| CTRI Number |
CTRI/2022/07/043806 [Registered on: 07/07/2022] Trial Registered Prospectively |
| Last Modified On: |
09/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Ayurvedic therapy in management of sweta pardara (leucorrhea) |
|
Scientific Title of Study
|
Role of Nagkesara Churna and Panchavalkala Kashaya along with Panchavalkala Taila YoniPichu in treating Sweta Pradara W.S.R. to Bacterial Vaginosis- A Randomized Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Usha |
| Designation |
PG scholar |
| Affiliation |
National Institute of Ayurveda, Jaipur |
| Address |
National Insititute of Ayurveda, Prasuti Tantra and Stri Roga vibhag , 3rd floor , jorawar singh gate , jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9460417008 |
| Fax |
|
| Email |
dhamuusha20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PROF DR K BHARATHI |
| Designation |
HEAD OF DEPARTMENT |
| Affiliation |
National Institute of Ayurveda |
| Address |
Department of Prasuti Tantra Evam Stri Roga, National Insititute of Ayurveda, Jorawar singh gate , jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9492047131 |
| Fax |
|
| Email |
baruhunt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
PROF DR K BHARATHI |
| Designation |
HEAD OF DEPARTMENT |
| Affiliation |
National Institute of Ayurveda |
| Address |
Department of Prasuti Tantra Evam Stri Roga, National Insititute of Ayurveda, Jorawar singh gate , jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9492047131 |
| Fax |
|
| Email |
baruhunt@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda, Jaipur |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda |
| Address |
National Institute of Ayurveda, jorawar singh gate , jaipur , rajsthan , 302002 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
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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 Usha Dhamu |
NIA ( Deemed to be University ) OPD and IPD, jaipur |
opd 26,27 of National Insititute of Ayurveda, jorawar singh gate, Amer road, jaipur, Rajasthan
Jaipur
RAJASTHAN |
9460417008
dhamuusha20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, NIA |
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:N771||Vaginitis, vulvitis and vulvovaginitis in diseases classified elsewhere. Ayurveda Condition: SOMAROGAH/SVETAPRADARAH, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | yoni picu, योनि पिचॠ| (Procedure Reference: charak chikitsa 30, Procedure details: dimensions 2cm*2cm soaked in 10ml. of Panchavalkala Taila
• Dose: 10 ml in one sitting per day
• Route: Per Vagina
• Time of administration: after cessation of menses
• Duration of administration: for 15 day)
(1) Medicine Name: Panchavalkal tail, Reference: AFI III, Route: Vaginal, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Duration: 15 Days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Nagkeshar, Reference: Bhavprakash, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -takra), Additional Information: - | | 3 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Panchvalkala Kashaya , Reference: AFI III, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | | 4 | Comparator Arm | Procedure | - | yoni picu, योनि पिचॠ| (Procedure Reference: Charak chikitsa 30, Procedure details: dimensions 2cm*2cm soaked in 10 ml of Panchavalkala Taila)
• Dose: 10 ml in one sitting per day
• Route: Per Vagina
• Time of administration: after cessation of menses
• Duration of administration: for 15 days)
(1) Medicine Name: panchavalkala tail, Reference: AFI III, Route: Vaginal, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Duration: 15 Days |
|
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1.Married women aged between 20 years to 45 years
2.Patient agrees to use condom/ abstinence during the treatment period.
3.Patient agrees to refrain from use of douches, oral or intra-vaginal antibiotics or antifungal agents or lubricants during the entire study period.
4.Presence of 3 out of 4 Amsel’s diagnostic criteria for bacterial vaginosis:
5.Off white (milky or gray), thin, homogeneous, adherent vaginal discharge, with minimal or absent pruritus.
6.Vaginal ph > 4.5
7.Positive “whifftest†(fishy odor of the vaginal discharge with the addition of a drop of 10% koh).
8.Presence of clue cells ≥ 20% of the total epithelial cells on microscopic examination of the saline wet mount.
|
|
| ExclusionCriteria |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in Amsel’s diagnostic criteria for Bacterial vaginosis |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Normal Gram Stained Vaginal smear.
