| CTRI Number |
CTRI/2023/02/050057 [Registered on: 24/02/2023] Trial Registered Prospectively |
| Last Modified On: |
23/02/2023 |
| 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
|
To know the efficacy of patoladi kwatha along with navaka guggulu in polycystic ovarian syndrome
|
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Scientific Title of Study
|
A randomized open labelled controlled clinical study to evaluate the efficacy of patoladi kwatha along with navaka guggulu in polycystic ovarian syndrome with special reference to “artavakshayaâ€
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sonu Mariam Rajan |
| Designation |
PG Scholar |
| Affiliation |
Sri sri college of ayurvedic science and research hospital, kanakapura road, udayapura, bengaluru |
| Address |
Opd-10
Sri sri college of ayurvedic science and research hospital, kanakapura road, udayapura, bengaluru
Sri sri college of ayurvedic science and research hospital, kanakapura road, udayapura, bengaluru
Bangalore
KARNATAKA
560082
India |
| Phone |
9986783079 |
| Fax |
|
| Email |
sonumariamrajan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rachana bhat |
| Designation |
Professor of PTSR dept |
| Affiliation |
Sri sri college of ayurvedic science and research hospital, kanakapura road, udayapura, bengaluru |
| Address |
Opd-10
Sri sri college of ayurvedic science and research hospital, kanakapura road, udayapura, bengaluru
Sri sri college of ayurvedic science and research hospital, kanakapura road, udayapura, bengaluru
Bangalore
KARNATAKA
560082
India |
| Phone |
9535744077 |
| Fax |
|
| Email |
dr.rachanabhat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonu Mariam Rajan |
| Designation |
PG Scholar |
| Affiliation |
Sri sri college of ayurvedic science and research hospital, kanakapura road, udayapura, bengaluru |
| Address |
Opd-10
Sri sri college of ayurvedic science and research hospital, kanakapura road, udayapura, bengaluru
Sri sri college of ayurvedic science and research hospital, kanakapura road, udayapura, bengaluru
Bangalore
KARNATAKA
560082
India |
| Phone |
9986783079 |
| Fax |
|
| Email |
sonumariamrajan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Sri College of Ayurvedic science And Research Hospital.
Udaypura, kanakapura road 21st km Post. Bengaluru.
Pin-560082 |
|
|
Primary Sponsor
|
| Name |
Dr Sonu Mariam Rajan |
| Address |
Sri sri college of ayurvedic science and research centre, kanakapura road, udayapura. 21st km post, Bangalore. |
| Type of Sponsor |
Other [self] |
|
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Details of Secondary Sponsor
|
| Name |
Address |
| Dr Rachana H V |
Sri sri college of ayurvedic science and research centre, Bangalore. |
| NIL |
NIL |
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sonu Mariam Rajan |
PTSR department. Room no -10. Sri sri college of ayurvedic science and research hospital, Bangalore. |
Sri sri college of ayurvedic science and research hospital 21st KM kanakapura main road udayapura post 560082
Bangalore
KARNATAKA |
9986783079
sonumariamrajan@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Sri Institutional Ethical Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N830||Follicular cyst of ovary. Ayurveda Condition: ARTAVAKSHAYAH, (2) ICD-10 Condition:E888||Other specified metabolic disorders. Ayurveda Condition: ARTAVAKSHAYAH, |
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Intervention / Comparator Agent
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| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: varunadi kwatha along with tab kanchanara guggulu, Reference: bhaishajya ratnavali, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 25(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -luke warm water), Additional Information: -tab kanchanara guggulu (500mg)BD, after food | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Patoladi kwatha, Reference: Bhaishajya reatnavalli and chakradatta, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 25(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -luke warm water), Additional Information: -tab Navaka guggulu 500mg bd after food |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. Subjects between the age group of 18 years to 40 years, irrespective of marital status.
2. Subjects with Rotterdam criteria.
3. Subjects presenting with the classical symptoms of Artavakshaya.
4. Subjects presenting with the symptoms of oligomenorrhea, secondary amenorrhea or hypomenorrhea.
5. Polycystic ovary (5 or more follicles in at least one ovary measuring 2-9mm) confirmed with USG |
|
| ExclusionCriteria |
| Details |
1. Subjects with primary amenorrhea.
2. Subjects using of oral contraceptives (current or within the last 3 months).
3. Subjects with menorrhagia, metrorrhagia, menometrorrhagia will be excluded.
4. Subjects suffering from malignancies and chronic systemic diseases. |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in no of ovarian cysts and regularize the menstrual cycles. |
12 weeks |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| normalize the LH:FSH ratio |
12 weeks |
|
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Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 1/ Phase 2 |
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Date of First Enrollment (India)
|
25/02/2023 |
| 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="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
The study is A RANDOMIZED OPEN LABELLED CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF PATOLADI KWATHA ALONG WITH NAVAKA GUGGULU IN POLYCYSTIC OVARIAN SYNDROME WITH SPECIAL REFERENCE TO ARTAVAKSHAYA in 30 patients, will be held in SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH HOSPITAL BENGALURU, KARNATAKA IN PRASUTI TANTRA AND STREE ROGA DEPARTMENT. The primary outcome measures will be reduction of number of follicular cyst and regularise menstrual cycle, secondary outcome measures will be normalise the LH and FSH ratio. |