| CTRI Number |
CTRI/2025/07/091258 [Registered on: 21/07/2025] Trial Registered Prospectively |
| Last Modified On: |
18/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homeopathy along with standard treatment and standard treatment alone in Pre-dialysis chronic kidney disease |
|
Scientific Title of Study
|
Homeopathy as an add-On treatment in Pre-dialysis chronic kidney disease (HOPE): A randomised, double-blind, three-arm, placebo-controlled trial. |
| Trial Acronym |
HOPE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Varanasi Roja |
| Designation |
Research Officer (H)/Scientist-4 |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Room no. 315,Central Council for Research in Homoeopathy, 61-65, Institutional Area,
Janakpuri, New Delhi, India
West
DELHI
110058
India |
| Phone |
9999454036 |
| Fax |
|
| Email |
varanasiroja@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Varanasi Roja |
| Designation |
Research Officer (H)/Scientist-4 |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Room no. 315,Central Council for Research in Homoeopathy, 61-65, Institutional Area,
Janakpuri, New Delhi, India
West
DELHI
110058
India |
| Phone |
9999454036 |
| Fax |
|
| Email |
varanasiroja@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Abhijit Chakma |
| Designation |
Research Officer (H)/Scientist-2 |
| Affiliation |
Regional Research Institute (H), Agartala |
| Address |
Room no. 203, First floor, Regional Research Institute (H) Joy Krishna Kobra Para Road, TTAADC Head Quarter complex , Khumulwng, Jirania, Tripura (W)
West Tripura
TRIPURA
799045
India |
| Phone |
0 |
| Fax |
|
| Email |
dr.abhijit24@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Homoeopathy,61-65, Institutional Area,
Janakpuri, New Delhi - 110058, India |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Homoeopathy |
| Address |
61-65, Institutional Area,
Janakpuri, New Delhi - 110058, India |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Rajesh Kishore Debbarma |
Agartala Govt. Medical College, Tripura |
Room no. 204, II floor, medicine block, Agartala Govt. Medical College PO, Kunjaban, Agartala, Tripura 799006
West Tripura
TRIPURA |
7005400498
dr_rajs@yahoo.co.in |
| Dr Siva Prasad Goli |
Regional Research Institute of Homoeopathy |
Room no. F-12,Regional Research Institute of Homoeopathy, Dr. G.G.H medical college campus,Eluru Road,Loyaada, Gudivada, Andhra Pradesh 521301
Krishna
ANDHRA PRADESH |
9550368653
drsivahomoeo@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional ethics committee for clinical studies |
Approved |
| Institutional ethics committee for clinical studies |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N182||Chronic kidney disease, stage 2 (mild), (2) ICD-10 Condition: N183||Chronic kidney disease, stage 3 (moderate), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Standard care along with Active homeopathic medicine in CH-potency plus dummy LM potency |
The medicines in CH potencies shall be procured from Good Manufacturing Practices certified companies, which will include 6 CH, 30 CH, 200 CH, 1000 CH or higher potencies on case to case basis as dose as well as remedy must be adjusted to the patients need and under homeopathic principles any potency may be required in any case.A double-dummy technique with matching placebos for each active treatment will be applied, thus both placebos will seem identical to their corresponding verum formulations.Follow-up will be on monthly basis for 12 months. |
| Intervention |
Standard care along with Active homeopathic medicine in LM-potency plus dummy CH potency |
The medicines in LM potencies shall be procured from Good Manufacturing Practices certified companies, which started with 0/1 potency, followed by next higher potency, serially, as per the need of the case. The investigator will train the pharmacist and instruct the patients/relatives for the preparation and dispensing of LM potencies with precision as follows: One globule (poppy-seed size) of the desired potency was dissolved in 120 ml of distilled water, containing 2.4 ml (2% v/v) of dispensing alcohol, premixed in it, followed by ten uniformly-forceful downward strokes given against the bottom of the phial. The medicine was given once daily in the morning, on an empty stomach as long as improvement continued. Any change triggered after administration (status quo/improvement/deterioration/) led to frequent repetition/change of remedy following homoeopathic principles. |
| Comparator Agent |
Standard care along with CH potency placebo plus LM potency placebo. The placebos were identical to the respective verum medication. |
Patients will receive placebos in CH and LM potencies, as previously described along with standard care |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Both genders. Age 18 years to 70 years. Stage II with 60-89 ml/min/1.73m2 or stage III with GFR 59-30 ml/min/1.73m2 of CKD as per Kidney Disease: Improving Global Outcomes (KDIGO) guidelines. Albumin-to-creatinine ratio (ACR) more than or equal to 30mg/g [more than or equal to 3mg/mmol]. Written informed consent.
