| CTRI Number |
CTRI/2025/10/096363 [Registered on: 22/10/2025] Trial Registered Prospectively |
| Last Modified On: |
21/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to test the safety and effectiveness of Qust Shirin (a Unani medicine) in people with hypothyroidism (underactive thyroid) |
|
Scientific Title of Study
|
A Randomized, Parallel Group, Open Label, Active Controlled Clinical Study to evaluate the Safety and Efficacy of Qust Shirin (Saussurea lappa) compared with Levothyroxine in the Management of Qillat-i-Darqiyyat Asli (Primary 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 |
Afifa Naz Sayyed Nasehuddin |
| Designation |
PG Scholar |
| Affiliation |
National Research Institute of Unani Medicine for Skin Disorders Hyderabad |
| Address |
Department of Moalajat, National Research Institute of Unani Medicine for Skin Disorders, AGs Colony Road Erragadda Hyderabad
National Research Institute of Unani Medicine for Skin Disorders, AGs Colony Road Erragadda Hyderabad
Hyderabad
TELANGANA
500038
India |
| Phone |
9860661938 |
| Fax |
|
| Email |
afi.syd.bsl@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Qamar Uddin |
| Designation |
Professor |
| Affiliation |
National Research Institute of Unani Medicine for Skin Disorders Hyderabad |
| Address |
Department of Moalajat, National Research Institute of Unani Medicine for Skin Disorders, AGs Colony Road Erragadda Hyderabad
National Research Institute of Unani Medicine for Skin Disorders, AGs Colony Road Erragadda Hyderabad
Hyderabad
TELANGANA
500038
India |
| Phone |
8700027178 |
| Fax |
|
| Email |
qamaruddindr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Qamar Uddin |
| Designation |
Professor |
| Affiliation |
National Research Institute of Unani Medicine for Skin Disorders Hyderabad |
| Address |
Department of Moalajat, National Research Institute of Unani Medicine for Skin Disorders, AGs Colony Road Erragadda Hyderabad
National Research Institute of Unani Medicine for Skin Disorders, AGs Colony Road Erragadda Hyderabad
Hyderabad
TELANGANA
500038
India |
| Phone |
8700027178 |
| Fax |
|
| Email |
qamaruddindr@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Research Institute of Unani Medicine for Skin Disorders, AGs Colony Road Erragadda Hyderabad, Telangana 500038 India. |
|
|
Primary Sponsor
|
| Name |
National Research Institute of Unani Medicine for Skin Disorders Hyderabad |
| Address |
National Research Institute Of Unani Medicine for Skin Disorders,
AG colony Road, Opp. ESI Hospital, Erragadda, Hyderabad-500038 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Central Council for Research in Unani Medicine CCRUM |
Ministry of Ayush Ayush Bhavan, B block , GPO complex, INA, New Delhi- 110023 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Afifa Naz Sayyed Nasehuddin |
National Research Institute Of Unani Medicine for Skin Disorders, Hyderabad |
Moalajat OPD No. 1, Dept. of Moalajat, OPD Block,National Research Institute of Unani Medicine for Skin Disorders. AGs Colony Road, Opp. ESI Hospital, Erragadda,Hyderabad- 500038
Hyderabad
TELANGANA |
9860661938
afi.syd.bsl@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee NRIUMSD Hyderabad |
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 |
| Comparator Agent |
Levothyroxine |
Levothyroxine in the dose of one tablet (100 microgram) Once daily orally with water at least 30 minutes before Breakfast.The starting dose in newly diagnosed cases will be One tablet (50 microgram) Once daily Orally with water for 4 weeks followed by One tablet(100 microgram) Once daily Orally with water for the next 4 weeks |
| Intervention |
Qust Shirin (Saussurea Lappa) |
Qust Shirin (Saussurea lappa) 1g (powder)
Twice daily Orally in the form of capsule. 2 capsules (500mg each) twice daily
Orally With water after meals for 8 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Participants who meet the following criteria will be included in the study:
1. Individuals of any gender
2. Aged between 18 and 60 years
3. Participants diagnosed with symptomatic subclinical
primary Hypothyroidism with elevated TSH(10-20mIU/L)
and normal Free T4/T3)
4. Participants diagnosed with overt primary
Hypothyroidism with elevated TSH (10-20mIU/L) and low
free T4 |
|
| ExclusionCriteria |
| Details |
The following participants will be excluded from the study:
1. Individuals aged Below 18 years or Above 60 years
2. TSH Level Less than 10mIU/L or More than 20mIU/L
3. Asymptomatic cases of Subclinical Primary Hypothyroidism
4. Severe or complicated cases of Overt Primary Hypothyroidism
5. Patients with Drug-induced Hypothyroidism
6. Patients undergoing radiotherapy to the head or neck region
7. Individuals who have undergone thyroidectomy
8. Pregnant or Lactating Women
9. Patients with significant pulmonary, cardiovascular, hepatic, or renal
diseases
10. Known cases of immunocompromised states (e.g., HIV/AIDS) or malignancies
11. Patients with Diabetes Mellitus
12. Individuals with a history of hypersensitivity to Qust Shirin
13. Patients unwilling or unable to comply with the treatment schedule |
|
|
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 |
Primary Outcome Measures
1.Change in Serum Thyroid Stimulating Hormone (TSH) Levels from baseline to 8 weeks of Treatment
2. Change in Serum Free Thyroxine (FT4) Levels from baseline to 8 weeks of Treatment |
At Baseline and 8 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Monitoring Adverse Events (AEs)
Adverse effects related to either the Unani drug or control drug
will be documented at each clinical assessment visit (weeks 2,4,6 and 8), both as reported by the participants,and observed by the physician during clinical examination.
|
2,4,6 and 8 weeks |
1. Changes in Laboratory Parameters from baseline and at week 8
2. Change in Serum Free Triiodothyronine (FT3) Levels from baseline to week 8
3. Change in Zulewski’s Clinical Score from baseline to week 8
4. Change in Lipid Profile Parameter from baseline to 8 weeks of treatment
5. Change in Participants’ Quality of Life (QoL),assessed using the Thyroid-Dependent Quality of Life Questionnaire (ThyDQoL),from baseline to week 8 |
At Baseline and week 8 |
|
|
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 |
|
Date of First Enrollment (India)
|
11/11/2025 |
| 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 disorder in India, particularly among women, with significant regional and age-related variation. and poses a major public health concern. Although levothyroxine is the standard therapy, its improper use can lead to complications such as osteoporosis and cardiac issues. Traditional Unani medicine recognizes Qust Shirin (Saussurea lappa) for its hot and dry temperament and pharmacological properties including antioxidant, anti-inflammatory actions. Preclinical studies support its potential in restoring thyroid function, but clinical data remain limited. Hence, a well-designed clinical trial is warranted to assess the safety and efficacy of Qust Shirin in comparison with levothyroxine in managing primary hypothyroidism. Based on the above considerations, a clinical study titled A Randomized, Parallel Group, Open Label, Active Controlled Clinical Study to evaluate the Safety and Efficacy of Qust Shirin (Saussurea lappa) compared with Levothyroxine in the Management of Qillat-i-Darqiyyat Asli (Primary Hypothyroidism).has been designed. |