| CTRI Number |
CTRI/2025/03/081814 [Registered on: 06/03/2025] Trial Registered Prospectively |
| Last Modified On: |
25/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda Preventive Other (Specify) [Nasya Karma] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Role of Nasya ( Nasal Instillation) with Katutumbi Taila and Rasapachaka yoga in the management of Hypothyroidism. |
|
Scientific Title of Study
|
An Open Labelled Active Controlled Randomised Clinical Evaluation Of Nasya With Katutumbi Taila and Rasapachaka Yoga In The Management Of Hypothyroidism. |
| 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 Pooja Vekaria |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurved |
| Address |
OPD No 116 Department of kayachikitsa Parul Ayurved Hospital Parul University AP Limda TAL Waghodia Vadodara Gujarat 391760 India
Vadodara GUJARAT 391760 India |
| Phone |
8140374731 |
| Fax |
|
| Email |
vekariapooja206@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Dipeeka Surwase |
| Designation |
Associate Professor |
| Affiliation |
Parul Institute of Ayurved |
| Address |
OPD No 116 Department of kayachikitsa Parul Ayurved Hospital Parul University AP Limda TAL Waghodia Vadodara Gujarat 391760 India
Vadodara GUJARAT 391760 India |
| Phone |
9860750957 |
| Fax |
|
| Email |
drdipeeka77@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Dipeeka Surwase |
| Designation |
Associate Professor |
| Affiliation |
Parul Institute of Ayurved |
| Address |
OPD No 116 Department of kayachikitsa Parul Ayurved Hospital Parul University AP Limda TAL Waghodia Vadodara Gujarat 391760 India
GUJARAT 391760 India |
| Phone |
9860750957 |
| Fax |
|
| Email |
drdipeeka77@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul institute of Ayurved,Parul University,AP-Limda, TAL-Waghodia,Vadodara,Gujarat, India-391760 |
|
|
Primary Sponsor
|
| Name |
Parul Institute of Ayurved |
| Address |
Faculty of Ayurved, Parul University, AP-Limda, TAL-Waghodia, DIST-Vadodara, Gujarat, India-391760 |
| Type of Sponsor |
Private 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 Pooja Vekaria |
Parul Ayurved Hospital |
OPD No 116 Department of Kayachikitsa Parul Ayurved Hospital Parul University AP-Limda TAL-Waghodia Vadodara Gujarat 391760 India Vadodara GUJARAT |
8140374731
vekariapooja206@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee-Parul Institute of Ayurved Parul University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E039||Hypothyroidism, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nasya with Katutumbi Taila and Rasapachaka yoga |
Katutumbi Taila:
Reference:Yogratnakar Nidanasthana chapter 11/49
Route:Nasal
Dosage Form:Taila for Nasya for 7 days
Dose:6-6 drops
Frequency:od
Bhaishajyakal:Abhakta
Duration:60 days
Anupana/Sahapana:-
Rasapachaka Yoga:
Reference:Charak Samhita chikitsa sthana chapter 3/200
Route:oral
Dosage Form:vati for 23 days
Dose:4 tab (500 mg)
Frequency:Bd
Bhaishajyakal:Adhobhakta
Duration:60 days
Anupana/Sahapana:- water |
| Comparator Agent |
Tablet Thyrox |
Ongoing medicine
Drug form: Tablet
Route:Oral
Time:Empty Stomach
Duration:60 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient of either gender between age group 20 to 60 years.
Patient already diagnosed as hypothyroidism with or without medication as well as newly diagnosed.
Patient fulfilling the criteria of diagnosis according to billewicz diagnostic index and zulewski clinical score for hypothyroidism.
Patient with serum TSH value greater than 4.5 microIU per ml.
Patient with total serum T4 and total serum T3 value less than normal value and within normal value.(Total serum T4 is 4.5 to 12.5 microgram per dl and Total serum T3 is 80 to 220 nanogram per dl). |
|
| ExclusionCriteria |
| Details |
Patients who have undergone any type of thyroid surgery.
Patients suffering from Hashimoto’s thyroiditis.
Patients suffering from immunocompromised diseases.
Patients with active infective diseases like Tuberculosis, Hepatitis B.
Pregnant and lactating women.
Patients who are currently participating in any other clinical trials (since last 2 months).
Patients suffering from congenital hypothyroidism and secondary hypothyroidism.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of Nasya with Katutumbi taila and Rasapachaka Yoga in patients on the basis of T3, T4, TSH and LIPID PROFILE. |
T3, T4, TSH and LIPID PROFILE-On the screening visit and 60th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of Nasya with Katutumbi taila and Rasapachaka Yoga in patients on the basis of subjective parameters. |
On the screening visit, 15th day, 30th day and 60th day |
To study the safety of Nasya with Katutumbi taila and Rasapachaka yoga in
patients of hypothyroidism.
|
On the screening visit, 15th day, 30th day and 60th day |
|
|
Target Sample Size
|
Total Sample Size="48" Sample Size from India="48"
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)
|
01/04/2025 |
| 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="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
|
Hypothyroidism is a prevalent endocrine disorder
characterized by insufficient production of thyroid hormones, leading to a wide
range of metabolic, physiological and psychological disturbances. There is no
direct description of hypothyroidism in Ayurveda but based on its
clinical presentation hypothyroidism can be correlated with Galaganda.
In ayurveda, Galaganda occurs when there is vitiation of kapha
and Vata doshas, predominantly Kapha which further results in a
disturbance of Meda and Majja dhatus, resulting in the formation
of Galaganda. The thyroid gland is situated in Urdhwajatrugata Sthana,
which is a Kapha Sthana, for elimination of Kapha, Shirovirechana
has been described by Acharyas. Hence the management of hypothyroidism
by Nasya may be a better choice. Nasya has a direct influence on
the functioning of the thyroid gland. Hence in the current study, it is
proposed to evaluation of both Shodhana – Nasya with Katutumbi Taila
and Shamana- Rasapachaka yoga in comparision with standard control in
the management of Hypothyroidism. This study focus on early screening and
assessment of hypothyroidism through T3,
T4,TSH, LIPID PROFILE and Billewicz diagnostic index and Zulewski clinical
score as well as management of hypothyroidism through Nasya followed by Rasapachaka
yoga. Katutumbi taila and Rasapachaka yoga preparation will
be done. Pharmacological evaluation and standardization through GCMS, LCMS
and HPTLC. In trial group Nasya
will be done for 7 days followed by Rasapachaka yoga given in dosage of
2 gm BD for 23 days, this cycle will be repeat in next month while in control
group Tablet Thyrox given in morning at empty stomach. |