| CTRI Number |
CTRI/2025/11/097004 [Registered on: 06/11/2025] Trial Registered Prospectively |
| Last Modified On: |
07/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Comparative Study On Nasya Karma With Nirgundi Tail And Oral Administration Of Jalakumbhi Bhasma With Varuna Kwath In Cases Of Galganda(Hypothyroidism) |
|
Scientific Title of Study
|
A Comparative Study On Nasya Karma With Nirgundi Tail And Oral Administration Of Jalakumbhi Bhasma With Varuna Kwath In Cases Of Galganda(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 Shivani Sharma |
| Designation |
M.D. Scholar |
| Affiliation |
Government PG Ayurvedic College and Hospital, Chaukaghat, Varanasi |
| Address |
Department Of Panchakarma, Government PG Ayurvedic College and Hospital, Chaukaghat, Varanasi
Varanasi
UTTAR PRADESH
221001
India |
| Phone |
6005300688 |
| Fax |
|
| Email |
shivani.sharma990600@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivani Sharma |
| Designation |
M.D. Scholar |
| Affiliation |
Government PG Ayurvedic College and Hospital, Chaukaghat, Varanasi |
| Address |
Department Of Panchakarma, Government PG Ayurvedic College and Hospital, Chaukaghat, Varanasi
Varanasi
UTTAR PRADESH
221001
India |
| Phone |
6005300688 |
| Fax |
|
| Email |
shivani.sharma990600@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivani Sharma |
| Designation |
M.D. Scholar |
| Affiliation |
Government PG Ayurvedic College and Hospital, Chaukaghat, Varanasi |
| Address |
Department Of Panchakarma, Government PG Ayurvedic College and Hospital, Chaukaghat, Varanasi
Varanasi
UTTAR PRADESH
221001
India |
| Phone |
6005300688 |
| Fax |
|
| Email |
shivani.sharma990600@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government P.G. Ayurvedic College and Hospital, Varanasi |
|
|
Primary Sponsor
|
| Name |
Government PG Ayurvedic College and Hospital,Chaukaghat, Varanasi |
| Address |
Department of Panchakarma, Government P.G. Ayurvedic College and Hospital, Varanasi |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Shivani Sharma |
Government PG Ayurvedic College and Hospital, Chaukaghat, Varanasi |
OPD NO. 11 and IPD of Kayachikitsa and Panchakarma, Government PG Ayurvedic College and Hospital, Chaukaghat, Varanasi
Varanasi
UTTAR PRADESH |
06005300688
shivani.sharma990600@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, Government Ayurveda College and Hospital, Varanasi, U.P.,Mahayogi Guru Gorakhnath AYUSH University, Gorakhpur, U.P. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E039||Hypothyroidism, unspecified. Ayurveda Condition: GALAGANDAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Jalkumbhi bhasma , Reference: Chakradutta, Route: Oral, Dosage Form: Bhasma, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 56 Days, anupAna/sahapAna: Yes(details: Varuna kwatha), Additional Information: - | | 2 | Comparator Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: Chakradutta, Procedure details: Purvakarma
1.After collection of necessary materials.
2 examination of Patient will be done.
3.Snehana (Mridu Abhyanga) Swedana ( Tapa sweda).
Pradhana karma
1.Administration of Nirgundi taila( 8-8 drops ) to each nostril once a day.
Paschat karma
1.After administration of Nasya yoga Dhumpana( eranda nala) and kavala will be given.)
(1) Medicine Name: Nirgundi taila, Reference: Chakradutta, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 8(drops), Frequency: od, Duration: 56 Days |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Patients with classical signs and symptoms of Galganda (Hypothyroidism) will be taken for the study, Patients between age group 15-55yrs Both genders male and female, Patients who are newly diagnosed with Hypothyroidism increased TSH levels (TSH level between 5.6-15 ulU/ml),Patients irrespective of sex, religion, socio economic status, occupation and habitat, Patients having chronicity less than one year, Patients who are Yogya for Nasya Karma. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| relieve in the common symptoms like puffiness of face, bilateral peripheral oedema, constipation, fatigue, hoarseness of voice, agnimand weight gain |
relieve in the common symptoms like puffiness of face, bilateral peripheral oedema, constipation, fatigue, hoarseness of voice, agnimand weight gain |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| complete resolve in the chief complains of hypothyroidism |
56 days |
|
|
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)
|
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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This study is Randomized , Parallel group comparitive study trial on Nasya Karma With Nirgundi Taila and Jalakumbhi Bhasma With Varuna Kwath In cases of Galganda (HYPOTHYROIDISM). Patients will be selected randomly from OPD and IPD of Department of Kayachikitsa and Panchakarma, Government P.G. Ayurvedic College and Hospital, Varanasi. A total no. of 60 patients will be studied under three groups having 20 patients in each group- Group A: In this group, 20 patients will be treated with Nirgundi taila NASYA for 21 days with interval of 7 days for consecutive 56 days. Group B: In this group, 20 patients will be treated with JALAKUMBHI BHASMA with VARUNA KWATH done in two sitting with interval of 7 days for 56 days. Group C- In this group 20 patients will be treated with NASYA KARMA with Nirgundi taila and Jalakumbhi Bhasma With Varuna Kwath In two sitting with interval of 7 days for 56 days Two follow ups will be done - First on 15th day after completion of treatment and Second follow will be after 1 month completion of treatment in each group. |