| CTRI Number |
CTRI/2022/08/045045 [Registered on: 30/08/2022] Trial Registered Prospectively |
| Last Modified On: |
19/08/2022 |
| 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
|
Management of Polycystic Ovarian Syndrome by Ayurveda |
|
Scientific Title of Study
|
“A Comparative Study to Evaluate the Effect of Yog Basti (Lekhan
Aasthapana Basti and Lahshun Taila Anuvasana Basti) and Shamana Aushadha
(Vishwadi Guggulu and Aartava Pravartaka Yoga) in the Management of
Polycystic Ovarian Syndrome†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Soni Kapil |
| Designation |
Reader, Department of Prasuti Tantra evum Stree Rog |
| Affiliation |
RGGPG Ayurvedic College and Hospital, Paprola |
| Address |
Room no.203, Department of Prasuti Tantra evum Stree Rog, RGGPG Ayurvedic College and Hospital, Paprola, Distt. Kangra
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418499799 |
| Fax |
|
| Email |
skbhardwaj73@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Soni Kapil |
| Designation |
Reader, Department of Prasuti Tantra evum Stree Rog |
| Affiliation |
RGGPG Ayurvedic College and Hospital, Paprola |
| Address |
Room no.203, Department of Prasuti Tantra evum Stree Rog, RGGPG Ayurvedic College and Hospital, Paprola, Distt. Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418499799 |
| Fax |
|
| Email |
skbhardwaj73@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jyoti Thakur |
| Designation |
PG Scholar |
| Affiliation |
RGGPG Ayurvedic College and Hospital, Paprola, |
| Address |
Room no. 804, Department of Prasuti Tantra evum Stree Rog, RGGPG Ayurvedic College and Hospital, Paprola, Distt. Kangra
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418860189 |
| Fax |
|
| Email |
joyfuljolly1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Charak Pharmacy, RGGPG Ayurvedic College and Hospital |
| ISM Jogindernagar |
|
|
Primary Sponsor
|
| Name |
Principal RGGPG Ayurvedic College and Hospital Paprola |
| Address |
Principal Room, Admin Block, RGGPG Ayurvedic College and Hospital, Paprola, Distt. Kangra |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| HOD Department of Prasuti Tantra evum Stree Rog |
RGGPG Ayurvedic College and Hospital, Paprola, Distt. Kangra H.P. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Soni Kapil |
RGGPG Ayurvedic College and Hospital, Paprola |
OPD and IPD of Department of Prasuti Tantra evum Stree Rog, RGGPG Ayurvedic College and Hospital, Paprola
Kangra
HIMACHAL PRADESH |
9418499799
skbhardwaj73@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Human), RGGPG Ayurvedic College and Hospital, Paprola |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E282||Polycystic ovarian syndrome. Ayurveda Condition: ARTAVAKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बसà¥à¤¤à¤¿à¤•à¤°à¥à¤®/वसà¥à¤¤à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Shusruta Samhita Chikitsa Sthana 38/82, Procedure details: Lekhan Aasthapana Basti (960 ml per rectal) and Lahsun Taila anuvasna basti (120ml per rectal) in Yog Krama for 8 days. Procedure to be done once a day. )
| | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Vishwadi Guggulu, Reference: Bharat Bhaishajya Ratnakar, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Water), Additional Information: -(2) Medicine Name: Aartava Pravartaka Yoga, Reference: Ayurveda Saara Sangraha, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1) Patient willing to go through trial.
2) Affected individuals presented with two out of three criteria of
ASHRM/ESHRE (ROTTERDAM) CRITERIA 2013 given
below:
i) Oligomenorrhea or anovulation
ii) Hyperandrogenism clinical and biochemical
iii) Polycystic ovaries on sonographic examination
3) Clinically diagnosed and confirmed patients of PCOS. |
|
| ExclusionCriteria |
| Details |
1) Women of age less than 16 and above 35 years.
2) Patient having systemic disease like hypertension, tuberculosis, renal disease, thyroid disorders associated gynecological
disorders (fibroids, polyps or ovarian cyst).
3) Patient having congenital adrenal hyperplasia, androgen
secreting tumors.
4) Patient unable to give informed consent. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Regular menstrual cycle with proper ovulation and relief from existing symptoms. |
within 3 months from the start of medicine. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Feeling of well being and total relief from existing symptoms |
Within 6 months from the start of medicines. |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
01/09/2022 |
| 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
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Research report will be soon published after the completion of trial. 20 patients fulfilling the inclusion and exclusion criteria will be randomly selected from OPD and IPD of Department of Prasuti Tantra evum Stree Roga, RGGPG Ayurvedic College and Hospital, Paprola. Patients will be divided randomly into 2 groups; Group I and Group II each with 10 patients. Group I will be given Yog Basti for 8 days as per schedule for 3 consecutive cycles. Group II will be given Aartava Pravartaka Yoga 500mg BD and Vishwadi Guggulu 1gm BD for 3 consecutive cycles. Result will be assessed on the basis of subjective and objective assessment criteria |