| CTRI Number |
CTRI/2026/02/102926 [Registered on: 03/02/2026] Trial Registered Prospectively |
| Last Modified On: |
02/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A comparative study of two Ayurvedic medicine combinations in the management of irregular periods in overweight women with PCOS” |
|
Scientific Title of Study
|
Comparative study of Amritadyaguggulu with Kanashatahwadi kashayam and
Navaka guggulu with
Chitrakagrandhyadi kashayam
in the management of
oligomenorrhoea among
overweight women with PCOS. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sreelekshmi P S |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurveda College Tripunithura |
| Address |
Department of Streeroga and Prasutitantra, Government Ayurveda College Tripunithura,682301
Ernakulam
KERALA
682301
India |
| Phone |
9497526314 |
| Fax |
|
| Email |
drsree.sreyas@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shahina Mole S |
| Designation |
Professor And HOD |
| Affiliation |
Government Ayurveda College Tripunithura |
| Address |
Department of Streeroga and Prasutitantra, Government Ayurveda College, Tripunithura,682301
Ernakulam
KERALA
682301
India |
| Phone |
9495718796 |
| Fax |
|
| Email |
shahinamoleabdulmajeed@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shahina Mole S |
| Designation |
Professor and HOD |
| Affiliation |
Government Ayurveda College Tripunithura |
| Address |
Department of Streeroga and Prasutitantra, Government Ayurveda College, Tripunithura
Ernakulam
KERALA
682301
India |
| Phone |
9495718796 |
| Fax |
|
| Email |
shahinamoleabdulmajeed@gmail.com |
|
|
Source of Monetary or Material Support
|
| GOVERNMENT AYURVEDA COLLEGE TRIPUNITHURA |
|
|
Primary Sponsor
|
| Name |
SREELEKSHMI P S |
| Address |
PG SCHOLAR
DEPARTMENT OF STREEROGA AND PRASUTITANTRA , GOVERNMENT AYURVEDA COLLEGE TRIPUNITHURA |
| 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 SREELEKSHMI P S |
Government Ayurveda College Tripunithura |
DDepartment of Streeroga and Prasutitantra, Government Ayurveda College, Tripunithura,Ground floor Hospital building
Ernakulam
KERALA |
9497526314
drsree.sreyas@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Government Ayurveda College, Tripunithura |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E282||Polycystic ovarian syndrome. Ayurveda Condition: ARTAVAVAHA-SROTODUSHTIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Amrithadya Guggulu, Reference: Chakradutta, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -Honey), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kanashatahwadi kashaya, Reference: Chikitsa Manjari, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -Hingu choornam), Additional Information: - | | 3 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Navaka Guggulu, Reference: Ashtanga Hridaya, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: - | | 4 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Chitrakagrandhyadi kashaya, Reference: Ashtanga hridaya, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -Vida lavana, saindhava lavana,hingu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Poly cystic ovarian syndrome patients diagnosed according to ESHRE/ASRM criteria 2018.
BMI greater than or equal to 25 to less than or equal to 35 |
|
| ExclusionCriteria |
| Details |
Pregnancy and lactating mothers
Patients with primary amenorrhoea
Known case of uncontrolled diabetes and uncontrolled hypertension
Known case of systemic illness like cardiovascular diseases, kidney, liver diseases Haemoglobin less than 7grampercentage
Use of statins or other medicines known or suspected to affect reproductive or metabolic functions
Known cases of Malignancy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the effect of Amritadyaguggulu with Kanashatahwadi Kashayam against Navakaguggulu with Chitrakagrandhyadi Kashayam in changing Body mass index (BMI) in PCOS subjects with BMI greater than or equal to 25 to less than or equal to 35
To compare the effect of Amritadyaguggulu with Kanashatahwadi Kashayam against Navakaguggulu with Chitrakagrandhyadi Kashayam in changing interval of menstrual cycles done by grading |
Assessment will be done on first,31st,61st, 91st day and after followup(121st day) based on mean changes in the BMI, interval of menstrual cycle |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of Amritadyaguggulu with Kanashatahwadi Kashayam against Navakaguggulu with Chitrakagrandhyadi Kashayam in changing ovarian morphology (volume, number of follicles) in USG in PCOS |
Assessment will be done on the first and 91st day based on changes in the ovarian morphology in USG (volume, number of follicles). |
| To compare the effect of Amritadyaguggulu with Kanashatahwadi Kashayam against Navakaguggulu with Chitrakagrandhyadi Kashayam in changing the waist circumference. |
Assessment will be done on first,31st,61st, 91st day and after followup(121st day) based on changes in waist circumference. |
|
|
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)
|
15/02/2026 |
| 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
|
Polycystic Ovarian Syndrome (PCOS) is a common endocrine disorder affecting women of reproductive age, characterized by oligo/anovulation, hyperandrogenism and polycystic ovarian morphology on ultrasonography. The condition has significant reproductive, metabolic and psychological implications including infertility, irregular menstrual cycles, obesity, cardiovascular diseases, Type 2 diabetes mellitus and increased risk of endometrial carcinoma. The present study is to evaluate the effect of Amritadyaguggulu with Kanashatahwadi kashayam in comparison against Navakaguggulu with Chitrakagrandhyadi Kashaya in the management of oligomenorrhoea among overweight women with PCOS. Study design is an Interventional study- Comparative clinical trial with a targeted sample size of 30 participants in each group. Eligible female subjects aged 18-45 years, diagnosed with Polycystic Ovarian Syndrome are recruited from the Outpatient Department of Streeroga and Prasoothitantra at Government Ayurveda College Hospital, Tripunithura. Sampling method will be consecutive sampling. In 1st group Amritadyaguggulu 1 BD with Kanashatahwadi Kashayam 48 ml twice daily before food and in 2nd group Navakaguggulu 1 BD with Chitrakagrandhyadi Kashayam 48 ml twice daily before food is given for a study period of 90 days starting from the 1st day of visit excluding the days of menstruation. Assessment occurs on the first,31st,61st,91st and 121st days focusing on changes in BMI, changes in mean interval of menstrual cycles and waist circumference. Additionally, participants will undergo assessment on first and 91st day examining changes in ovarian morphology. |