|
|
| ExclusionCriteria |
| Details |
Pregnant or lactating women.
Patients with acute kidney injury, polycystic kidney disease.
Patients with self-reported systemic illnesses such as cancer/HIV/ Hepatitis-B /Auto-immune diseases.
Serious health issues requiring urgent medical/supportive treatment.
Patients on peritoneal dialysis, haemodialysis, or kidney transplantation and a GFR less than 29ml/(min·1.73 m2).
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the changes in Serum Creatinine levels and eGFR value |
Baseline, Month 1,2,3,4,5,6,7,8,9,10,11,12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Proportion of patients progressed to first dialysis stage and its progression time-period |
Baseline to progression to first dialysis stage |
| Quality of life using KDQOL-SF™ 1.3 questionnaire |
Month 3, 6, 9, 12 |
| Changes in urine albumin to creatinine ratio |
Baseline, Month 1,2,3,4,5,6,7,8,9,10,11,12 |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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 |
|
Date of First Enrollment (India)
|
01/12/2025 |
| 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="3"
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
|
Chronic kidney disease (CKD) is a non-communicable, slowly progressive, irreversible loss in the functioning of kidneys that usually develops over a period of years. According to World Health organization (WHO) Global Burden of Disease project, diseases of the kidney and urinary tract contribute to global burden with approximately 850,000 deaths every year and 115,010,107 disability adjusted life years. CKD is the 12th leading cause of death and 17th cause of disability. Complementary and alternative medicine (CAM) may provide new therapeutic options for the patients with CKD progressing to ESRD with the goal of improving symptoms and QOL. There are very primitive studies undertaken in homoeopathy to evaluate the role of homoeopathy in CKD, whereas studies on QOL is still lacking. No quality works have been carried out upon QOL among CKD patients. Therefore this study has been proposed to determine the effectiveness of add-on homoeopathy to the standard care among pre-dialysis patients suffering from chronic kidney disease. It is a randomized, placebo-controlled, double-blind, double-dummy, three parallel arm study to be conducted at Agartala Govt. Medical College, Tripura and Regional Research Institute (H), Gudivada. Patients of both genders, 18-70 years of age with stage II or stage III CKD as per Kidney Disease: Improving Global Outcomes (KDIGO) guidelines & having albumin-to-creatinine ratio (ACR) more than or equal to 30mg/g [more than or equal to 3mg/mmol] and who gave written informed consent will be included. After inclusion, patients will be randomly assigned in a 1:1:1 ratio using a computer-generated random allocation sequence to either one of three groups: Standard care along with Active homeopathic medicine in CH-potency plus dummy-LM potency; Standard care along with Active homeopathic medicine in LM-potency plus dummy-CH potency; and Standard care along with CH potency placebo plus LM potency placebo. The medicines which the participant is taking before enrolment will be continued during the study period. The study duration is of 3 years and sample size calculated is 100 participants in each group. The primary outcome is to note the changes in Serum Creatinine levels and eGFR value over 12 months. All the data will be collected and statistical analysis will be done as appropriate i.e. parametric for continuous data and non- parametric for ordinal or count data. |