| CTRI Number |
CTRI/2024/08/072754 [Registered on: 20/08/2024] Trial Registered Prospectively |
| Last Modified On: |
16/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of alternate hot and cold neck pack and ujjayi pranayama on hypothyroidism. |
|
Scientific Title of Study
|
Effect of short term intervention of alternate hot and cold throat pack and ujjayi pranayama on Hypothyroid patients along with naturopathy treatment- 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 |
Komal Kumari |
| Designation |
Junior resident student |
| Affiliation |
Rajiv gandhi university of health and sciences, karnataka, India-560041 |
| Address |
SDM college of Naturopathy and Yogic Sciences, First floor, Department of Naturopathy and yoga, room number 2, Ujire, Belthangady
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9632309240 |
| Fax |
|
| Email |
komal.kumari14679@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Komal Kumari |
| Designation |
Junior Resident |
| Affiliation |
Rajiv gandhi university of health and sciences, karnataka, India-560041 |
| Address |
SDM college of Naturopathy and Yogic Sciences,First floor, Department of Naturopathy and yoga, room number 2, Ujire, Belthangady
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9632309240 |
| Fax |
|
| Email |
komal.kumari14679@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harshini |
| Designation |
Assistant Professor |
| Affiliation |
SDM college of Naturopathy and Yogic Sciences, Ujire, Belthangady |
| Address |
SDM college of Naturopathy and Yogic Sciences, Department of Yoga therapeutics, First floor, room number 2, Ujire, Belthangady
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9482645833 |
| Fax |
|
| Email |
harshiniraghavendra@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM Yoga and nature cure hospital Shanthivana, Dharmasthala, Belthangady, Karnataka, India.
Pincode- 574240 |
|
|
Primary Sponsor
|
| Name |
Komal Kumari |
| Address |
SDM college of Naturopathy and Yogic Sciences, Ujire, Belthangady, karnataka, India
pincode-574240 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Harshini |
SDM Yoga and Nature Cure Hospital |
Female Treatment Section, Ground floor, Hydrotherapy Department, SDM yoga and nature cure hospital, Shanthivana, Dharmasthala.
pincode-574216
Dakshina Kannada
KARNATAKA |
9482645833
harshiniraghavendra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Dharmastala manjunatheshwara Naturopathy and Yoga Ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E02||Subclinical iodine-deficiency hypothyroidism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Alternate hot and cold throat pack and Ujjayi pranayama along with other naturopathy treatments. |
THROAT PACK
duration- 20 minutes once daily for period of 10 days.
1.It consists of three or four folds of linen cloth and a dry woolen cloth.
2.First linen cloth is dipped in hot water ( 98-104°F )and wrung and wrapped around neck.
3.Over linen cloth dry woolen cloth is wrapped for 3 minutes.
4.Then linen cloth is again dipped in cold water ( 55- 65°F) and wrung , then wrapped around neck and over it dry woolen cloth is wrapped for 1 minute
5.It is covered completely to prevent circulation of air inside the cloth around neck.
6.It is repeated for 3- 4 times with hot and cold water alternatively for 20 minutes daily.
UJJAYI PRANAYAMA
20 minutes twice daily (morning and evening) for the period of 10 days.
1.Adapt any meditative pose with spine erect and eyes close.
2.Slowly take a long, deep inhalation from both the nostrils
3.As you inhale, try contracting the throat and sensing the air pass through throat.
4.Be mindful to prevent the air from touching inside of your nose.
5.When the air touches the throat, a distinct sound is created.
6.Maintain a light and relaxed breathing pattern while gently constricting the back of your throat, creating a soft hissing sound during both inhalation and exhalation.
7.The sound should not be forced, but it should be audible enough for someone nearby to hear it.
8.Finally, exhale by closing your right nostril and releasing the breath through the left nostril.
NATUROPATHY TREATMENT - 10 days ( 2 treatments per day morning and afternoon each for 15-20 minutes)
includes-
Sauna bath,
Steam bath,
Neutral underwater massage ( 2 times in 10 days),
Neutral immersion bath,
Cold immersion bath,
Cold circular jet,
Neutral douche to whole body,
Alternate douche to whole body,
Neutral spinal spray,
Delux hydro massage,
Cold hip bath,
Neutral hip bath,
GH pack,
Cold water enema(3 times for 3 consecutive days),
Full body massage,
Partial massage,
Salt glow oil massage,
Powder massage and
Full mud bath
|
| Comparator Agent |
naturopathy treatments |
NATUROPATHY TREATMENT:
10 days ( 2 treatments per day morning and afternoon each for 15-20 minutes) includes- Sauna bath, Steam bath, Neutral underwater massage ( 2 times in 10 days treatment), Neutral immersion bath, cold immersion bath, Cold circular jet, Neutral douche to whole body, Alternate douche to whole body, Neutral spinal spray, Delux hydro massage, Cold hip bath, Neutral hip bath, GH pack, Cold water enema ( 3 times for 3 consecutive days), Full body massage, Partial massage, Salt glow oil massage, Powder massage and Full mud bath. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
People who were suffering from hypothyroidism as per diagnostic criteria and who are willing to give consent for participation in the study. |
|
| ExclusionCriteria |
| Details |
1.Nervous system or respiratory ailments
2.Cardiovascular disease, renal complications, liver disorders and locomotors disabilities.
3.People with hyperthyroidism, Hashimoto’s thyroiditis, Grave’s disease, thyroid toxicosis , thyroidectomy , goiter and psychiatric disorders.
4.There should not be any history of stroke, road traffic accident, spinal cord injury, and disc herniation that cause the symptoms.
|
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Thyroid profile
serum T3, serum T4 and TSH
|
base line before starting intervention and after 10 days of intervention
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Body mass index |
base line before starting intervention and after 10 days of intervention
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
27/08/2024 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
EFFECT OF SHORT-TERM INTERVENTION OF ALTERNATE HOT AND COLD THROAT PACK AND UJJAYI PRANAYAMA ON HYPOTHYROID PATIENTS ALONG WITH NATUROPATHY TREATMENT- RANDOMIZED CONTROLLED TRIAL.
Hypothyroidism is one of the endocrine disease of the thyroid, where longstanding phramacological intervention has more side effect and more cost. we planned to conduct a study with the reference of previous research with the aim of alternate hot and cold Throat pack and Ujjayi pranayama, would be benefited in patient with hypothyroidism.
method: Study group: (n=30) Alternate hot and cold throat pack + Ujjayi pranayama along with other naturopathic intervention for the period of 10 days Control group: (n=30)Only naturopathic treatment without throat pack and ujjayi pranayama for 10 days
Outcome variable: Primary outcome: Thyroid profile (Serum T3, T4 and TSH) Secondary outcome: Body mass index
data will be collected at the baseline before starting the intervention and after the 10 days of intervention
|