention |
Ruta graveolens 30C in one arm and Individualised Homoeopathic medicine in
another arm |
Ruta graveolens 30C,a Homoeopathic medicine will be prescribed as per the homoeopathic principles, if 50% of symptoms corresponds as given in appendix and dose will be selected according to susceptibility of patients and route of administration is oral
Follow up will be done on regular basis (and as per need of the patients especially at baseline, three months and six months) for at least sixth
months to ascertain the improvement
On each occasion, single Individualised Homoeopathic medicine is prescribed considering symptom totality, clinical history details, constitutional traits, miasmatic features and
repertorization as and when
required
Subsequent prescription is produced in
accord with Kents observations and Herings law of cure |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients of all genders, different religions and socioeconomic groups.
Age between 18-80 years.
Histologically confirmed Colorectal cancer patients.
In case the medicine does not provide relief or aggravate the patients condition and the
disease progresses further, immediate care will be taken by providing the proper dose of medicine
Patients having Colorectal Malignancy of any histological type at any stage except
those mentioned under exclusion.
Patients who are otherwise untreated and have opted for homoeopathic treatment.
Patients who have already had Surgery, Radiotherapy or Chemotherapy but now intend
to undergo homoeopathic treatment.
Patient willing to give written consent for participating in the study and complete
follow-up during study. |
|
| ExclusionCriteria |
| Details |
Patients who continue to be under Chemotherapy or Radiotherapy.
Pregnant and Lactating women.
Patients not willing to undergo any investigation, even after advised.
Individuals unwilling to get solely homoeopathic treatment.
Patients in the terminal stage of illness.
Diagnosed cases of unstable mental or psychiatric illness. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Tumor biomarker CEA will be evaluated
|
At baseline, after 3 months and 6 months of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The response of the patients will be observed and improvement in Quality of Life will be
assessed with EORTC QLQ-CR29 scale |
at baseline,
after 3 months & 6 months of treatment |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 3 |
|
Date of First Enrollment (India)
|
30/05/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Following preliminary and detailed screening using specified selection (inclusion and
exclusion) criteria, eligible patients will be recruited for the trial. Each case will be studied properly through analysis and evaluation of symptoms and the
symptoms will be matched against the symptoms of Ruta graveolens and if at least 50% symptoms would be present then it will be
included in the study group 1 and if not then it will be included under study group 2. Evaluation of symptoms as per homoeopathic literature and practice. Selection of medicine in consultation with homoeopathic Materia Medica and
therapeutics on the basis of instructions given by Dr. C. F. S. Hahnemann in the Organon
of Medicine for individualized group. Tumor biomarker CEA will be evaluated at baseline, 3 months and 6 months of post
intervention therapy and will be compared in the both groups of patients . Scoring of Quality of Life of colorectal malignancy patient will be evaluated using
EORTC QLQ –CR29 scoring system. The response will be duly graded as per the EORTC QLQ- CR29 scoring system. Observing the response of the patient through signs and symptoms and improvement in
Quality of Life by EORTC QLQ- CR29 scoring system and reviewing of homoeopathic
prescription on the basis of response of the patient. Relevant clinical examination. Relevant investigative procedures will be done as per need of the case. Follow up will be done on regular basis (and as per need of the patients) for at least sixth
months to ascertain the improvement. The assessment of changes in value of Tumor Biomarker CEA will be done at baseline,
after 3 months & 6 months of treatment. The response of the patients will be observed and improvement in Quality of Life will be
assessed with EORTC QLQ-CR29 scale at baseline, after 3 months and 6 months of
treatment. Group differences (independent observations) will be tested at baseline (to check
compatibility), after 3 months and after 6 months (to check effectiveness). After the
completion of the study dependent observations of continuous outcomes at baseline and
at different points of time will also be compared using appropriate statistical tests |