| CTRI Number |
CTRI/2026/01/102426 [Registered on: 29/01/2026] Trial Registered Prospectively |
| Last Modified On: |
28/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of an Ayurvedic Arka in Hypo-thyroid condition. |
|
Scientific Title of Study
|
Preclinical and Clinical Evalution of a Polyherbal Arka Formulation for the management of Hypothyroidism : An Integrative Ayurvedic Approch |
| 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 Amit Kumar Taraphdar |
| Designation |
Professor of Dravyaguna Vijnana |
| Affiliation |
Institute of Post Graduate Ayurvedic Education and Research at SVSP Hospital |
| Address |
Dept. of Dravyaguna, Room No.- T-7, Institute of Post Graduate Ayurvedic Education and Research at SVSP Hospital,
294/3/1 A.P.C Road, Kolkata
Kolkata
WEST BENGAL
700009
India |
| Phone |
9874849650 |
| Fax |
|
| Email |
atipgaer@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Kumar Taraphdar |
| Designation |
Professor of Dravyaguna Vijnana |
| Affiliation |
Institute of Post Graduate Ayurvedic Education and Research at SVSP Hospital |
| Address |
Dept. of Dravyaguna, Room No.- T-7, Institute of Post Graduate Ayurvedic Education and Research at SVSP Hospital,
294/3/1 A.P.C Road, Kolkata
Kolkata
WEST BENGAL
700009
India |
| Phone |
9874849650 |
| Fax |
|
| Email |
atipgaer@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Md Shyfe |
| Designation |
Post graduate trainee |
| Affiliation |
Institute of Post Graduate Ayurvedic Education and Research at SVSP Hospital |
| Address |
Dept. of Dravyaguna Vijnana, Institute of Post Graduate Ayurvedic Education and Research at SVSP Hospital.
294/3/1 A.P.C Road.
Kolkata
WEST BENGAL
700009
India |
| Phone |
6289109950 |
| Fax |
|
| Email |
mdshyfe786@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Post Graduate Ayurvedic Education and Research at SVSP Hospital,Govt.of West Bengal.294/3/1,A.P.C.Road,Kolkata-700009 |
|
|
Primary Sponsor
|
| Name |
Institute of Post Graduate Ayurvedic Education and Research at SVSP Hospital |
| Address |
294/3/1, A.P.C. Road, Kolkata- 700009 |
| 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 Amit Kumar Taraphdar |
Institute of post graduate ayurvedic education and research at SVSP Hospital |
Dept. of Dravyaguna
Vijnana, Room no- T2,
Institute of Post Graduate
Ayurvedic Education and
Research at SVSP Hospital.
294/3/1 A.P.C Road
Kolkata
WEST BENGAL |
9874849650
atipgaer@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, IPGAE&R at SVSP |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E039||Hypothyroidism, unspecified. Ayurveda Condition: GALAGANDAH, (2) ICD-10 Condition:E018||Other iodine-deficiency related thyroid disorders and allied conditions. Ayurveda Condition: GALAGANDAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Arka prepared from Kanchanar bark,Varuna bark,Sunthi,Pippali,Marich, Reference: (Arka Prakasha,shasta satak, 2),( Bhava prakash nighantu), (Sastri JLN, Dravyaguna vijnana),, Route: Oral, Dosage Form: Arka, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Water), Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Recently diagnosed hypothyroidism (within 2–6 months) .
2.TSH equal and less than 10 mIU/L with subnormal T3/T4 levels
3.Presence of clinical signs and symptoms such as:
Dry skin
Weight gain
Periorbital puffiness
Cold intolerance
Bradykinesia
Decreased sweating
Normal Thyroid Reference Range :
TSH: 0.4–5.0 mIU/L
T3: 1.2–2.8 nmol/L
T4: 64–155 nmol/L |
|
| ExclusionCriteria |
| Details |
1. Confirmed or suspected hyperthyroidism
2. Neoplastic goitre, severe dyslipidemia, brittle nails, or excessive sluggishness
3. Known systemic illnesses (e.g., tuberculosis, diabetes mellitus, HIV)
4. Pregnant or lactating women
5. Any prior use of thyroid medication exceeding 2 months |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome will be measured based on clinical outcome, Elevating Blood serum T3,T4, reducing TSH levels outcome. Alleviating clinical symptoms associated with Hypothyroidism, providing a standardized safe, and affordable Ayurvedic alternative for long-term management of hypothyroidism. |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Effect of test drug on quality of life among the patients suffering from Hypothyroidism |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
13/05/2026 |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [atipgaer@gmail.com].
- For how long will this data be available start date provided 02-11-2027 and end date provided 25-12-2099?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The clinical study ,which will take place at OPD and IPD of the IPGAE&R at SVSP hospital, is a single arm open level study for 4 weeks among 20 patients suffering form hypothyroidism. Primary Objective: To evaluate the anti-hypothyroid potential of a traditionally prepared Arka formulation containing Kanchanara bark, Varuna bark, and Trikatu through pharmacognostic, phytochemical, toxicological, and pharmacological (preclinical and clinical) studies. Secondary Objective: To develop a standardized, cost-effective, and safe polyherbal Ayurvedic formulation for the management of hypothyroidism.
|