| CTRI Number |
CTRI/2026/01/101857 [Registered on: 23/01/2026] Trial Registered Prospectively |
| Last Modified On: |
23/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic
Preventive
Screening |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical trial of Amrutadi Guggulu in Hypothyroidism along with Thyroxine |
|
Scientific Title of Study
|
An open labelled randomized controlled trial to evaluate efficacy of Amrutadi Guggulu as an add on effect in the management of Hypothyroidism along with Thyroxine |
| 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 YOGESH TUKARAM KOTANGALE |
| Designation |
Professor |
| Affiliation |
MAMs Sumatibhai Shah Ayurved College Hadapsar Pune |
| Address |
OPD NO 2
First Floor
Kayachikitsa OPD
Saneguruji Arogya Kendra
Malwadi Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
09423218193 |
| Fax |
|
| Email |
drytk@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SHRADDHA HARAJI MULEY |
| Designation |
PG SCHOLAR |
| Affiliation |
MAMs Sumatibhai Shah Ayurved College Hadapsar Pune |
| Address |
OPD NO 2
First Floor
Kayachikitsa OPD
Saneguruji Arogya Kendra
Malwadi Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
9373834860 |
| Fax |
|
| Email |
muleshraddha1351@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SHRADDHA HARAJI MULEY |
| Designation |
PG SCHOLAR |
| Affiliation |
MAMs Sumatibhai Shah Ayurved College Hadapsar Pune |
| Address |
OPD NO 2
First Floor
Kayachikitsa OPD
Saneguruji Arogya Kendra
Malwadi Hadapsar Pune
MAHARASHTRA
411028
India |
| Phone |
9373834860 |
| Fax |
|
| Email |
muleshraddha1351@gmail.com |
|
|
Source of Monetary or Material Support
|
| MAMs Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune Maharashtra State India 411028 |
|
|
Primary Sponsor
|
| Name |
Dr Shraddha Haraji Muley |
| Address |
MAMs Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune Maharashtra State India 411028 |
| Type of Sponsor |
Other [Self] |
|
|
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 Shraddha Haraji Muley |
Saneguruji Arogya Kendra |
Malwadi Hadapsar Pune Maharashtra State India 411028
Pune
MAHARASHTRA |
9373834860
muleshraddha1351@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E039||Hypothyroidism, unspecified. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Thyroxine | 25 mcg to 100 mcg | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Amrutadi gugulu, Reference: Bhashjya Ratnawali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients between the ages of 19 years to 50 years with irrespective sex, cast, religions.
2) Thyroid stimulating hormone (TSH) level more than 4.25
3) Patient currently on Tab. Thyroxine 25 mcg to 100 mcg
4) Chronicity of hypothyroidism below 5 years.
5) Patients suffering from Hypothyroidism. |
|
| ExclusionCriteria |
| Details |
1. Patients having any other major complicated systematic diseases like cardiac disease, diabetes mellitus.
2. Drugs (Amiodarone, Lithium) induce Hypothyroidism.
3. Pregnancy and lactating mother.
4. Hypothyroidism caused due to the administration of chemotherapy, radiotherapy and post
thyroidectomy. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the efficacy of the Amrutadi Guggulu as an add-on effect in reduction of the
symptoms of Hypothyroidism in 45 day |
at baseline, 2 weeks, 4 weeks and 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
02/03/2026 |
| 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 - NO
|
|
Brief Summary
|
1. Acharyas have described all the aspects of the disease very minutely. The management aspect of the disease is also deal with equal perfection. But we cannot find direct co-relation with a single disease from Ayurveda classics, though condition is suggestive of pathologies like Dhatvagnimandhya or Dhatvagni Vikriti, Sthaulya, Medorog or Medodosh etc. In the pathogenesis of Hypothyroidism according to the principles of Ayurveda, we find that it is basically caused due to dys-functioning of the Agni. Hypo functioning of Jatharagni, which affects Dhatvagni, eventually, brings out pathological sequence and ultimately, the diseased condition developed. The part of the Jatharagni, which works on the Dhatu parlances and its exacerbation diminution causes respective Dhatu Vriddhi and Dhatu Kshay. 3. In today’s perspective it is difficult to treat thyroid disorders only with Ayurveda drugs. 4. Now the time has come for evaluation of add-on therapy in such type of diseases. Add-on means, that which assists especially a drug added to a prescription to hasten or increase the action of the drug. Thus, for the management of Hypothyroidism, an add -on therapy besides increasing the action of modern drugs directly on the hormones should be initiated which can reduce time and also make the treatment more cost- effective. 5. Ayurveda with great hope has a golden treasure of natural ways of healing and a vast pharmacopoeia of Rasayana drugs that can provide such an effective add-on therapy. Keeping wellbeing of humanity as chief concern, if the best of two pathy are combined, without making much choose about the purity of science, an effective and successful.Once in mind this study has been planned to provide better, safer and faster relief to patients suffering from Hypothyroidism and for this purpose this ‘Amrutadi Guggulu’ has been used. |