| CTRI Number |
CTRI/2025/12/098538 [Registered on: 05/12/2025] Trial Registered Prospectively |
| Last Modified On: |
03/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
An Ayurvedic Approach to Hypothyroidism: Comparing the Effect of Kombatnakhi Guggulu, Navyadi Kashayam, and Shigrubeejadi Nasya in Kaphavrutta Vata” |
|
Scientific Title of Study
|
a clinico comparative study of kombatnakhi guggulu and navyadi kashayam along with shigrubeejadi nasya in the management of hypothyroidism wsr to kaphavrutta vata
|
| 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 sachin koli |
| Designation |
pg scholar department of kayachikitsa |
| Affiliation |
govt dhanvantari ayurvedic hospital ujjain mp |
| Address |
opd no 28 govt dhanvantari ayurvedic hospital kayachikitsa department ujjain mp
dhanvantari ayurvedic hospital kayachikitsa department ujjain mp
Ujjain
MADHYA PRADESH
456006
India |
| Phone |
9584153250 |
| Fax |
|
| Email |
kolisachin248@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
vandana saraf |
| Designation |
associate proofessor |
| Affiliation |
govt.dhanvantari ayurvedic college and hospital ujjain mp |
| Address |
opd no 28 dhanvantari ayurvedic hospital kayachikitsa department ujjain mp
dhanvantari ayurvedic hospital kayachikitsa department ujjain mp
Ujjain
MADHYA PRADESH
456006
India |
| Phone |
8085740020 |
| Fax |
|
| Email |
vandana13ishnavi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
vandana saraf |
| Designation |
associate proofessor |
| Affiliation |
govt dhanvantari ayurvedic college and hospital ujjain mp |
| Address |
opd no 28 dhanvantari ayurvedic hospital kayachikitsa department ujjain mp
dhanvantari ayurvedic hospital kayachikitsa department ujjain mp
Ujjain
MADHYA PRADESH
456006
India |
| Phone |
8085740020 |
| Fax |
|
| Email |
vandana13ishnavi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mini pharmacy Govt.Dhanvantari Ayurvedic college mangalnath ujjain pin 456001 |
|
|
Primary Sponsor
|
| Name |
govt dhanvantari ayurvedic college and hospital chimanganj mandi agar road ujjain mp |
| Address |
govt dhanvantari ayurvedic college and hospital chimanganj mandi agar road ujjain mp pin code 456001 |
| 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 SACHIN KOLI |
Govt. Auto Dhanvantari ayurvedic medical college and hospital |
Chimangunj mandi agar road , OPD no-28, Kayachikitsa Department,ujjain M.P. India pincode - 456006
MADHYA PRADESH
Ujjain
MADHYA PRADESH |
09584153250
kolisachin248@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee govt dhanwantari ayurveda medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E02||Subclinical iodine-deficiency hypothyroidism. Ayurveda Condition: KAPAVRUTAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: kombatnakhi guggulu, Reference: NA, Route: Oral, Dosage Form: Guggulu, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: luke warm water ), Additional Information: no | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: navyadi kashayam, Reference: NA, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 30(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: no | | 3 | Comparator Arm | Procedure | - | nashyam | (Procedure Reference: ch.shidhhi.9/116, Procedure details: nasya karma is classicaal ayurvedic panchkarma procedure involving the instillation of medicated oil through the nasal route after preparatory facial massage & fomentation.)
|
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
all genders,patients with sign and symptoms of kaphavruta vata like shaitya (feeling of coldness),gaurav (heaviness),shula (pain),langhan (loss of appetite), rukshan (dryness of skin) |
|
| ExclusionCriteria |
| Details |
pregnant and lactating women.
patients who have undergone thyroid surgery.
patient having a chronic systemic illness like tuberculosis severe mentak illness.
all complicated case of hypothyroidism goitre,myxoedema ,thyroid cancer. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to reduce the intensity of classical sign and symptoms like shaitya, gaurav, shula, langhan, rukshan |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to reduce the intensity of classical sign & symptoms like shaitya gaurav shula langhan rukshan |
8 week gradually decrease the intensity of classical sign & symptoms like shaitya gaurav shula langhan rukshan |
|
|
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)
|
18/12/2025 |
| 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)
|
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
|
This is a Randomised interventional study of Kombatnakhi guggulu and Navyadi kashayam along with Shigrubeejadi tail nasya on Kaphavruta vata W.S.R. Hypothyroidism total 60 patients will be enrolled in present study. selected patients will be decided into three groups A containing 20 patients will be given Kombatnakhi guggulu along with shigrubeejdi tail nasyam and group B 20 patientS given Navyadi kashayam along with shighrubeejadi tail nasyam and group C 20 patients will be given Shighrubejadi tail nasyam with placebo follow up will be on every 15 days. |