| CTRI Number |
CTRI/2025/02/081057 [Registered on: 21/02/2025] Trial Registered Prospectively |
| Last Modified On: |
12/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of renal pack on renal functions in diabetic individuals - a randomized controlled trial |
|
Scientific Title of Study
|
Impact of renal pack practised in yoga and naturopathy system of medicine on the renal function in patients with type 2 diabetes mellitus - a randomized controlled 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 S Madesh |
| Designation |
PG Scholar |
| Affiliation |
Government Yoga and Naturopathy Medical College & Hospital, Chennai-106 |
| Address |
Department of Naturopathy, Second floor, Government Yoga and Naturopathy Medical College & Hospital, PG Block, Arumbakkam, Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9944574217 |
| Fax |
|
| Email |
drmadeshbnys@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A Mooventhan |
| Designation |
Assistant Medical Officer cum Lecturer, Department of Research |
| Affiliation |
Government Yoga and Naturopathy Medical College & Hospital, Chennai-106 |
| Address |
Department of Research, Second floor, Government Yoga and Naturopathy Medical College & Hospital, PG Block, Arumbakkam, Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9844457496 |
| Fax |
|
| Email |
dr.mooventhan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Madesh |
| Designation |
PG Scholar |
| Affiliation |
Government Yoga and Naturopathy Medical College & Hospital, Chennai-106 |
| Address |
Department of Naturopathy, Second floor, Government Yoga and Naturopathy Medical College & Hospital, PG Block, Arumbakkam, Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9944574217 |
| Fax |
|
| Email |
drmadeshbnys@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Yoga and Naturopathy Medical College & Hospital, Chennai 600106 |
|
|
Primary Sponsor
|
| Name |
Government Yoga and Naturopathy Medical College & Hospital |
| Address |
Government Yoga and Naturopathy Medical College & Hospital, Chennai 600106 |
| 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 S Madesh |
Governmet Yoga and Naturopathy Medical College & Hospital, Chennai-106 |
Government Yoga and Naturopathy Medical College & Hospital, PG block 2nd floor ,Dept of Naturopathy, Room No -1, Arumbakkam, Chennai-106
Chennai
TAMIL NADU |
09944574217
drmadeshbnys@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Yoga and Naturopathy Medical College & Hospital, Chennai Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional medications |
The participants will be advised to follow their regular conventional medications during the study
period of 1 week. |
| Intervention |
Renal Pack |
Renal pack is a hydrotherapeutic modality in which the back (from the middle dorsal region to the
coccyx) will be exposed to hot application(42-45 deg C), whereas the abdomen (from the mid
epigastric region to the mid-hypogastric region) will be exposed to cold application(12-15 deg C)
simultaneously for 20 minutes for a period of 1 week. The intervention will be administered in the supine lying position,
where the hot fomentation bag will be kept over the back and the ice bag on the abdominal region.
Participants will be covered with cotton cloth and wrapped in a woolen blanket. Temperature will
be checked every 5 minutes with a calorimeter, and water will be replaced. This intervention will be
administered once a day for a week. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Age: 30 to 55 years.
2. Gender: Both male and female.
3. Participants with known cases of T2DM.
4. Participants on regular oral anti-diabetic medications. |
|
| ExclusionCriteria |
| Details |
1. Participants undergoing dialysis.
2. Participants with difficulty in supine lying.
3. Participants underwent recent abdominal surgery.
4. Participants with psychiatric disease.
5. Pregnant women.
6. Women during menstruation.
7. Participants in another clinical trial in the previous three months.
8. General hydrotherapy contra-indication (hydrophobia, hypersensitive skin, open cuts and
wounds and recent fracture). |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Renal function test -serum creatinine, serum urea,
serum uric acid, and blood urea nitrogen |
Baseline and after 1 week of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Random blood sugar level |
Baseline & after 1 week of intervention |
| Blood pressure & pulse rate |
Baseline & after 1 week of intervention |
| Pittsburgh Sleep Quality Index (PSQI) |
Baseline & after 1 week of intervention |
| Depression Anxiety Stress Scales (DASS21) |
Baseline & after 1 week of intervention |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/03/2025 |
| 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="1"
Months="2"
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
|
A Randomized controlled trial design will be adopted in this study. All the eligible participants
will be divided into 2 groups. The study group will undergo renal pack for 20 minutes a day,
daily, for a period of 1 week, while the control group will be undergo regular conventional
management for a period of 1 week. Assessments will be taken before and after the intervention. |