| CTRI Number |
CTRI/2024/12/077657 [Registered on: 04/12/2024] Trial Registered Prospectively |
| Last Modified On: |
29/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To see the effect of an Ayurvedic medicine in the management of constipation during pregnancy |
|
Scientific Title of Study
|
A randomized open labelled controlled clinical study to evaluate the efficacy of Haritakyadi Yoga in the management of Garbhini vibandha W.S.R constipation during pregnancy. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Monika |
| Designation |
MS Scholar Prasuti Tantra Evam Stree Roga |
| Affiliation |
Institute for Ayurved Studies and Research Umri road sector 08 Kurukshetra Haryana 136118 |
| Address |
Opd no 15 Department of Prasuti Tantra Evam Stree Roga Institute for Ayurved Studies and Research Umri Road sector 08 Kurukshetra Haryana 136118
Kurukshetra HARYANA 136118 India |
| Phone |
9896929060 |
| Fax |
|
| Email |
drmonikayadav09@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Jitesh Kumar Panda |
| Designation |
Professor and H.O.D , Department or Prasuti Tantra Evam Stree Roga |
| Affiliation |
Institute for Ayurved Studies and Research Umri road sector 08 kurukshetra Haryana 136118 |
| Address |
Room no 112 PG Department of Prasuti Tantra Evam Stree Roga Institute for Ayurved Studies and Research Umri road sector 08 Kurukshetra Haryana 136118
Kurukshetra HARYANA 136118 India |
| Phone |
9896033056 |
| Fax |
|
| Email |
drjk67@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Monika |
| Designation |
MS Scholar Prasuti Tantra Evam Stree Roga |
| Affiliation |
Institute for Ayurved Studies and Research Umri road sector 08 Kurukshetra Haryana 136118 |
| Address |
Opd no 15 Department of Prasuti Tantra Evam Stree Roga Institute for Ayurved Studies and Research Umri Road sector 08 Kurukshetra Haryana 136118
Kurukshetra HARYANA 136118 India |
| Phone |
9896929060 |
| Fax |
|
| Email |
drmonikayadav09@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute for Ayurved Studied and Research Umri road sector 08 Kurukshetra Haryana 136118 |
|
|
Primary Sponsor
|
| Name |
Dr Monika |
| Address |
Opd no 15 Department of Prasuti Tantra Evam Stree Roga Institute for Ayurved Studies and Research Umri road sector 08 Kurukshetra Haryana 136118 |
| 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 Monika |
Institute For Ayurved Studies and Research, umri road sector 08, Kurukshetra, Haryana. |
Room no 15, Department of Prasuti Tantra Evam Stree Roga. Kurukshetra HARYANA |
9896929060
drmonikayadav09@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shri Krishna Ayush University Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O269||Pregnancy related conditions, unspecified. Ayurveda Condition: GARBINIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Haritakyadi Yoga, Reference: Harita Samhita tritya sthan 51/10, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 15(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -Guda), Additional Information: patient can add guda according to her taste | | 2 | Comparator Arm (Non Ayurveda) | | - | syrup Lactulose | patient will take 15 ml of syrup lactulose with plenty of water twice a day after meal for 7 days |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1 Patients having confirm diagnosis of pregnancy.
2 Patients presenting the classical symptoms of Garbhini
Vibandha.
3 All patient diagnosed with Vibandha during 2nd and 3rd
trimester of pregnancy (both primigravida and multigravida).
4 Patients who are willing to sign consent form and participate
in clinical trial.
|
|
| ExclusionCriteria |
| Details |
1 Age less than 21 and more than 35 years.
2 Patients of 1st trimester of pregnancy.
3 Patients who are not fulfilling the inclusion
criteria.
4 Patients with Haemoglobin less than 8gm%.
5 Vibandha caused due to any medical and surgical
condition.
6 Patient with PIH (Pregnancy induced
hypertension)and GDM (Gestational Diabetes
Mellitus) and High-risk pregnancies (Molar
pregnancy and Ectopic pregnancy). |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Trial drug will help in management of constipation during pregnancy
|
follow up on 3rd day 7th day 15th day and 21st day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Trial drug will help to manage other associated symptoms |
follow up on 3rd day 7th day 15th day & 21st day |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/02/2025 |
| 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="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
|
Vibandha is not described as a separate disease in our Samhitas. It is described under symptoms of many diseases like Ajeerna, Samadosha, Koshthaashrita vata, Gudagata vata, Pakwasyagata vata. The term Vibandha is mentioned with different context to Pureesha like Malasanga, Viddgraha, Vishtambha, Malabadhata, Stabhapureeshata. It occurs due to Vikruti of Apana vata and the Srotas involved is Pureeshavaha Srotas. Gastrointestinal disorders are frequently experienced during pregnancy. As far as gastrointestinal complaints go, constipation is the most frequent, second after to nausea. During pregnancy upto 40% of women experience constipation symptoms at some point. The word Constipation comes from Latin word ‘Constipare’ which means – To press or crowd together. It refers to persistent,difficult, infrequent or seemingly incomplete defecation. It is defined as infrequent passage of hard stool. Patient may also complain of straining, a sensation of incomplete evacuation and either perineal or abdominal discomfort. It is a symptom, not an illness. Constipation is quite common ailment during Pregnancy. Atonicity of the gut due to effect of Progesterone, diminished physical activity and pressure of the gravid uterus on the pelvic colon are the possible explanations. Emotional disturbances, Iron supplements, disturbed sleep are the other causes which leads to Constipation. Suppression of defecation urge is also a very important cause of Constipation. It may cause backache and abdominal discomfort. Regular bowel movements may be facilitated by regulation of diet by taking plenty of fluids, vegetables and milk or prescribing stool softners at bed time. There may be rectal bleeding, painful fissures or haemorrhoids due to hard stool. |