| CTRI Number |
CTRI/2023/08/056496 [Registered on: 14/08/2023] Trial Registered Prospectively |
| Last Modified On: |
05/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the clinical efficacy of Nili (Indigofera tinctoria Linn.) Panchanga Churna and its hydroalcoholic extract on Vatarakta. |
|
Scientific Title of Study
|
An analytical & comparative clinical study of Nili (Indigofera tinctoria Linn) panchanga churna and its hydroalcoholic extract on Vatarakta |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kunjal Sureshbhai Patel |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurved College and Hospital, Vadodara |
| Address |
Post graduate department of Dravyaguna, Government Ayurved
College and Hospital, Ajwa Road, Dhanwantari marg, Panigate,
Vadodara
GUJARAT
390019
India
Vadodara
GUJARAT
390019
India |
| Phone |
8849199795 |
| Fax |
|
| Email |
nita.kunjal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Dharmendra Jani |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurved College and Hospital, Vadodara |
| Address |
Post graduate department of Dravyaguna, Government Ayurved
College and Hospital, Ajwa Road, Dhanwantari marg, Panigate,
Vadodara
GUJARAT
390019
India
College and Hospital, Ajwa road, Dhanwantari marg, Panigate,
Vadodara
GUJARAT
390019
India |
| Phone |
9898424365 |
| Fax |
|
| Email |
drjani13@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kunjal Sureshbhai Patel |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurved College and Hospital, Vadodara |
| Address |
Post graduate department of Dravyaguna, Government Ayurved
College and Hospital, Ajwa Road, Dhanwantari marg, Panigate,
Vadodara
GUJARAT
390019
India
GUJARAT
390019
India |
| Phone |
8849199795 |
| Fax |
|
| Email |
nita.kunjal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post graduate department of Dravyaguna, Government Ayurved College and Hospital, Ajwa
road, Dhanwantari marg, Panigate, Vadodara-390019 |
|
|
Primary Sponsor
|
| Name |
Government Ayurved Hospital Vadodara |
| Address |
Post graduate department of Dravyaguna, Government Ayurved
Hospital, Ajwa road, Dhanwantari marg, Panigate, Vadodara-390019 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Kunjal Patel |
Government Ayurved Hospital, Vadodara |
OPD Dravyaguna
Department Vadodara
Gujarat
Vadodara
GUJARAT
Vadodara
GUJARAT |
8849199795
nita.kunjal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE Government Ayurved College and Hospital Vadodara |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M109||Gout, unspecified. Ayurveda Condition: VATARAKTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Nili, Reference: Bhavprakasha Nighantu, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: Koshnajala), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Hydroalcoholic extract of Nili Panchanga | Dosage form- capsule
Dose- 2 capsule (300mg each) bd
Aaushadhkala- Pragbhakta
Anupana- Koshnajala
Route Of Administration- Oral
Duration- 4 weeks |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
65.00 Day(s) |
| Gender |
Both |
| Details |
1)Sandhi Pradeshe Shoola/ Nistoda/ Bheda (Pain/ pricking / tearing pain in joint)
2)Sphurana-Ayama (Twitching sensation - Stretching)
3)Rakta/ Tamra / Shyava Twak (Reddish/copper/ bluish discolouration of skin)
4)Sparshasahata (Tenderness)
5)Sandhi Pradeshe Daha (Burning sensation over joint area)
6)Kandu (Itching)
7)Sandhi Pradeshe Shotha (Swelling over joint area)
8)Ruk Bhutva Bhutva (Episodic pain)
9)Atisweda/ Asweda (Hydrosis/anhydrosis)
10)Supti (Numbness)
11)Alasya (Lethargy)
12)Sadanam (fatigue)
13)Pidikodgam/ Mandalotpatti (Apperance of papules/ patches)
14)Kshate ati ruka (Severe pain on injury)
|
|
| ExclusionCriteria |
| Details |
Age less than 18yrs and greater than 65yrs.
Pregnant women and lactating mother.
Patients with the Updrava of Vatarakta.
Patients with other Systemic diseases such as Diabetes Mellitus, Hypertension, Cardiac anomaly, Renal & hepatic disorders.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Definite change in serum uric acid level |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Sandhi Pradeshe Shoola/ Nistoda/ Bheda (Pain/ pricking / tearing pain in joint)
2)Rakta/ Tamra / Shyava Twak (Reddish/copper/ bluish discolouration of skin)
3)Sparshasahata (Tenderness)
4)Kandu (Itching)
5)Sandhi Pradeshe Shotha (Swelling over joint area) |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="33" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/11/2023 |
| Date of Study Completion (India) |
12/06/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Clinical study has obtained Institutional Ethics committee clearance (GAC/VAD/IEC/81/2023, Date-24/01/2023) and registered at Clinical Trial Registry of India, ICMR, New Delhi, vide CTRI/2023/08/056496, [Registered on 14/08/2023]. Study type was randomized single-blind, parallel arm clinical trial. 36 patients were enrolled and divided into two groups (i.e., Group A –Nili Panchanga Churna, Group B – Hydroalcoholic extract of Nili Panchanga) 18 patients in each group were allocated. Total 33 patients (i.e., 15 patients in group A and 18 patients in Group B) completed the study. All individual of two groups A and B were having significant difference in percentage in Vatarakta. In Group A- Sandhi Pradeshe Shoola (65.56%), Sphurana-Ayama (33.33%), Rakta/Tamra/Shyava Twak (26.67%), Sparshasahata (20%), Sandhi Pradeshe Daha (37.78%), Kandu (26.67%), Sandhi Pradeshe Shotha (54.44%) and Supti (26.67%) results were observed. In Group B- Sandhi Pradeshe Shoola (40.74%), Sphurana-Ayama (11.11%), Rakta/Tamra/Shyava Twak (27.78%), Sparshasahata (12.96%), Sandhi Pradeshe Daha (28.70%), Kandu (11.11%), Sandhi Pradeshe Shotha (23.15%) and Supti (12.96%) results were observed. Significant difference observed between group A and B.
|