| CTRI Number |
CTRI/2025/10/096723 [Registered on: 31/10/2025] Trial Registered Prospectively |
| Last Modified On: |
30/10/2025 |
| 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
|
Understanding Symptoms of Thyroid Imbalance and the effect of Ayurvedic Medicines Kanchanar Guggulu and Rasapachak Kwatha compare to Kanchanar Triphala Kwatha. |
|
Scientific Title of Study
|
A Cross-Sectional study on Rasavaha
Srotodushti Lakshana in primary Hypothyroidism and evaluating the therapeutic efficacy of Kanchanar Guggulu with Rasapachak Kwatha versus Kanchanara Triphala Kwatha on Thyroid function. |
| 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 Salve Arti Madhukar |
| Designation |
MD Scholar, Department Of Roga Nidana Evum Vikriti Vigyana |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Department of Roga Nidana Evum Vikriti Vigyana,3rd floor, Academic block, Block, All India Institute of Ayurveda, Gautampuri, Sarita Vihar, Mathura road, New Delhi
South
DELHI
110076
India |
| Phone |
8767781210 |
| Fax |
|
| Email |
salvearti9878@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shalini Rai |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Department of Roga Nidana Evum Vikriti Vigyana,3rd floor, Academic block, Block ,All India Institute of Ayurveda, Gautampuri, Sarita Vihar, Mathura road, New Delhi
South
DELHI
110076
India |
| Phone |
9389423843 |
| Fax |
|
| Email |
vd.raishalini@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Salve Arti Madhukar |
| Designation |
MD Scholar, Department Of Roga Nidana Evum Vikriti Vigyana |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Department of Roga Nidana Evum Vikriti Vigyana,3rd floor, Academic block, Block ,All India Institute of Ayurveda, Gautampuri, Sarita Vihar, Mathura road, New Delhi
South
DELHI
110076
India |
| Phone |
8767781210 |
| Fax |
|
| Email |
salvearti9878@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute Of Ayurveda Sarita Vihar New Delhi 110076 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Ayurveda |
| Address |
All India Institute of Ayurveda, Gautampuri, Sarita Vihar, Mathura road, New Delhi 110076 |
| 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 Salve Arti Madhukar |
All India Institute of Ayurveda |
Department of Roga Nidana Evum Vikriti Vigyana, OPD 8 and OPD 16 Ground floor, Hospital Block, All India Institute of Ayurveda, Gautampuri, Sarita Vihar,New Delhi 110076
South
DELHI |
8767781210
salvearti9878@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, All India Institute Of Ayurveda, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E039||Hypothyroidism, unspecified. Ayurveda Condition: ICD11, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Rasapachak Kwatha, Reference: Charak Chikitsa -3/200, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: Kanchanar Guggulu, Reference: Bhaish.Ratnavali-Galagand rog chikitsa, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -Luke warm water), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kanchanara-Triphala Kwatha, Reference: Gadanigrah-Galagand rogadhikara, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: Kanchanar Guggulu, Reference: Bhaish.Ratnavali-Galagand rog chikitsa,, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -Luke warm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Confirmed primary hypothyroidism TSH Greater than 4.5mIU/L to less than19mIU/L, low/normal T4.
Uncontrolled hypothyroidism’s Patients.
Willing to provide written Informed consent.
Patients having Symptoms of Rasadushti in any grade
Patient having symptoms of Rasadushti last for one month
No acute illnesses
|
|
| ExclusionCriteria |
| Details |
Secondary/tertiary hypothyroidism.
Patient with congenital hypothyroidism, goitorous hypothyroidism, transient hypothyroidism.
Pregnancy or lactation.
Comorbidities like CRF, known case of Hepatitis B, Jaundice, Tuberculosis, HIV, CAD, severe anaemia.
Patient whose symptoms are worsely aggravated after leaving the modern drug levothyroxine (for washout period of 8 days)
Mentally ill/retarded patients.
Patients with drug induced hypothyroidism, Recent thyroid surgery or radioiodine therapy within 1-year of the study.
Uncontrolled Diabetes Mellitus, hypertension.
Patient undergoing treatment for any other systemic illness.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in TSH (mIU/L) |
0 and 45th days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in T3,T4,clinical features of hypothyroidism-Rasavaha srotodushti lakshana score |
0 and 45th day. |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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)
|
01/01/2026 |
| 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 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
|
Hypothyroidism is the most common endocrine disorder that affects a significant portion of the global population. The prevalence of hypothyroidism in urban India is 10.95% with a greater incidence in females and elderly persons. The thyroid gland produces two hormones, Thyroxine (T4) and Triiodothyronine (T3). The deficiency of thyroid hormone is a common condition worldwide. It affects almost all body systems and has a wide variety of clinical presentations from being asymptomatic to, in rare cases, life threatening. Ayurveda does not currently have a description of any disease condition comparable to hypothyroidism. Yet, several references are scattered in various texts. Understanding of hypothyroidism as per Ayurvedic science suggests Kapha and Meda derangements, With the involvement of Kapha, Vata dosha, along with the Srotas involved are Rasavaha, Mamsavaha, Medovaha, Purishavaha, Annavaha, Pranavaha, Manovaha, and Arthavavaha. NEED OF THE STUDY:
On the basis of clinical manifestation and
etiological factors of hypothyroidism it may be considered primarily caused due
to Derangement of Agni, Rasavaha Srotas and Medovaha
Srotas as per ayurveda perspective.Some previous studies have documented the role of Rasavaha Sroto dushti in hypothyroidism, however, to the best knowledge of the authors, none of the previous studies have used validated performa (Questionnaire) for the same, which reduces their scientific credibility. This study may provide a deeper understanding
of the disease’s pathophysiology from an Ayurvedic perspective. It also helps
in identifying which symptoms are most prevalent or severe in this specific
population, guiding the development of more targeted interventions.
This study also plans for further confirmation of association between Rasavaha srotodushti lakshanas and hypothyroidism through the usage of Rasapachak Kwatha, which acts mainly on Rasa Dhatu. If the Rasapachak Kwatha can mitigate the symptoms of hypothyroidism it may uphold the association of Rasavaha Srotodushti lakshanas in hypothyroidism. Additionally, it may also demonstrate how Ayurvedic treatments can more effectively balance the disturbances in Rasavaha Srotas and provide a holistic approach to managing hypothyroidism.
AIM: Examine the relationship between Rasavaha Srotodushti symptoms and hypothyroidism by comparing the therapeutic effects of Rasapachak Kwatha combined with Kanchanar Guggulu versus Kanchnara Triphala Kwatha combined with Kanchanar Guggulu, based on various subjective and objective parameters. OBJECTIVE: Primary Objective: 1) To assess the therapeutic effects of Rasapachak Kwatha combined with Kanchanar Guggulu versus Kanchnara Triphala Kwatha combined with Kanchnar Guggulu on hypothyroidism, based on thyroid function (TSH). Secondary Objective: 1) To compare their impact on T3, T4, and clinical symptoms of hypothyroidism
|