2. Scoring patterns
vaginal discharge(Verbal rating scale)
Low back ache(Visual analogue scale)
Dyspareunia(Verbal Rating Scale)
Vaginal Itching(Verbal Rating Scale)
Malodor (Verbal Rating Scale)
3. Improvement in Quality of life assess by SF 36 questionnaires. |
30 days |
|
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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" |
Phase of Trial
Modification(s)
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/07/2022 |
| 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="0"
Months="1"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
|
Brief Summary
|
In day to day practice the complaint of vaginal discharge is very common. Sweta Pradara is frequently accompanied with low back pain, lower belly pain, vagina l irritatinitching, burning sensations, and other vague discomforts, as well as overall debility, low backache, an other symptoms, all of which contribute to a decrease in the affected person ’s quality of life.Patients vafter taking allopathic medicines though get relief for some time but recurrence occurs in most of cases. SwetaPradara or white vaginal discharge affects women of all age groups but particularly those belonging to reproductiveage group. Since, this discharge occurs during the peak period of a woman’s life, it can greatly impair her normal style of functioning. NULL HYPOTHESIS [H0] • There is no difference in the effect of Nagakesara churna with panchavalkala taila yoni pichu and panchavalkala kashaya with panchavalkala taila yoni pichu in Sweta pradara with special reference to bacterial vaginosis. ALTERNATIVE HYPOTHESIS [H1] There is significant difference in the effect of Nagakesara churna with panchavalkala taila yoni pichu and panchavalkala kashaya with panchavalkala taila yoni pichu in Sweta pradara with special reference to bacterial vaginosis.In day to day practice the complaint of vaginal discharge is very common. Sweta Pradara is frequently accompanied with low back pain, lower belly pain, vagina l irritatinitching, burning sensations, and other vague discomforts, as well as overall debility, low backache, an other symptoms, all of which contribute to a decrease in the affected person ’s quality of life.Patients vafter taking allopathic medicines though get relief for some time but recurrence occurs in most of cases. SwetaPradara or white vaginal discharge affects women of all age groups but particularly those belonging to reproductiveage group. Since, this discharge occurs during the peak period of a woman’s life, it can greatly impair her normal style of functioning. NULL HYPOTHESIS [H0] • There is no difference in the effect of Nagakesara churna with panchavalkala taila yoni pichu and panchavalkala kashaya with panchavalkala taila yoni pichu in Sweta pradara with special reference to bacterial vaginosis. ALTERNATIVE HYPOTHESIS [H1] There is significant difference in the effect of Nagakesara churna with panchavalkala taila yoni pichu and panchavalkala kashaya with panchavalkala taila yoni pichu in Sweta pradara with special reference to bacterial vaginosis.In day to day practice the complaint of vaginal discharge is very common. Sweta Pradara is frequently accompanied with low back pain, lower belly pain, vagina l irritatinitching, burning sensations, and other vague discomforts, as well as overall debility, low backache, an other symptoms, all of which contribute to a decrease in the affected person ’s quality of life.Patients vafter taking allopathic medicines though get relief for some time but recurrence occurs in most of cases. SwetaPradara or white vaginal discharge affects women of all age groups but particularly those belonging to reproductiveage group. Since, this discharge occurs during the peak period of a woman’s life, it can greatly impair her normal style of functioning. NULL HYPOTHESIS [H0] • There is no difference in the effect of Nagakesara churna with panchavalkala taila yoni pichu and panchavalkala kashaya with panchavalkala taila yoni pichu in Sweta pradara with special reference to bacterial vaginosis. ALTERNATIVE HYPOTHESIS [H1] There is significant difference in the effect of Nagakesara churna with panchavalkala taila yoni pichu and panchavalkala kashaya with panchavalkala taila yoni pichu in Sweta pradara with special reference to bacterial vaginosis.In day to day practice the complaint of vaginal discharge is very common. Sweta Pradara is frequently accompanied with low back pain, lower belly pain, vagina l irritatinitching, burning sensations, and other vague discomforts, as well as overall debility, low backache, an other symptoms, all of which contribute to a decrease in the affected person ’s quality of life.Patients vafter taking allopathic medicines though get relief for some time but recurrence occurs in most of cases. SwetaPradara or white vaginal discharge affects women of all age groups but particularly those belonging to reproductiveage group. Since, this discharge occurs during the peak period of a woman’s life, it can greatly impair her normal style of functioning. NULL HYPOTHESIS [H0] • There is no difference in the effect of Nagakesara churna with panchavalkala taila yoni pichu and panchavalkala kashaya with panchavalkala taila yoni pichu in Sweta pradara with special reference to bacterial vaginosis. ALTERNATIVE HYPOTHESIS [H1] There is significant difference in the effect of Nagakesara churna with panchavalkala taila yoni pichu and panchavalkala kashaya with panchavalkala taila yoni pichu in Sweta pradara with special reference to bacterial vaginosis.In day to day practice the complaint of vaginal discharge is very common. Sweta Pradara is frequently accompanied with low back pain, lower belly pain, vagina l irritatinitching, burning sensations, and other vague discomforts, as well as overall debility, low backache, an other symptoms, all of which contribute to a decrease in the affected person ’s quality of life.Patients vafter taking allopathic medicines though get relief for some time but recurrence occurs in most of cases. SwetaPradara or white vaginal discharge affects women of all age groups but particularly those belonging to reproductiveage group. Since, this discharge occurs during the peak period of a woman’s life, it can greatly impair her normal style of functioning. NULL HYPOTHESIS [H0] • There is no difference in the effect of Nagakesara churna with panchavalkala taila yoni pichu and panchavalkala kashaya with panchavalkala taila yoni pichu in Sweta pradara with special reference to bacterial vaginosis. ALTERNATIVE HYPOTHESIS [H1] There is significant difference in the effect of Nagakesara churna with panchavalkala taila yoni pichu and panchavalkala kashaya with panchavalkala taila yoni pichu in Sweta pradara with special reference to bacterial vaginosis. |