| CTRI Number |
CTRI/2025/03/081498 [Registered on: 03/03/2025] Trial Registered Prospectively |
| Last Modified On: |
22/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
a clinical comparative study to evaluate the efficacy of Kanchnar Guggulu Vatika and Hamsapadiadi Kashaya in the management of avatu granthi vikar w.s.r. Hypothyroidism |
|
Scientific Title of Study
|
a clinical comparative study to evaluate the efficacy of kanchnar guggulu vatika and hamsapadiadi kashaya in the management of avatu granthi vikar w.s.r. hypothyroidism |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
VANDANA SIDAR |
| Designation |
PG Scholar Department of Kayachikitsa |
| Affiliation |
Shri Narayan Prasad Awasthi Government Ayurveda College Raipur Chhattisgarh |
| Address |
OPD number 02 and 18 Department of Kayachikitsa, Shri Narayan Prasad Awasthi Government Ayurveda College Raipur Department of Kayachikitsa, Shri Narayan Prasad Awasthi Government Ayurveda College Raipur Raipur CHHATTISGARH 492010 India |
| Phone |
8770376276 |
| Fax |
|
| Email |
vs170530@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR S D KHICHARIYA |
| Designation |
Reader in Department of Kayachikitsa |
| Affiliation |
Shri Narayan Prasad Awasthi Government Ayurveda College Raipur Chhattisgarh |
| Address |
OPD number 2 and 18 Department of Kayachikitsa Shri Narayan Prasad Awasthi Government Ayurveda College Raipur
Raipur CHHATTISGARH 492010 India |
| Phone |
8109196400 |
| Fax |
|
| Email |
drkhichariya@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DR ARUNA OJHA |
| Designation |
Professor in Department of Kayachikitsa |
| Affiliation |
Shri Narayan Prasad Awasthi Government Ayurveda College Raipur Chhattisgarh |
| Address |
OPD number 2 and 18 Department of Kayachikitsa Shri Narayan Prasad Awasthi Government Ayurveda College Raipur
Raipur CHHATTISGARH 492010 India |
| Phone |
9424401858 |
| Fax |
|
| Email |
arunaojha90@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Kayachikitsa Shri
Narayan Prasad Awasthi Government Ayurveda College Raipur Chhattisgarh, Pin 492010, India |
|
|
Primary Sponsor
|
| Name |
Department of Kayachikitsa Shri Narayan Prasad Awasthi Government Ayurveda College Raipur |
| Address |
Shri Narayan Prasad Awasthi Government Ayurveda College Raipur Chhattisgarh, Pin 492010, India |
| Type of Sponsor |
Other [Government Ayurveda College Raipur Chhattisgarh, 492010, India] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Department of Kayachikitsa Shri Narayan Prasad Awasthi Government Ayurveda College Raipur |
Shri Narayan Prasad Awasthi Government Ayurveda College Raipur Chhattisgarh |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vandana Sidar |
Shri Narayan Prasad Awasthi Government Ayurveda College Raipur |
opd number 02 and 18 and ipd in the Department of Kayachikitsa Shri Narayan Prasad Awasthi Government Ayurveda College Raipur Raipur CHHATTISGARH |
8770376276
vs170530@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITEE GOVERNMENT AYURVED COLLEGE RAIPUR (C.G.) 492010 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E038||Other specified hypothyroidism. Ayurveda Condition: GALAGANDAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Hamsapadiadi Kashaya, Reference: Vaidyamanorama, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kanchnaar Guggulu , Reference: Vangsen, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
It is based on clinical signs and symptoms mentioned in modern and ayurvedic classics, especially loss of appetite, puffiness, constipation, weight gain with the help of WHO Scoring of Ayurveda Symptoms. |
|
| ExclusionCriteria |
| Details |
1.Patients below 18 years & above 60 years of age will not be taken.
2. Pregnancy & lactating mother.
3. TSH level more than 15.
4. T3 and T4 level are lower tahn normal.
5. Patients with a prior history of head and neck radiation.
6. patients having Hypothyroidism with complications.
7. Patients undergoing any known hormonal therapy.
8. The patients underwent any thyroid surgery or had an already diagnosed case of carcinoma.
9. Patients with long-term steroid treatment.
10. Recent participation in other clinical trial.
11. Severe mental disorder.
12. History of hypersensitivity to any of the trials and their ingredients.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| reduce the associated symptoms of Avatu Granthi Vikar (Hypothyroidism) |
reduce the associated symptoms of Avatu Granthi Vikar in 8 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improve the quality of life |
90 Days |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/04/2025 |
| 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
|
Acharya Charaka categorize
Hypothyroidism in Anukta Vyadhies means
any disease which is not explained in Ayurvedic text but
studied and treated on the basis of Kupit Dosha, Hetu, and
their Sthan. The
term Hypothyroidism is not mentioned directly in Ayurvedic texts,
but the problems related to Thyroid Disorders were well
described
under the disorder known as Galaganda
(Enlarged thyroid gland).
An analysis
of the symptomatology of
hypothyroidism, in the light of the Ayurvedic
principle of Doshas & Dushya, showed in the Hypothyroidism
there is a hypo activity of Agni at Koshta and Dhatu level with the analysis of symptomatology of
Hypothyroidism there’s a vatiation of Kapha-Vata Doshas . The lakshanas depend on the extent of involvement of
Dhatus. So, the fundamental treatment
principle in Hypothyroidism is to restore the Karmukata of Agni at both Kostha and Dhatu levels. This can be achieved through Ama Pachanam, Agni Deepanam, Srotosodhanam and
administration of appropriate Rasayanam. Here Agni
becomes diminished at the level of Dhatus and Sanga srotas which
results in impairment of Dhatu function
and leads to the symptoms as seen in hypothyroidism.[ By keeping
all these things in my minds the select drugs will be fruitful in effective
management of the disease rectifying Agnimandhya and Kapha-Medo dushti.
The volunteers
will be informed about the study protocol
and willing participants will be randomly selected as per the coin
method. Clinical research format
will be prepared and validated before the
study approval will be taken from the IEC of
the Shri NPA
Govt. Ayurved College and
hospital, Raipur C.G. and CTRI
registration will be done. After selection,
each participant will be tasted
individually and selected according to the assessment
criteria. Sixty patients of Avatu Granthi Vikar will be
selected from Kayachikitsa OPD and IPD Shrihri NPA
government Ayurved college
and hospital, Raipur C.G. The
case
selection was in regards to age, sex, occupation, and
socio-economic conditions. Both acute and chronic
phases of Avatu Granthi Vikar patients
were
taken for the study, following the WHO scoring of Ayurveda Symptoms’s criteria
for diagnosing
Avatu Granthi Vikar as well
as the clinical features of Hypothyroidism
described in modern medicine. The present study is a single-center, open-labeled
randomized (coin method) clinical trial. A total
of 60 clinically diagnosed and registered
patients of Hypothyroidism
were divided randomly by coin method
into three groups. Each group will have 20 patients.
Group A: 20 clinically diagnosed patients
of Hypothyroidism will be
treated with Kanchnar Guggulu Vatika 2
tablets (each 500 mg) two times in
a day with lukewarm water before meal for 90 days.
Group B: 20
clinically diagnosed patients of Hypothyroidism
were
treated with Hmasapadiadi Kashaya 40 ml two
times in a day
before meal with anupana madhu for 90 days along.
Group C: 20 patients diagnosed with Avatu Granthi Vikar were
treated with both trial drugs Kanchnar Guggulu Vatika (2Tab)
and Hamsapadiadi Kashaya (40ml)
two times a day before meal.
|